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Biosimilars Deals 2021

Explore our interactive biosimilar news updates, collating tailored reports by brand, INN, originator/biosimilar applicant, litigation, region, or date. Alternatively, review our weekly BioBlast updates below.

Pearce IP BioBlast® for the week ending 23 October 2026

Oct 27, 2026

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®.  Significant biosimilar activities for the week ending 23 October 2026 are set out below:

Eculizumab

On 20 October 2026, Samsung Bioepis announced that, in partnership with Brazilian state-owned pharmaceutical laboratory, Bahiafarma, and Brazilian biotechnology… Read more here.

Denosumab

On 29 September 2026, the Subject Expert Committee (SEC) under India’s Central Drugs Standard Control Organisation (CDSCO) recommended the approval of… Read more here.

Omalizumab

On 16 October 2026, Genentech and Novartis commenced BPCIA proceedings in the US District Court for the District of Delaware against Amneal Pharmaceuticals… Read more here.

Biopharma Deals

On 21 October 2026, German-headquartered Formycon announced that it has entered into a collaboration with South American company, Biocelys, to develop an… Read more here.

Biopharma News

On 13 October 2026, the FDA published its final guidance for “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products” on the… Read more here.
 

 

On 7 October 2026, BioSpace reported that Palindrome Pharma, a new pharmaceutical company focused on biosimilar medicines, has launched in Canada… Read more here.

About Pearce IP

Pearce IP is a privately owned/independent, specialist, life-sciences focussed, intellectual property/law firm offering lawyers and attorneys in Australia and New Zealand.

Our lawyers and attorneys specialise in pharma, biopharma, biotech, ag-tech, food-tech, med-tech, although our work is broader than these industries.

Pearce IP and its leaders are ranked in every notable legal directory including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, Best Law Firms, among others. In 2025, Pearce IP was honoured by Australasian Lawyer and New Zealand Lawyer as a Top Specialist Firm, 5 Star Employer of Choice, and the “Standout Winner” for Inclusion and Culture (<100 employees).  

Pearce IP is the only leading IP firm in Australia and New Zealand with a female founder, and is certified by WEConnect International as women owned.

 

Naomi Pearce

Naomi Pearce

CEO, Executive Lawyer (AU, NZ), Patent & Trade Mark Attorney (Trans Tasman)

Naomi is the CEO and Founder of Pearce IP, and is one of ANZ’s leading IP practitioners. Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 29 years’ experience, and a background in molecular biology/biochemistry.

Ranked in virtually every notable legal directory, highly regarded by peers and clients, Naomi is renowned for her successful and elegant IP/legal strategies focussing on complex/multijurisdictional litigation, global FTO, and strategic advice.  Among other awards, Naomi is the 2026 Lexology Client Choice Winner for Patents, the 2024 Lawyers Weekly Women in Law “Executive of the Year”, the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology Client Choice Winner for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year”, and the 2021 Lawyers Weekly Women in Law “Partner of the Year”.  Ranked in Chambers Asia Pacific, Chambers Global,  IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks.

Pearce IP is the premier life sciences focussed firm in ANZ.  Commencing in 2017. Pearce IP is the 2025 Australasian Lawyer and NZ Lawyer 5-Star Employer of Choice & “Standout Winner” for Inclusion and Culture (<100 employees).  In 2021, Pearce IP was the Lawyers Weekly Australian Law Awards IP Team of the Year.

Chantal Savage

Chantal Savage

Special Counsel, Lawyer

Chantal is an intellectual property disputes lawyer with experience advising across the spectrum of IP rights, including patents, trade marks, copyright, plant breeder’s rights and trade secrets/confidential information. Recognised as a Rising Star in IP by the Legal 500 Asia Pacific (2021-2024), Chantal has previously worked for international and top tier law firms in Australia and the United Kingdom.

With a science degree specialising in molecular biology and biochemistry, Chantal’s practice focuses particularly on complex, high-value, multi-jurisdictional patent infringement and revocation proceedings for clients in the life sciences sectors.

Maliha Hoque

Maliha Hoque

Paralegal

Maliha is a Paralegal and contributing author to Pearce IP’s flagship circulars BioBlast® and BioGxPulse®.  She is currently completing her Juris Doctor at the University of Sydney.  With a background in medical science, finance and risk consulting, and an inquisitive mind, Maliha loves leaving ‘no stone unturned’ when investigating IP/legal ‘challenges’.  Maliha is interested in the intersection of law and science, and digital transformation.  She gets excited about using her science, business management, and legal skills and experience to support Pearce IP’s lawyers, attorneys and clients.

Naomi Pearce Named Among Australia’s Patent Elite in IAM Global Leaders 2027

Oct 23, 2026

Pearce IP’s Founder and CEO, Naomi Pearce has again been named as one of Australia’s patent elite in the 2027 edition of IAM Global Leaders.  This is the second consecutive year that Naomi has earned a place on the list.

Inclusion in IAM Global Leaders is reserved for individuals who not only rank Gold in the IAM Patent 1000 (the leading international directory of top patent firms and practitioners), but who also, as IAM Global Leaders states,

“merit special attention – not only because of their expertise and experience related to creating, protecting, managing, transacting and enforcing critical patent rights, but also for their ability to innovate, inspire and go above and beyond to deliver value for their clients”.

Naomi was ranked Gold in both Patent Litigation and Patent Prosecution in Australia in the latest edition.

Naomi is also recognised in the IAM Strategy 300 for both Legal, and IP Management Consultancy, having maintained these rankings for the past three consecutive years.

This latest recognition builds on the achievements of Pearce IP and five of its leaders, who were recognised in the IAM Patent 1000 for 2026, with rankings across Australia and New Zealand for Patent Litigation and Patent Prosecution.

Of Naomi Pearce, the IAM Patent 1000 noted:

“At the helm is Naomi Pearce, the firm’s Founder and CEO, whose dual qualifications as an executive lawyer and patent attorney shape Pearce IP’s integrated approach to life sciences IP. With a background in molecular biology and substantial experience in both private practice and in‑house environments, she is the strategic driver behind many of the firm’s most complex patent programmes.”

 

About Pearce IP

Pearce IP is a privately owned/independent, specialist, life-sciences focussed, intellectual property/law firm offering lawyers and attorneys in Australia and New Zealand.

Our lawyers and attorneys specialise in pharma, biopharma, biotech, ag-tech, food-tech, med-tech, although our work is broader than these industries.

Pearce IP and its leaders are ranked in every notable legal directory including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, Best Law Firms, among others. In 2025, Pearce IP was honoured by Australasian Lawyer and New Zealand Lawyer as a Top Specialist Firm, 5 Star Employer of Choice, and the “Standout Winner” for Inclusion and Culture (<100 employees).  

Pearce IP is the only leading IP firm in Australia and New Zealand with a female founder, and is certified by WEConnect International as women owned.

 

Formycon & Biocelys Collaborate on Undisclosed “Niche-Buster” Biosimilar, FYB286

Oct 21, 2026

On 21 October 2026, German-headquartered Formycon announced that it has entered into a collaboration with South American company, Biocelys, to develop an undisclosed biosimilar, FYB286.  Formycon refers to the biosimilar as a “niche buster”, a drug for a rare condition with global annual sales in the low- to mid-single-digit billion-dollar range.

The collaboration is aimed at combining Formycon’s experience in biosimilar development with Biocelys’ state-of-the-art manufacturing infrastructure.  Formycon expects demand for FYB286 to increase substantially, particularly in emerging markets, presenting an attractive market opportunity.

Biocelys is indirectly controlled by ATHOS KG, which is Formycon’s largest shareholder.  The project is being financed upfront by Santo Biosimilar GmbH, an affiliated company of ATHOS.  Under the agreement with Santo, Formycon will receive arm’s-length compensation for its development services and will participate in future revenues of Santo with a low double-digit percentage share.  The co-operation agreement between Formycon and Biocelys covers joint development, manufacture, regulatory approval and supply management of FYB286.

Alvotech/Dr Reddy’s Biosimilar Denosumab PFS Recommended in India

Oct 21, 2026

On 29 September 2026, the Subject Expert Committee (SEC) under India’s Central Drugs Standard Control Organisation (CDSCO) recommended the approval of Alvotech/Dr Reddy’s Laboratories’ 120 mg/1 mL denosumab, biosimilar to Amgen’s Xgeva®, in a pre-filled syringe (PFS) with an automatic needle guard.  This new presentation expands Alvotech/Dr Reddy’s denosumab portfolio in India, following the approval of its denosumab vial presentation (120 mg/1.7 mL solution for injection) in August 2017.

The approval is conditional on Dr Reddy’s Laboratories submitting an active post-marketing surveillance study protocol for the approved indications within three months and conducting the study in India and adding product label warnings for patients with phenylketonuria regarding the presence of phenylalanine in the product.

Dr Reddy’s and Alvotech entered into a licence and supply agreement in May 2024 for the commercialisation of AVT03 (denosumab), under which Alvotech develops and manufactures the product and Dr Reddy’s commercialises it exclusively in the US, and semi-exclusively in the EU and UK.

Alvotech also has semi-exclusive commercialisation agreements for European markets with STADA (June 2024) in relation to AVT03.  STADA will market AVT03 as Kefdensis® (referencing Amgen’s Prolia®) and Zvogra® (referencing Xgeva®), while Dr. Reddy’s will market AVT03 as Acvybra® (referencing Prolia®) and Xbonzy® (referencing Xgeva®).

Pearce IP BioBlast® for the week ending 16 October 2026

Oct 20, 2026

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®.  Significant biosimilar activities for the week ending 16 October 2026 are set out below:

Aflibercept

On 14 October 2026, Alvotech and Advanz Pharma announced they have submitted an application to the European Medicines Agency for AVT29, biosimilar to… Read more here.

Nivolumab

On 18 October 2026, the Economic Times reported that Lupin has received marketing approval from India’s Central Drugs Standard Control Organisation (CDSCO)… Read more here.

 

On 13 October 2026, Xbrane Biopharma announced that patient enrolment has completed for a clinical trial of Xdivane™, Xbrane’s biosimilar to BMS’ Opdivo®… Read more here.

Ocrelizumab

On 15 October 2026, Biocad announced that the Russian Ministry of Health has approved biosimilar ocrelizumab (BCD-281) under the name Ocrelizumab Biocad®… Read more here.

Pembrolizumab

On 13 October 2026, Formycon and Zydus Lifesciences announced that the FDA has accepted for review their Biologics Licence Application for FYB206, biosimilar… Read more here.

Pertuzumab

On 14 October 2026, Biocon announced that it has entered a global settlement and licence agreement with Genentech for Pebrilzo® (Bmab 1500), biosimilar to… Read more here.

Ranibizumab, Filgrastim

On 16 October 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its October 2026… Read more here.

About Pearce IP

Pearce IP is a privately owned/independent, specialist, life-sciences focussed, intellectual property/law firm offering lawyers and attorneys in Australia and New Zealand.

Our lawyers and attorneys specialise in pharma, biopharma, biotech, ag-tech, food-tech, med-tech, although our work is broader than these industries.

Pearce IP and its leaders are ranked in every notable legal directory including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, Best Law Firms, among others. In 2025, Pearce IP was honoured by Australasian Lawyer and New Zealand Lawyer as a Top Specialist Firm, 5 Star Employer of Choice, and the “Standout Winner” for Inclusion and Culture (<100 employees).  

Pearce IP is the only leading IP firm in Australia and New Zealand with a female founder, and is certified by WEConnect International as women owned.

 

Naomi Pearce

Naomi Pearce

CEO, Executive Lawyer (AU, NZ), Patent & Trade Mark Attorney (Trans Tasman)

Naomi is the CEO and Founder of Pearce IP, and is one of ANZ’s leading IP practitioners. Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 29 years’ experience, and a background in molecular biology/biochemistry.

Ranked in virtually every notable legal directory, highly regarded by peers and clients, Naomi is renowned for her successful and elegant IP/legal strategies focussing on complex/multijurisdictional litigation, global FTO, and strategic advice.  Among other awards, Naomi is the 2026 Lexology Client Choice Winner for Patents, the 2024 Lawyers Weekly Women in Law “Executive of the Year”, the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology Client Choice Winner for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year”, and the 2021 Lawyers Weekly Women in Law “Partner of the Year”.  Ranked in Chambers Asia Pacific, Chambers Global,  IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks.

Pearce IP is the premier life sciences focussed firm in ANZ.  Commencing in 2017. Pearce IP is the 2025 Australasian Lawyer and NZ Lawyer 5-Star Employer of Choice & “Standout Winner” for Inclusion and Culture (<100 employees).  In 2021, Pearce IP was the Lawyers Weekly Australian Law Awards IP Team of the Year.

Chantal Savage

Chantal Savage

Special Counsel, Lawyer

Chantal is an intellectual property disputes lawyer with experience advising across the spectrum of IP rights, including patents, trade marks, copyright, plant breeder’s rights and trade secrets/confidential information. Recognised as a Rising Star in IP by the Legal 500 Asia Pacific (2021-2024), Chantal has previously worked for international and top tier law firms in Australia and the United Kingdom.

With a science degree specialising in molecular biology and biochemistry, Chantal’s practice focuses particularly on complex, high-value, multi-jurisdictional patent infringement and revocation proceedings for clients in the life sciences sectors.

Maliha Hoque

Maliha Hoque

Paralegal

Maliha is a Paralegal and contributing author to Pearce IP’s flagship circulars BioBlast® and BioGxPulse®.  She is currently completing her Juris Doctor at the University of Sydney.  With a background in medical science, finance and risk consulting, and an inquisitive mind, Maliha loves leaving ‘no stone unturned’ when investigating IP/legal ‘challenges’.  Maliha is interested in the intersection of law and science, and digital transformation.  She gets excited about using her science, business management, and legal skills and experience to support Pearce IP’s lawyers, attorneys and clients.

Samsung Bioepis Enters 10-Year Exclusive Deal to Supply Biosimilar Eculizumab in Brazil

Oct 20, 2026

On 20 October 2026, Samsung Bioepis announced that, in partnership with Brazilian state-owned pharmaceutical laboratory, Bahiafarma, and Brazilian biotechnology company, Bionovis, it has signed an exclusive partnership agreement to supply SB12, biosimilar to Alexion’s Soliris® (eculizumab), to Brazil’s universal public health system.

The agreement is formed under Brazil’s strategic Productive Development Partnership (PDP) framework.  Under the PDP program, Samsung Bioepis will have exclusive access to Brazil’s public healthcare market to supply eculizumab over a 10-year period form 2027.  During this period, Samsung Bioepis will also transfer technology to its local partners, enabling manufacturing in Brazil.

SB12 was approved in Brazil in December 2024 for the treatment of adults and children with PNH and atypical haemolytic uremic syndrome (aHUS).  It was the second eculizumab biosimilar launched in the US (where it is marketed by Teva as Epysqli®) in April 2025, following the launch of Amgen’s Bkemv® in March 2025.  Epysqli® launched in Germany, Italy and Spain in October 2023 and in Korea in April 2024.

Since 2019, Samsung Bioepis has supplied more than 6 million units of its etanercept and trastuzumab biosimilars in Brazil through the PDP program.  In September 2026, Biocon entered into a supply deal with the Brazilian government to supply Bmab 1500, biosimilar to Roche/Genentech’s Perjeta® (pertuzumab) under the PDP program.

Lupin’s Biosimilar to BMS’ Opdivo® (Nivolumab) Approved in India

Oct 18, 2026

On 18 October 2026, the Economic Times reported that Lupin has received marketing approval from India’s Central Drugs Standard Control Organisation (CDSCO) for its nivolumab biosimilar, referencing BMS’ Opdivo®.  No launch plans have been announced to date.

The biosimilar is approved for the same indications as the reference medicine, with the approval subject to Lupin conducting a Phase IV (post-marketing) study in India.  The approval was granted based on positive results from a local Phase III clinical trial, demonstrating comparable pharmacokinetics, efficacy and immunogenicity of the biosimilar with BMS’ Opdivo®.

Lupin will manufacture the biosimilar in partnership with Virchow Biotech, a contract development and manufacturing organisation (CDMO) headquartered in India.

Zydus’ Tishtha® was the first nivolumab biosimilar to be launched in the world when it became available in India in January 2026 (approved July 2024).  This was followed by the Indian launch of the Dr Reddy’s nivolumab biosimilar Nivorz™ in September 2026.

Amgen is the first known company to file an application with the FDA for a biosimilar to BMS’ Opdivo®, having disclosed the US filing of its aBLA for ABP 206 (nivolumab) on 15 September 2026.  Multiple nivolumab biosimilars are under development including Sandoz’s JPB898, Xbrane/Intas’ Xdivane™, Reliance Life Sciences’ RLS-Nivolumab, Enzene’s candidate, and Boan Biotech’s BA1104.

Positive CHMP Opinions for Accord’s Biosimilar Ranibizumab and CuraTeQ’s Biosimilar Filgrastim; Expanded Indications for Novo Nordisk’s Kyinsu® & Janssen’s Talvey®

Oct 16, 2026

On 16 October 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its October 2026 meeting, including positive opinions for two biosimilars and expanded indications for a number of biopharmaceuticals.

Recommended Biosimilars

The CHMP adopted a positive opinion for Accord Healthcare’s biosimilar to Genentech’s Lucentis® (ranibizumab) under the brand name Fovlussea® (10 mg/ml solution for injection).  Accord’s parent company, Intas, received a positive CHMP opinion in April 2026 for another ranibizumab biosimilar brand, Rexatilux®.

Ranibizumab biosimilars already approved and launched in Europe include Samsung Bioepis’ Byooviz® (approved August 2021, commercially available in several European countries since March 2023), STADA/Xbrane’s Ximluci® (launched in the EU in April 2023, following November 2022 approval), Formycon’s Ranivisio® (approved August 2022, being commercialised in the EU by Teva), and Lupin’s Ranluspec® (approved February 2026, commercialised in Europe (excluding Germany) by Sandoz, with planned EU launch in the second half of 2026).  Lupin’s Vislyfa® (ranibizumab) was recommended by the CHMP in May 2026.

The second biosimilar recommended by CHMP in October 2026 is CuraTeQ’s Neuzafy™, biosimilar to Amgen’s Neupogen® (filgrastim).  This is the second biosimilar filgrastim brand for CuraTeQ in Europe, with Zefylti® approved by the European Commission in December 2025.

Recommended Indication Expansions

The CHMP’s October 2026 recommendations for extended indications include:

  • Novo Nordisk’s Kyinsu® (insulin icodec, semaglutide) for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise in addition to oral antidiabetic medicinal products;
  • AstraZeneca’s pandemic influenza vaccine (H5N1) for active immunisation against influenza in an officially declared pandemic situation; and
  • Janssen’s Talvey® (talquetamab) in combination with daratumumab and pomalidomide or in combination with daratumumab, for the treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least one prior therapy.

Genentech and Novartis Commence BPCIA Litigation Regarding Amneal/Kashiv’s Biosimilar Omalizumab

Oct 16, 2026

On 16 October 2026, Genentech and Novartis commenced BPCIA proceedings in the US District Court for the District of Delaware against Amneal Pharmaceuticals and its subsidiary, Kashiv BioSciences, relating to Kashiv’s efforts to bring an omalizumab biosimilar to the US market.

Genentech and Novartis are alleging infringement of 9 US patents relating to antibody manufacturing processes, cell culture media, protein production methods, and the use of anti-IgE antibodies for the treatment of food allergies (12,371,728, 12,371,510, 8,574,869, 11,078,294, 11,987,637, 8,986,957, 9,243,224, 12,030,959 and 12,492,265).

The dispute centres on ADL-018, biosimilar to Genentech/Novartis’ Xolair® (omalizumab), which was developed by Kashiv and licensed to Amneal for exclusive commercialisation in the US.  Amneal announced the submission of its Biologics License Application (BLA) for ADL-018 to the FDA on 26 September 2025, paving the way for regulatory review of the product.

In May 2026, Amneal and Kashiv filed an inter partes review (IPR) petition challenging the validity of US Patent No. 12,030,959, one of the patents in suit in the BPCIA proceedings, which relates to methods of treating food allergies in paediatric patients using omalizumab.  The petition argues that the claimed methods lack novelty and/or are obvious in light of prior clinical trial publications.

Kashiv has entered into agreements for the commercialisation of ADL-018 in other regions, including with CRISTÁLIA for LATAM markets (August 2025), MS Pharma for MENA markets (August 2025) and Alvotech for the EU, UK, Australia, Canada and New Zealand (AVT23, October 2023).  An application for ADL-018 was accepted for review by Health Canada in June 2026 and marketing applications for AVT23 were accepted by the UK’s MHRA in March 2025 and the European Medicines Agency in October 2025.  In September 2026, Alvotech/Advanz Pharma’s Adcomfo® (AVT23/ADL-018) was recommended by the CHMP for approval in 75 mg, 150 mg and 300 mg solution for injection in a pre-filled syringe (PFS) or pre-filled pen (PFP).

Celltrion’s Omlyclo® is currently the only omalizumab biosimilar on the market anywhere in the world.  Omlyclo® was launched in the US in October 2026 (approved March 2025 (75 mg/0.5ml and 150 mg/ml PFS forms) and December 2025 (300mg formulation)).  Celltrion completed its launch of Omlyclo® (75mg and 150mg) in major European countries, including Germany, Spain, the UK and France, in November 2025 and launched the high dose formulation in Europe in August 2026.  In late November 2025, Celltrion announced that it launched Omlyclo® in Brazil.

Teva’s biosimilar omalizumab applications have been accepted for review in the US and EU (March 2026) and CuraTeQ announced Phase 3 study results for its biosimilar omalizumab, BP11, in April 2026.  Mabpharm claims to have had an omalizumab biosimilar (Aomaishu®) approved for marketing in China in May 2023.

First Biosimilar Ocrelizumab Approved in Russia for Biocad

Oct 15, 2026

On 15 October 2026, Biocad announced that the Russian Ministry of Health has approved biosimilar ocrelizumab (BCD-281) under the name Ocrelizumab Biocad® for the treatment of adult patients with active relapsing forms of multiple sclerosis and early primary progressive multiple sclerosis.

The registration of Ocrelizumab Biocad® was based on data from a Phase 3 clinical trial in Russia comparing the biosimilar (BCD-281) with the reference product, Roche’s Ocrevus® (ocrelizumab).  The commencement of the Phase 3 trial was announced in November 2025, following a Phase 1 clinical trial confirming the biosimilarity of BCD-281 with Ocrevus® across all comparable parameters.

According to Biocad, it is estimated that approximately 150,000 people live with multiple sclerosis in Russia, with approximately 80,000 of these receiving treatment with disease modifying drugs.  Biocad expects the release of its biosimilar ocrelizumab to reduce the cost of the therapy by 25%.

Other ocrelizumab biosimilars are in clinical trials sponsored by Sandoz (Phase 3 trial underway, estimated primary completion in November 2026), Amgen (Phase 3 underway, estimated primary completion in 2027), Celltrion (Phase 3 IND for CT-P53 partially approved by the EMA in August 2023, currently recruiting with estimated primary completion in February 2027) and R-Pharm (Phase 1 study commenced April 2025, primary completion in 2026, with estimated completion in November 2027).  In January 2026, Samsung Bioepis announced that it had added an ocrelizumab biosimilar to its pipeline and, in July 2026, Teva and Polpharma entered into an exclusive licensing agreement for the commercialisation of Polpharma’s ocrelizumab biosimilar, PB018.

Biocon Enters Global Settlement with Genentech for Biosimilar Pertuzumab

Oct 14, 2026

On 14 October 2026, Biocon announced that it has entered a global settlement and licence agreement with Genentech for Pebrilzo® (Bmab 1500), biosimilar to Genentech’s Perjeta® (pertuzumab).  The settlement permits Biocon to launch Pebrilzo® in the EU/UK in Q1/2027, in the US in Q3/2028 and in 2026-2028 in other Rest of World countries (or earlier in certain circumstances).

According to Biocon, the agreed launch dates for Pebrilzo® are the earliest licensed launch dates for a pertuzumab biosimilar.  Shanghai Henlius/Organon settled BPCIA proceedings brought by Roche/Genentech in relation to the pertuzumab biosimilar, Poherdy in January 2026, but no licensed launch dates for Poherdy® have been announced.

The Biocon settlement resolves BPCIA proceedings commenced against Biocon by Roche/Genentech in July 2026 in relation to biosimilar pertuzumab.  Roche and Genentech were alleging that Biocon infringes 28 US patents for inventions related to pertuzumab and various manufacturing methods for antibody production, covering pertuzumab as well as its use and manufacture.  The settlement also resolves an ITC complaint filed by Genentech in February 2026 against Biocon’s importation of Bmab 1500 into the US.

Biocon has submitted an abbreviated Biologics License Application (aBLA) to the FDA for approval of Pebrilzo®, the date of filing of which is confidential.  The EMA’s CHMP adopted a positive opinion for Pebrilzo® in September 2026 for the treatment of HER-2 positive breast cancer (420 mg concentrate for solution for infusion).

Shanghai Henlius and Organon had been leading the pertuzumab biosimilar race in major markets, with Poherdy® approvals secured in the US (November 2025), EU (April 2026), and China (as Hanbeiyou®, May 2026).

Approvals for pertuzumab biosimilars have also been granted in India for Intas’ product (December 2024), Zydus’ Sigrima™ (June 2024, subject to ongoing litigation) and Enzene’s Pertuza®/Perzea® (launched September 2025).  In Russia, Biocad’s Pertuvia™ (May 2025, subject to litigation) and R-Pharm’s Persinthia™ (February 2026) are approved.

In June 2026, EirGenix announced that it signed an agreement with an undisclosed company for the licensing and commercialisation of its pertuzumab biosimilar, EG1206A, in Japan.  This followed a 2025 global commercialisation deal with Sandoz for EG1206A, excluding Japan and a number of other countries in Asia.

Alvotech/Advanz Submit First Application for High-Dose Aflibercept Biosimilar

Oct 14, 2026

On 14 October 2026, Alvotech and Advanz Pharma announced they have submitted an application to the European Medicines Agency for AVT29, biosimilar to Regeneron/Bayer’s Eylea® 8 mg (aflibercept), known as Eylea HD™ in the US.  This is the first known regulatory submission anywhere in the world for a high-dose aflibercept biosimilar.

The application was submitted as a line extension to the existing marketing authorisation for Alvotech/Advanz’s Mynzepli®/AVT06 (aflibercept), biosimilar to Regeneron/Bayer’s Eylea®, 2mg.

Alvotech had indicated in March 2026 that it expected to file the first regulatory submission for AVT29 sometime in 2026.  In April 2026, Alvotech commenced a phase 3 clinical trial to evaluate the efficacy and safety of AVT29 compared with Eylea HD® in patients with DME, with an estimated primary completion date of July 2027.

Alvotech and Advanz entered into an agreement in relation to European commercialisation of AVT29 (and AVT06) in June 2024.  Under the agreement, Advanz has exclusive commercialisation rights throughout Europe, except in Germany and France, where it holds semi-exclusive rights.  Teva holds commercialisation rights for AVT29 (and AVT06) in the US.

Amgen is also developing an 8 mg aflibercept biosimilar, ABP 938, and commenced a phase 3 clinical trial in May 2026, with an estimated primary completion date of July 2027.

Beyond the Name. The High Court’s Wake-Up Call for Brand Owners.

Oct 14, 2026

Beyond the name: what brand owners can learn from Bed Bath ’N’ Table Pty Ltd v Global Retail Brands Australia Pty Ltd [2025] HCA 50

A proposed name can look sufficiently different from an existing trade mark and still create a problem when it reaches the market.  Customers encounter more than two names on a page: they see the storefront, packaging, website, products and overall presentation, bringing what they know about existing brands with them.

That distinction sits at the heart of the High Court’s decision in Bed Bath ’N’ Table Pty Ltd v Global Retail Brands Australia Pty Ltd [2025] HCA 50.  It is a useful reminder that clearing a name and clearing a launch are related, but separate, exercises.

What happened?

Bed Bath ’N’ Table (BBNT) had sold soft homewares under its name for more than 40 years.  Global Retail Brands Australia, which operated the established House chain of kitchenware and hard homewares stores, launched a new soft homewares business under the name House Bed & Bath.

The primary judge found that House Bed & Bath was not deceptively similar to BBNT’s registered trade marks for the purpose of trade mark infringement.  The marks differed in important respects, including the prominent “House” element and the distinctive “’N’ TABLE” element in BBNT’s name.  Nevertheless, the judge found that the use of House Bed & Bath as the name and branding of the new stores was misleading or deceptive, or likely to be so, under the Australian Consumer Law (ACL).  The High Court upheld that conclusion, restoring the primary judge’s orders.

How can both findings be right?

Can a brand name avoid trade mark infringement but still mislead consumers?

A brand name may not infringe an existing registered trade mark but may still mislead consumers under the Australian Consumer Law. In Bed Bath ’N’ Table Pty Ltd v Global Retail Brands Australia Pty Ltd [2025] HCA 50, the High Court upheld a finding that the use of House Bed & Bath as the name and branding of new stores was misleading or deceptive, despite the finding that the name was not deceptively similar for the purposes of trade mark infringement.

The trade mark infringement claim asked whether the marks themselves were sufficiently similar to create a likelihood of deception or confusion.  In making that comparison, the court did not give the hypothetical consumer knowledge of BBNT’s actual use of, or reputation in, its registered mark.

The ACL claim asked a different question: what impression was Global Retail Brands’ conduct, viewed as a whole and in its market setting, likely to create for reasonable consumers?  That inquiry could take account of BBNT’s longstanding reputation, the way the respective stores looked, the products they sold and the prominence of “bed” and “bath” on the exterior of BBNT stores over many years.

The potential mistake was not limited to a shopper confusing one name with the other.  A shopper could recognise that House Bed & Bath and Bed Bath ’N’ Table were different names, yet still believe the new stores were connected with BBNT.  The primary judge found that such a mistaken belief in an association was sufficiently likely on these facts.

Why this matters for brand owners?

A favourable comparison of trade marks is an important part of clearance.  It does not, by itself, answer every question about how the proposed brand will be used.  Risk can change as a name moves from an application or shortlist into a shopfront, product range, website or campaign.

The decision does not give an established business ownership of ordinary words appearing in its name.  It turned on an unusual factual setting: BBNT had built a substantial reputation over more than 40 years and, throughout that period, had been the only retailer in Australia using both “bed” and “bath” in its name.  The familiar pairing of those words, in that order, mattered in the market Global Retail Brands was operating.  The evidence also supported findings that Global Retail Brands deliberately sought to benefit from BBNT’s reputation and was willfully blind to the risk of consumer confusion.  Although an intention to deceive was not established, those findings helped the Court assess objectively whether the conduct was likely to mislead.

Three questions to ask before launch?

What should businesses check before launching a new brand?

Businesses should check more than whether a proposed name infringes an existing registered trade mark. They should also consider how the brand will be presented in the marketplace, including store names, signage, packaging, websites and overall branding, and whether this could mislead consumers. In Bed Bath ’N’ Table Pty Ltd v Global Retail Brands Australia Pty Ltd [2025] HCA 50, the High Court upheld a finding of misleading or deceptive conduct under the Australian Consumer Law, despite the finding that the name was not deceptively similar for the purposes of trade mark infringement. To help protect your brand and minimise legal risks, contact Pearce IP for advice before launching.

  • What will customers see together?  Review the proposed name with the packaging, signage, website, product descriptions and visual identity that will accompany it.  Assess the finished customer experience, not just the trade mark application.
  • What connection might they infer?  Consider whether the combined presentation could suggest a brand extension, collaboration, endorsement or other commercial relationship with an established business, even where the names can be told apart.
  • Can the presentation be made more distinct?  If a familiar name or element is commercially important, consider whether the surrounding branding makes the true source of the offering clear.  Revisit that assessment if the product range, channels or campaign change before launch.

The key takeaway

Trade mark clearance should address both the proposed mark and its intended use.  A name may be sufficiently different to avoid infringement, while the broader launch still conveys a misleading impression of commercial association.  Considering the complete presentation early gives a business room to refine its approach before it becomes part of the market.

Pearce IP can assist with the clearance, protection and management of new product and corporate brands in Australia, New Zealand and internationally. Use our Contact Form or email us at info@pearceIP.law or call Australia Tel: +61 (0) 2 9023 9988 or New Zealand Tel: +64 (4) 886 1199.

 

About Pearce IP

Pearce IP is a privately owned/independent, specialist, life-sciences focussed, intellectual property/law firm offering lawyers and attorneys in Australia and New Zealand.

Our lawyers and attorneys specialise in pharma, biopharma, biotech, ag-tech, food-tech, med-tech, although our work is broader than these industries.

Pearce IP and its leaders are ranked in every notable legal directory including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, Best Law Firms, among others. In 2025, Pearce IP was honoured by Australasian Lawyer and New Zealand Lawyer as a Top Specialist Firm, 5 Star Employer of Choice, and the “Standout Winner” for Inclusion and Culture (<100 employees).  

Pearce IP is the only leading IP firm in Australia and New Zealand with a female founder, and is certified by WEConnect International as women owned.

 

Naomi Pearce

Naomi Pearce

CEO, Executive Lawyer (AU, NZ), Patent & Trade Mark Attorney (Trans Tasman)

Naomi is the CEO and Founder of Pearce IP, and is one of ANZ’s leading IP practitioners. Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 29 years’ experience, and a background in molecular biology/biochemistry.

Ranked in virtually every notable legal directory, highly regarded by peers and clients, Naomi is renowned for her successful and elegant IP/legal strategies focussing on complex/multijurisdictional litigation, global FTO, and strategic advice.  Among other awards, Naomi is the 2026 Lexology Client Choice Winner for Patents, the 2024 Lawyers Weekly Women in Law “Executive of the Year”, the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology Client Choice Winner for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year”, and the 2021 Lawyers Weekly Women in Law “Partner of the Year”.  Ranked in Chambers Asia Pacific, Chambers Global,  IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks.

Pearce IP is the premier life sciences focussed firm in ANZ.  Commencing in 2017. Pearce IP is the 2025 Australasian Lawyer and NZ Lawyer 5-Star Employer of Choice & “Standout Winner” for Inclusion and Culture (<100 employees).  In 2021, Pearce IP was the Lawyers Weekly Australian Law Awards IP Team of the Year.

Sarah Ramsey-Caudle

Sarah Ramsey-Caudle

Sarah Ramsey-Caudle is a senior intellectual property lawyer and registered Trans-Tasman Trade Mark Attorney with nearly a decade of experience advising on brand protection, enforcement and commercialisation in Australia, New Zealand and internationally.

Sarah specialises in trade marks and brand protection, including clearance and filing strategies, portfolio management, prosecution, oppositions, non-use proceedings, infringement and enforcement, copyright, licensing and IP commercialisation.

She has advised some of the world’s leading consumer brands, with particular expertise in cosmetics, fashion, retail, food and beverage, and supply chain sectors. Sarah is known for her responsive, commercial and pragmatic approach, providing clear advice aligned with broader business objectives.

Sarah has experience in contentious matters before the Australian Trade Marks Office and Federal Court of Australia. She holds a Master of Intellectual Property Law from the University of Melbourne, a Bachelor of Laws (Honours) and Bachelor of Commerce (International Business) from the University of Adelaide, and is a member of IPSANZ.

Sally Paterson

Sally Paterson

Executive, Lawyer (NZ), Patent & Trade Mark Attorney (AU, NZ)

Sally is a senior Trans-Tasman Patent and Trade Mark Attorney, and a New Zealand registered lawyer with over 20 years’ experience in IP.  Sally’s particular expertise is in life sciences, drawing from her background in biological sciences. Sally is well respected in the New Zealand IP community for her broad ranging skills in all aspects of intellectual property advice, protection and enforcement. Sally has extensive experience securing registration for patents, designs and trade marks in New Zealand, Australia and internationally, providing strategic infringement, validity and enforceability opinions, acting in contentious disputes including matters before the courts of New Zealand and before IPONZ and IP Australia, and advising on copyright and consumer law matters.

Pearce IP BioBlast® for the week ending 9 October 2026

Oct 13, 2026

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®.  Significant biosimilar activities for the week ending 9 October 2026 are set out below:

Pembrolizumab

On 7 October 2026, Halozyme Therapeutics announced that it has won an injunction from the specialised Dutch patent court of the Hague, preventing MSD from… Read more here.
 
On 6 October 2026, Nordic-based Orion Pharma announced that it has entered into a European commercialisation agreement with China-headquartered Qilu Pharma… Read more here.

Ranibizumab

On 8 October 2026, Lupin obtained approval in Australia for three generic ranibizumab products (biosimilars to Novartis’ Lucentis®) under three different brand names… Read more here.

Tocilizumab

On 7 October 2026, Celltrion announced that the FDA has approved an additional indication for its IV formulation of Avtozma® (tocilizumab), biosimilar to Roche/… Read more here.

Ustekinumab

On 6 October 2026, Israel-headquartered biopharmaceutical company Kamada announced the launch of two new biosimilar products in Israel: Ustekinumab-Kamada… Read more here.

Biopharma Deals

On 6 October 2026, Alvotech announced that it has entered into a strategic manufacturing partnership for biosimilars with Lotte Biologics. a contract development and… Read more here.

About Pearce IP

Pearce IP is a privately owned/independent, specialist, life-sciences focussed, intellectual property/law firm offering lawyers and attorneys in Australia and New Zealand.

Our lawyers and attorneys specialise in pharma, biopharma, biotech, ag-tech, food-tech, med-tech, although our work is broader than these industries.

Pearce IP and its leaders are ranked in every notable legal directory including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, Best Law Firms, among others. In 2025, Pearce IP was honoured by Australasian Lawyer and New Zealand Lawyer as a Top Specialist Firm, 5 Star Employer of Choice, and the “Standout Winner” for Inclusion and Culture (<100 employees).  

Pearce IP is the only leading IP firm in Australia and New Zealand with a female founder, and is certified by WEConnect International as women owned.

 

Naomi Pearce

Naomi Pearce

CEO, Executive Lawyer (AU, NZ), Patent & Trade Mark Attorney (Trans Tasman)

Naomi is the CEO and Founder of Pearce IP, and is one of ANZ’s leading IP practitioners. Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 29 years’ experience, and a background in molecular biology/biochemistry.

Ranked in virtually every notable legal directory, highly regarded by peers and clients, Naomi is renowned for her successful and elegant IP/legal strategies focussing on complex/multijurisdictional litigation, global FTO, and strategic advice.  Among other awards, Naomi is the 2026 Lexology Client Choice Winner for Patents, the 2024 Lawyers Weekly Women in Law “Executive of the Year”, the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology Client Choice Winner for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year”, and the 2021 Lawyers Weekly Women in Law “Partner of the Year”.  Ranked in Chambers Asia Pacific, Chambers Global,  IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks.

Pearce IP is the premier life sciences focussed firm in ANZ.  Commencing in 2017. Pearce IP is the 2025 Australasian Lawyer and NZ Lawyer 5-Star Employer of Choice & “Standout Winner” for Inclusion and Culture (<100 employees).  In 2021, Pearce IP was the Lawyers Weekly Australian Law Awards IP Team of the Year.

Chantal Savage

Chantal Savage

Special Counsel, Lawyer

Chantal is an intellectual property disputes lawyer with experience advising across the spectrum of IP rights, including patents, trade marks, copyright, plant breeder’s rights and trade secrets/confidential information. Recognised as a Rising Star in IP by the Legal 500 Asia Pacific (2021-2024), Chantal has previously worked for international and top tier law firms in Australia and the United Kingdom.

With a science degree specialising in molecular biology and biochemistry, Chantal’s practice focuses particularly on complex, high-value, multi-jurisdictional patent infringement and revocation proceedings for clients in the life sciences sectors.

Maliha Hoque

Maliha Hoque

Paralegal

Maliha is a Paralegal and contributing author to Pearce IP’s flagship circulars BioBlast® and BioGxPulse®.  She is currently completing her Juris Doctor at the University of Sydney.  With a background in medical science, finance and risk consulting, and an inquisitive mind, Maliha loves leaving ‘no stone unturned’ when investigating IP/legal ‘challenges’.  Maliha is interested in the intersection of law and science, and digital transformation.  She gets excited about using her science, business management, and legal skills and experience to support Pearce IP’s lawyers, attorneys and clients.

Formycon/Zydus First in Line for Biosimilar Pembrolizumab in US with BLA Accepted for FDA Review

Oct 13, 2026

On 13 October 2026, Formycon and Zydus Lifesciences announced that the FDA has accepted for review their Biologics Licence Application for FYB206, biosimilar to MSD’s Keytruda® (pembrolizumab).  This is the first publicly announced BLA acceptance for a Keytruda® biosimilar in the US.

Zydus had previously expressed optimism that it was well placed to file the first BLA in the US for biosimilar pembrolizumab, following Formycon’s announcement of successful Phase 1 results for FYB206 in February 2026 (the “Dahlia” pharmacokinetic study).  The companies completed clinical development of FYB206 in July 2026 and are relying on a streamlined clinical trial pathway (without a comparative Phase 3 efficacy trial) to accelerate and support the approval of FYB206.

Based on a 12 month FDA review period for the BLA, and a BLA filing date in Q3/2026, a decision on FYB206 is expected in Q3/2027.  A regulatory dossier for FYB206 has also been submitted to Health Canada for approval.

Zydus is commercialising FYB206 in the US and Canada under an exclusive licensing and supply agreement with Formycon entered into in December 2025.  Formycon has entered into separate agreements for commercialisation of FYB206 with MS Pharma for MENA and Lotus for the Asia-Pacific.

Applications for approval of pembrolizumab biosimilars were filed in Korea by Samsung Bioepis (SB27) and Celltrion (CT-P51) in August 2026.  Two months earlier, in June 2026, Samsung Bioepis claimed to be the first developer of a pembrolizumab biosimilar to announce global phase 3 trial results.  Amgen also confirmed on 15 September 2026 that its Keytruda® biosimilar has successfully completed clinical trials with an FDA submission likely later in 2026.

Pembrolizumab biosimilars have reportedly been launched in Paraguay (by Bioeticos in August 2025) and approved in Vietnam (by Biocad in November 2025) and Jordan (by Sana Pharma in February 2026).  Pembrolizumab biosimilars are also in clinical trials including by mAbxience, Sandoz, Bio-Thera, Shanghai Henlius, BioNTech, Qilu Pharmaceutical and Enzene.

Intas/Xbrane Complete Patient Enrolment for Biosimilar Nivolumab Clinical Trial

Oct 13, 2026

On 13 October 2026, Xbrane Biopharma announced that patient enrolment has completed for a clinical trial of Xdivane™, Xbrane’s biosimilar to BMS’ Opdivo® (nivolumab).  The trial is sponsored by Intas, which is jointly developing Xdivane™ with Xbrane under a November 2024 global licensing and co-development agreement.

The streamlined, combined phase 1/3 trial enrolled its first patient in November 2025.  It aims to compare the pharmacokinetics, efficacy, safety and immunogenicity of Xdivane™ versus Opdivo® in 340 patients with resected melanoma.  Xbrane previously reported that the FDA and EMA had both supported the streamlined combined Phase I/3 trial.

Amgen became the first known company to file a US application for an Opdivo® biosimilar, having disclosed the US filing of its aBLA for ABP 206 (nivolumab) on 15 September 2026.  Multiple nivolumab biosimilars are also under development, including Sandoz’s JPB898, , Reliance Life Sciences’ RLS-Nivolumab, Enzene’s candidate, and Boan Biotech’s BA1104.

To date, the only country in which it is reported that nivolumab biosimilars have launched is India, a less regulated market.  The two nivolumab biosimilars launched in India are Zydus’ Tishtha™ (January 2026) and Dr Reddy’s Nivorz® (September 2026).

FDA Finalises Guidance for Post-Approval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products

Oct 13, 2026

On 13 October 2026, the FDA published its final guidance for “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products“ on the Federal Register for industry stakeholders.  This finalises draft guidance which was issued on 23 July 2024, fulfilling a commitment made in the 2022 reauthorisation of the Biosimilar User Fee Act.

The guidance provides manufacturers with non-binding recommendations on the nature and type of information that should be provided to the FDA to support post-approval manufacturing changes of licensed biosimilar and interchangeable biosimilar products.

The FDA considered comments received on the draft and made the following changes when finalising the guidance: “(1) further aligning recommendations in the guidance with the principles in International Council for Harmonisation (ICH) industry guidance entitled “Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process” (ICH Q5E); (2) clarifying recommendations for leveraging comparative analytical assessment data from an original 351(k) biologics license application (BLA); and (3) clarifying edits to Q&A 4 on the nature and type of information that FDA recommends to support approval of a supplement for a dosage form or a strength that has not previously been licensed under the 351(k) BLA.”

Who Owns the Future of Agriculture? The IP Questions Businesses Can’t Afford to Ignore.

Oct 13, 2026

Have your say: help shape our free IP in Agriculture Masterclass

Pearce IP’s life science and bioscience experts are preparing a free, live Masterclass exploring the IP issues shaping the future of agriculture and animal health.


Explore the issues below and vote for the topic you would most like us to cover — or send us your own questions and challenges.

VOTE NOW

From plant genetics and biological breakthroughs to AI, agricultural data and global brands, intellectual property is becoming critical to who controls, commercialises and profits from the next generation of agriculture.

Your next breakthrough could be worth millions.  But who owns it?  Who can commercialise it?  And could a competitor gain access to the data, technology or know-how that gives your business its edge?

As agriculture, agtech, ag-bio, crop protection, food production and animal health evolve, the intellectual property (IP) behind new products, research partnerships and digital platforms is becoming an increasingly important commercial asset — and a potential source of costly disputes, lost opportunities and competitive disadvantage.

A new plant variety might represent decades of breeding and research.  A biological crop protection product might depend on a proprietary formulation and manufacturing process.  An agricultural technology platform might use farm data and AI to generate commercially valuable insights.  An animal health product might emerge from a collaboration involving several organisations across multiple countries.

Each creates potential value.  But without the right strategy, businesses may overlook what can be protected, disclose valuable know-how too soon, misunderstand ownership or grant commercial rights they never intended to give away.

For businesses operating in Australia and New Zealand, or developing products for these markets, IP decisions made today can have lasting consequences.  The question is not simply what your business is developing, but whether you can protect it, control its use and capture its commercial value.

 

PBR vs patents vs trade secrets: have you got the right protection in place?

A new plant variety, genetic trait, biological crop protection product or proprietary breeding technique can represent a significant investment.  But different assets require different protection strategies.

Plant breeders’ rights (PBR) in Australia and plant variety rights (PVR) in New Zealand protect eligible new plant varieties.  Patents may protect eligible inventions, including certain biological products, formulations and technical processes.  Trade secrets can protect confidential know-how, while trade marks help distinguish products and brands in the marketplace.

These protections can work together, but choosing the right approach — and getting the timing right — matters.

Could a competitor reproduce your breakthrough because you chose the wrong protection strategy or disclosed valuable information too soon?  What should you protect, what should you keep confidential, and when should you act?

 

Collaborative IP: who owns the breakthrough?

Agricultural advances rarely happen in isolation.  Universities, researchers, breeders, growers, agtech developers, biotechnology companies and manufacturers often contribute expertise, funding, facilities, biological materials or data.

Collaboration can accelerate development, but it can also create uncertainty over ownership, licensing and commercialisation if IP arrangements are not addressed upfront.

Who owns the resulting IP?  Who can commercialise it?  Can each party use the results independently?  And what happens when the collaboration ends?

Ownership depends on the applicable laws, agreements and circumstances in which the IP was created — not simply who funded the research or employed the researchers.  For trans-Tasman collaborations, businesses should also consider rights and commercial arrangements across Australia, New Zealand and relevant export markets.

When a research partnership succeeds, who gets to benefit from the breakthrough?  And are your agreements ready for that success?

 

Agricultural data sovereignty: who really controls your data?

Modern agriculture generates valuable data through machinery, sensors, drones, satellites, livestock monitoring systems and farm management platforms.  When combined with other datasets, this information can help improve production, predict disease risks and develop new commercial services.

But who controls the information and the value created from it?

Farm data collected through a technology platform may be combined with other information to train predictive models or improve commercial products.  The original data, software and resulting insights may be subject to different rights and contractual arrangements.

The fact that a company collects or stores data does not automatically mean it owns every right in it.  Access, reuse, confidentiality, privacy obligations where applicable and contractual permissions all matter.

Could the data your business generates become someone else’s competitive advantage?  What do your contracts permit, and who benefits when your data helps create new products or services?

 

Agricultural brands and trade marks: are you protecting the value behind your name?

A successful agricultural product is built on more than performance.  Reputation, provenance, consistency and customer trust can all influence purchasing decisions.

Trade marks can help protect the names, logos and other signs that distinguish a business’ goods and services.  But a name available in Australia may conflict with existing rights in New Zealand or an export market.

Businesses should consider trade mark clearance before investing heavily in product development, packaging, marketing or launch campaigns.  Plant breeders must also distinguish between variety names and commercial brands, which serve different purposes.

As businesses expand across borders, overseas registration, licensing and enforcement become increasingly important.

Could an overlooked trade mark conflict delay a launch, complicate an export strategy or force a costly rebrand?  How can you protect the reputation and commercial value you are building?

 

The decisions you make now could shape what comes next

Across agriculture, agtech, ag-bio, crop protection, food production and animal health, scientific advances are creating new opportunities — and new questions about ownership, control and commercialisation.

Businesses need to understand what they own, what they can protect, what they can share and what rights they may be granting to others.  Those questions become particularly important as technologies develop, collaborations expand and products move towards commercialisation.

The future of agriculture will be shaped not only by what businesses discover and develop, but by how effectively they protect and commercialise it.

 

Help shape the discussion

Pearce IP’s life sciences and biosciences experts are preparing a free, live IP in Agriculture Masterclass for businesses operating in Australia and New Zealand.

Which topic matters most to your business? Vote for your preferred topic or send us your questions and suggestions to help shape the Masterclass.

 

 

About Pearce IP

Pearce IP is a privately owned/independent, specialist, life-sciences focussed, intellectual property/law firm offering lawyers and attorneys in Australia and New Zealand.

Our lawyers and attorneys specialise in pharma, biopharma, biotech, ag-tech, food-tech, med-tech, although our work is broader than these industries.

Pearce IP and its leaders are ranked in every notable legal directory including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, Best Law Firms, among others. In 2025, Pearce IP was honoured by Australasian Lawyer and New Zealand Lawyer as a Top Specialist Firm, 5 Star Employer of Choice, and the “Standout Winner” for Inclusion and Culture (<100 employees).  

Pearce IP is the only leading IP firm in Australia and New Zealand with a female founder, and is certified by WEConnect International as women owned.

 

Helen Macpherson

Helen Macpherson

Executive, Lawyer (Head of Litigation –Australia)

Helen is a highly regarded intellectual property specialist and industry leader with more than 25 years’ experience advising on patents, plant breeder’s rights, trade marks, copyright and confidential information. She is known for her expertise in complex, high-value patent matters and leverages her technical background in biochemistry and molecular biology to work across a wide range of technologies, including inorganic, organic, physical and process chemistry, biochemistry, biotechnology (including genetics, molecular biology and virology), and physics. Helen is an active member of the Intellectual Property Committee of the Law Council of Australia and the Intellectual Property Society of Australia and New Zealand.

Paul Johns

Paul Johns

Executive, Lawyer (Head of Litigation – New Zealand)

Paul is an intellectual property dispute resolution specialist with more than 24 years of experience across New Zealand and the UK. Paul is a seasoned lawyer, IP strategist, and Head of Pearce IP’s litigation team in New Zealand.  Paul appears in cases before the New Zealand Court of Appeal and High Court of New Zealand, as well as the New Zealand Intellectual Property Office and IP Australia

Paul is experienced in managing contentious disputes regarding all types of intellectual property and related issues, including patents, copyright, trade marks, designs, confidential information and consumer law. With a background in molecular genetics, Paul has acted for clients across a vast range of industries, including pharmaceuticals, biotechnology, animal health, med-tech, food & beverage technologies, heavy vehicle engineering, fashion, hospitality, and entertainment. Paul is recommended for litigation in the IAM Patent 1000, rated for enforcement and litigation in the WTR1000, ranked for Intellectual Property Asia-Pacific in Chambers, and recognised for Intellectual Property and Litigation in Best Lawyers.

Naomi Pearce

Naomi Pearce

CEO, Executive Lawyer (AU, NZ), Patent & Trade Mark Attorney (Trans Tasman)

Naomi is the CEO and Founder of Pearce IP, and is one of ANZ’s leading IP practitioners. Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 29 years’ experience, and a background in molecular biology/biochemistry.

Ranked in virtually every notable legal directory, highly regarded by peers and clients, Naomi is renowned for her successful and elegant IP/legal strategies focussing on complex/multijurisdictional litigation, global FTO, and strategic advice.  Among other awards, Naomi is the 2026 Lexology Client Choice Winner for Patents, the 2024 Lawyers Weekly Women in Law “Executive of the Year”, the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology Client Choice Winner for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year”, and the 2021 Lawyers Weekly Women in Law “Partner of the Year”.  Ranked in Chambers Asia Pacific, Chambers Global,  IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks.

Pearce IP is the premier life sciences focussed firm in ANZ.  Commencing in 2017. Pearce IP is the 2025 Australasian Lawyer and NZ Lawyer 5-Star Employer of Choice & “Standout Winner” for Inclusion and Culture (<100 employees).  In 2021, Pearce IP was the Lawyers Weekly Australian Law Awards IP Team of the Year.

Pearce IP Australia Ranked for Patent Prosecution in Asia IP 2026 Patent Rankings

Oct 9, 2026

Pearce IP is pleased to announce its inclusion in Asia IP’s 2026 Patent Rankings, with the firm ranked for Patent Prosecution in Australia.

Pearce IP is one of a select list of firms recognised in the Australian Patent Prosecution category, reflecting the firm’s work advising clients on patent strategy, prosecution and portfolio management across Australia and internationally.

The Asia IP Patent Rankings recognise leading intellectual property firms across the Asia-Pacific region.  The rankings are informed by research and feedback from in-house counsel, senior corporate executives and legal professionals.

Feedback from clients of Pearce IP:

“I have always had the impression that their technical expertise goes beyond the expertise of other firms.”

 

“Possibly the best and brightest team on the market”, it is “extremely responsive and helpful”.

Feedback for Naomi Pearce:

“The “fiercely intelligent” Naomi Pearce “combines a unique skill set of being a science qualified lawyer and patent attorney with extensive in-house experience, allowing her to bring to the fore a very client-focused and practical approach… …This is, frankly, gold to clients because they have someone who genuinely understands their commercial needs…”

Peter O-Sullivan, Deputy CEO Pearce IP, says of Sally Paterson and her contribution to Pearce IP’s Australian practice:

“Sally is an exceptional patent prosecution attorney with more than 20 years’ experience and deep expertise across the life sciences.  She combines strong technical knowledge with strategic, commercially focused advice, and has particular expertise in developing and executing patent protection strategies across Australia, New Zealand and internationally.  Sally is highly respected by clients and peers for her technical capability, sound judgement and practical approach.”

The 2026 recognition adds to Pearce IP’s growing recognition across the Australian and Asia-Pacific IP market and reflects the depth of experience of its patent prosecution team.

With presence across Australia and New Zealand, Pearce IP provides comprehensive intellectual property services to local and global clients, supporting life sciences businesses from early R&D through to commercial launch and beyond.

Patents — prosecution, pre-litigation and litigation strategies.

Trade Marks — specialist branding and trade mark strategy.

Plant Breeder’s Rights (PBR) — comprehensive PBR services.

Designs — protection and enforcement of product designs.

Copyright — advice on copyright protection and enforcement.

Commercial IP — licensing, partnering, R&D collaborations and commercialisation strategies.

Regulatory Affairs — aligning commercial, regulatory, clinical and IP strategies.

ASEAN Patent Services — a single Australian-based point of contact for patent filing and prosecution across the ASEAN region.

 

About Pearce IP

Pearce IP is a privately owned/independent, specialist, life-sciences focussed, intellectual property/law firm offering lawyers and attorneys in Australia and New Zealand.

Our lawyers and attorneys specialise in pharma, biopharma, biotech, ag-tech, food-tech, med-tech, although our work is broader than these industries.

Pearce IP and its leaders are ranked in every notable legal directory including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, Best Law Firms, among others. In 2025, Pearce IP was honoured by Australasian Lawyer and New Zealand Lawyer as a Top Specialist Firm, 5 Star Employer of Choice, and the “Standout Winner” for Inclusion and Culture (<100 employees).  

Pearce IP is the only leading IP firm in Australia and New Zealand with a female founder, and is certified by WEConnect International as women owned.

 

Lupin Strives for First to Market Opportunity for Biosimilars to Novartis’ Lucentis® (Ranibizumab) in Australia

Oct 8, 2026

On 8 October 2026, Lupin obtained approval in Australia for three generic ranibizumab products (biosimilars to Novartis’ Lucentis®) under three different brand names, Simulara®, Solentis® and Zivra™.  Each brand is approved in two different formats: 2.3mg/0.23mL solution for injection vial and 1.65mg/0.165 mL solution for injection pre-filled syringe.

Lupin’s wholly owned Australian subsidiary, Generic Health, recently applied for PBS listing of the three brands, with the applications to be considered at the November 2026 PBAC meeting.  Interestingly, Sandoz is the registered owner of the Simulara® trade mark (suggesting that Sandoz may launch one of these biosimilars) and originator Novartis is the registered owner of the Solentis® trade mark in Australia and in some overseas countries (suggesting that perhaps Novartis will seek to cannibalise its own ranibizumab market with the launch of a biosimilar in Australia).  There is no Australian registered trade mark application for Zivra™.

Prior to Lupin’s approvals, there were two ranibizumab biosimilars approved in Australia: Actor Pharmaceuticals’ Raniviz® in 1.65mg/0.165mL PFS (TGA-approved February 2026), and Samsung Bioepis’ Byooviz® 10 mg/mL solution for injection vial (approved August 2022).  No biosimilar product has been launched to date in Australia.  Actor has applied for PBS listing of its biosimilar ranibizumab, with that PBS application also to be considered at the November 2026 PBAC meeting at the same time as Lupin’s.  Despite its approval in 2022, Samsung Bioepis’ Byooviz® is not yet PBS-listed, and there is no suggestion that any PBS application has been made to date.

Pearce IP BioBlast® for the week ending 2 October 2026

Oct 7, 2026

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®.  Significant biosimilar activities for the week ending 2 October 2026 are set out below:

Aflibercept

On 29 September 2026, the Australian Therapeutic Goods Administration (TGA) approved two aflibercept biosimilars sponsored by Actor Pharmaceuticals: Aflivu®… Read more here.

Benralizumab, Canakinumab

On 1 October 2026, Samsung Bioepis and Teva Pharmaceuticals announced a global collaboration and licence agreement to expand their existing partnership for… Read more here.

Denosumab

On 28 September 2026, Teva announced that it has strengthened its position in the biosimilars market with the FDA approval of its internally developed Degevma™… Read more here.

Golimumab

On 30 September 2026, the US District Court for the District of Delaware granted Janssen a preliminary injunction preventing Accord Biopharma and Bio-Thera… Read more here.

Omalizumab

On 6 October 2026, Celltrion announced the US launch of Omlyclo®, biosimilar to Genentech/Novartis’ Xolair® (omalizumab).  Omlyclo® is the first omalizumab… Read more here.

Pembrolizumab

On 30 September 2026, Korea Biomedical Review reported that MSD has launched Keytruda SC™ (pembrolizumab and berahyaluronidase alfa) in Korea and will… Read more here.
 
On 28 September 2026, STADA announced that it has entered into an exclusive partnership with Chia Tai Tianqing Pharmaceutical Group (CTTQ), a subsidiary of… Read more here.

Tocilizumab

On 1 October 2026, Celltrion’s Avtozma® (tocilizumab), biosimilar to Genentech’s Actemra®, became the first tocilizumab biosimilar to be listed on Australia’s Schedule… Read more here.

Biopharma News

On 1 October 2026, Fresenius SE announced that it has completed its acquisition of Spanish-based mAbxience by acquiring the remaining 45% stake in the company… Read more here.
 
On 29 September 2026, Sandoz announced the opening of its new high-volume biosimilar drug substance manufacturing centre in Lendava, Slovenia.  The opening is… Read more here.

About Pearce IP

Pearce IP is a privately owned/independent, specialist, life-sciences focussed, intellectual property/law firm offering lawyers and attorneys in Australia and New Zealand.

Our lawyers and attorneys specialise in pharma, biopharma, biotech, ag-tech, food-tech, med-tech, although our work is broader than these industries.

Pearce IP and its leaders are ranked in every notable legal directory including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, Best Law Firms, among others. In 2025, Pearce IP was honoured by Australasian Lawyer and New Zealand Lawyer as a Top Specialist Firm, 5 Star Employer of Choice, and the “Standout Winner” for Inclusion and Culture (<100 employees).  

Pearce IP is the only leading IP firm in Australia and New Zealand with a female founder, and is certified by WEConnect International as women owned.

 

Naomi Pearce

Naomi Pearce

CEO, Executive Lawyer (AU, NZ), Patent & Trade Mark Attorney (Trans Tasman)

Naomi is the CEO and Founder of Pearce IP, and is one of ANZ’s leading IP practitioners. Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 29 years’ experience, and a background in molecular biology/biochemistry.

Ranked in virtually every notable legal directory, highly regarded by peers and clients, Naomi is renowned for her successful and elegant IP/legal strategies focussing on complex/multijurisdictional litigation, global FTO, and strategic advice.  Among other awards, Naomi is the 2026 Lexology Client Choice Winner for Patents, the 2024 Lawyers Weekly Women in Law “Executive of the Year”, the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology Client Choice Winner for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year”, and the 2021 Lawyers Weekly Women in Law “Partner of the Year”.  Ranked in Chambers Asia Pacific, Chambers Global,  IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks.

Pearce IP is the premier life sciences focussed firm in ANZ.  Commencing in 2017. Pearce IP is the 2025 Australasian Lawyer and NZ Lawyer 5-Star Employer of Choice & “Standout Winner” for Inclusion and Culture (<100 employees).  In 2021, Pearce IP was the Lawyers Weekly Australian Law Awards IP Team of the Year.

Chantal Savage

Chantal Savage

Special Counsel, Lawyer

Chantal is an intellectual property disputes lawyer with experience advising across the spectrum of IP rights, including patents, trade marks, copyright, plant breeder’s rights and trade secrets/confidential information. Recognised as a Rising Star in IP by the Legal 500 Asia Pacific (2021-2024), Chantal has previously worked for international and top tier law firms in Australia and the United Kingdom.

With a science degree specialising in molecular biology and biochemistry, Chantal’s practice focuses particularly on complex, high-value, multi-jurisdictional patent infringement and revocation proceedings for clients in the life sciences sectors.

Maliha Hoque

Maliha Hoque

Paralegal

Maliha is a Paralegal and contributing author to Pearce IP’s flagship circulars BioBlast® and BioGxPulse®.  She is currently completing her Juris Doctor at the University of Sydney.  With a background in medical science, finance and risk consulting, and an inquisitive mind, Maliha loves leaving ‘no stone unturned’ when investigating IP/legal ‘challenges’.  Maliha is interested in the intersection of law and science, and digital transformation.  She gets excited about using her science, business management, and legal skills and experience to support Pearce IP’s lawyers, attorneys and clients.

Palindrome Pharma, a New Biosimilar-Focused Pharmaceutical Company, Launches in Canada

Oct 7, 2026

On 7 October 2026, BioSpace reported that Palindrome Pharma, a new pharmaceutical company focused on biosimilar medicines, has launched in Canada.

Co-founded by the former CEO of Apotex, Dr Jeremy Desai (CEO), and Nitin Kaushal (CFO), the company aims to expand access to high-quality biosimilar medicines through its capabilities in regulatory affairs, market access, medical affairs, commercialisation and support programs.

Desai stated, “biosimilars represent an important opportunity for Canada, and we intend to build a company that earns the trust of our partners through quality, reliability and a long-term commitment to the Canadian market.”

Palindrome plans to work with global and Canadian partners to identify and commercialise biosimilar medicines, guided by patient access, quality and reliability, healthcare sustainability and building transparent and enduring partnerships.

New Indication Alert: Celltrion’s Biosimilar Tocilizumab FDA-Approved for COVID-19 Treatment in Paediatric Patients

Oct 7, 2026

On 7 October 2026, Celltrion announced that the FDA has approved an additional indication for its IV formulation of Avtozma® (tocilizumab), biosimilar to Roche/Genentech’s Actemra®, for the treatment of COVID-19 in paediatric patients aged 2 years and older.  This expands the previous US approved indications for Avtozma®, which included COVID-19 in adults.

Both the intravenous and subcutaneous formulations of Avtozma® were first approved in the US in January 2025, with the IV formulation launched in October 2025.  In August 2025, the FDA approved an additional indication for the IV formulation for the treatment of cytokine release syndrome.  In December 2025, Celltrion secured reimbursement coverage for Avtozma® IV in the US, with patient reimbursement available from January 2026.

Biogen/Bio-Thera’s Tofidence®/BAT1806 (tocilizumab-bavi) was the first US approved tocilizumab biosimilar (IV formulation approved September 2023; launched May 2024), followed by Fresenius Kabi’s Tyenne® (tocilizumab-aazg) (March 2024; IV formulation launched April 2024; SC formulation launched July 2024).

Celltrion’s Avtozma® was the first tocilizumab biosimilar to be approved in Korea in December 2024.  In the same month, Avtozma® received a positive recommendation by the EMA’s CHMP and subsequently gained European Commission approval in February 2025.  The biosimilar has also been granted marketing approval in other regions, including as the first tocilizumab biosimilar approved in Australia (May 2025), Japan (September 2022) and New Zealand (December 2025).  On 1 October 2026, Celltrion’s Avtozma® became the first tocilizumab biosimilar to be listed on Australia’s Schedule of Pharmaceutical Benefits, after being recommended for PBS-listing at the November 2025 PBAC meeting.

MSD’s Subcutaneous Keytruda® Blocked from Launch in 8 European Countries by Halozyme Injunction Win

Oct 7, 2026

On 7 October 2026, Halozyme Therapeutics announced that it has won an injunction from the specialised Dutch patent court of The Hague, preventing MSD from manufacturing, selling, importing and stockpiling Keytruda SC™ (pembrolizumab and berahyaluronidase alfa-pmph) in Belgium, Denmark, France, Ireland, Italy, Sweden, Switzerland and the Netherlands.

The Court ordered the injunction based on its finding that Halozyme’s patent, EP 297 622 (EP 622) is valid and infringed by MSD.  EP 622 relates to modified PH20 hyaluronidase polypeptides and compositions, which Halozyme claims allow for rapid subcutaneous administration of therapeutic drugs.

MSD’s subcutaneous pembrolizumab formulation uses Alteogen’s ALT-B4 technology, a recombinant human hyaluronidase enzyme platform (berahyaluronidase alfa) designed to convert intravenous (IV) drugs into subcutaneous formulations.  Under licensing terms with MSD, Alteogen obtains milestone payments and ongoing commercial royalties linked to Keytruda SC™ sales.  However, according to Korea Economic Daily, Alteogen expects little financial impact from the Dutch court ruling, with the outcome estimated to affect only 3% of Keytruda SC™’s global market.

The final injunction granted by the Dutch Court follows a ruling of the District Court of The Hague in July 2026 dismissing Halozyme’s application for a preliminary injunction to prevent MSD from marketing Keytruda SC™ in Denmark and Sweden pending the outcome of the substantive proceedings.

MSD and Halozyme are also in dispute elsewhere over patents to Halozyme’s MDASE™ subcutaneous delivery technology.  In December 2025, the Munich Regional Court granted a preliminary injunction, preventing MSD from distributing and offering for sale in Germany Keytruda SC™, based on a finding of the Court that there was imminent infringement of EP 622.

In April 2024, Halozyme sued MSD in the US, alleging that MSD’s subcutaneous pembrolizumab (Keytruda Qlex®) infringes 15 patents.  As of 7 October 2026, MSD had successfully invalidated claims of 9 of Halozyme’s US patents before the Patent Trial and Appeal Board (PTAB) and had a further 8 petitions pending before PTAB.

MSD’s subcutaneous pembrolizumab was approved in Europe in November 2025.  It has also been approved in the US as Keytruda Qlex™ (September 2025); in Canada (February 2026), Korea (May 2026, launched September 2026) and Australia (July 2026), as Keytruda SC™; and in Japan as Keyject™ (September 2026).

While there are no reports of biosimilar subcutaneous pembrolizumab development to date, there are multiple pembrolizumab (IV) biosimilars approved or in development.  For example, Samsung Bioepis and Celltrion each applied for Korean approval of their pembrolizumab biosimilars in August 2026 (SB27 and CT-P51, respectively).  In June 2026, Samsung Bioepis claimed to be the first developer of a pembrolizumab biosimilar to announce global phase 3 trial results.  Amgen also confirmed on 15 September 2026 that its Keytruda® biosimilar has successfully completed clinical trials with an FDA submission likely later this year.  Formycon announced successful Phase 1 results in February 2026, with its US commercialisation partner, Zydus, expressing optimism that it is well-placed to file the first BLA in the US for biosimilar pembrolizumab.

Product specific reports based on extracts from our BioBlast® database

adalimumab | Humira® | AbbVie

aflibercept | Eylea® | Regeneron

bevacizumab | Avastin® | Roche/Genentech

cetuximab | Erbitux® | Eli Lilly/Merck KGaA

daratumumab | Darzalex® | J&J

darbepoetin | Aranesp® | Amgen

denosumab | Prolia®/Xgeva® | Amgen

dupilumab | Dupixent® | Sanofi-Aventis

eculizumab | Soliris® | Alexion

etanercept | Enbrel® | Amgen

faricimab | Vabysmo® | Roche

filgrastim (GCSF) | Neupogen® | Amgen

golimumab | Simponi® | Janssen

guselkumab | Tremfya® | Janssen

infliximab | Remicade® | Johnson & Johnson

ixekizumab | Taltz® | Eli Lilly

lecanemab | Leqembi® | Eisai/Biogen

liraglutide | Victoza® /Saxenda® | Novo Nordisk

natalizumab | Tysabri® | Biogen/Elan

nivolumab | Opdivo® | BMS

olaparib | Lynparza® | AstraZeneca/Merck

omalizumab | Xolair® | Genentech / Novartis

pegfilgrastim | Neulasta® | Amgen

pembrolizumab | Keytruda® | MSD

pertuzumab | Perjeta® | Roche

ranibizumab | Lucentis® | Genentech

regdanvimab | Regkirona® | Celltrion

risankizumab | Skyrizi® | AbbVie

rituximab | Rituxan®/MabThera® | Genentech/Biogen

secukinumab | Cosentyx® | Novartis

semaglutide | Wegovy®/Ozempic® | Novo Nordisk

tocilizumab | Actemra® | Roche

trastuzumab | Herceptin® | Roche/Genentech

ustekinumab | Stelara® | Johnson & Johnson/Janssen

vedolizumab | Entyvio® | Takeda

View latest BioBlast® updates

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BioBlast® Editor and Contributing Author

Naomi Pearce & Emily Bristow

Naomi Pearce & Emily Bristow

Editor: Naomi Pearce, Executive Lawyer, Patent Attorney & Trade Mark Attorney
Contributing Author: Emily Bristow, Law Graduate

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