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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.

Celltrion’s Truxima® Becomes First Interchangeable Rituximab Biosimilar in US

On 1 July 2026, Celltrion announced that the FDA has granted interchangeability status to Truxima®, biosimilar to Genentech/Biogen’s Rituxan®, making it the first rituximab biosimilar in the US to earn this designation.  As the first interchangeable rituximab biosimilar in the US, Truxima® has a 1-year exclusivity period, during which the FDA cannot approve subsequent interchangeable versions of Rituxan®.

Truxima® was launched in the US in May 2020 and is approved for all non-paediatric indications of Rituxan®, including non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and microscopic polyangiitis.

Rituxan® was first approved in the US on 26 November 1997 and was one of the first mAbs to become biosimilar.  In addition to Truxima®, Amgen/Allergan’s Riabni® (approved December 2020) and Pfizer’s Ruxience® (launched January 2020) are the only rituximab biosimilars approved in the US market, with Dr Reddy’s biosimilar rituximab being knocked back by the FDA in April 2024.

Samsung Bioepis/Harrow Relaunch Ranibizumab Biosimilar in US

On 1 July 2026, Samsung Bioepis and Harrow announced the relaunch of Byooviz® (ranibizumab), biosimilar to Genentech’s Lucentis®, in the US.

The relaunch follows the transition of Biogen’s commercialisation rights for biosimilar ranibizumab (and biosimilar aflibercept) back to Samsung Bioepis after Biogen terminated a November 2019 agreement with Samsung Bioepis for the US and Canada.  Samsung Bioepis entered into a partnership with Harrow in July 2025 for the US commercialisation of Byooviz® (and Opuviz® (aflibercept)) on full return of the commercial rights.

Byooviz® was approved in the US in September 2021 for the treatment of patients with neovascular (wet) age-related macular degeneration, macular oedema following retinal vein occlusion, and myopic choroidal neovascularisation.  It was originally launched in the US in June 2022 and was granted interchangeability designation by the FDA in October 2023.

The following ranibizumab biosimilars are also approved in the US: Sandoz’s Cimerli® (August 2022, rights acquired by Sandoz from Coherus in March 2024), Formycon’s Nufymco® (December 2025) and Lupin’s Ranluspec® (June 2026).

Celltrion Launches Omalizumab Autoinjector in Korea

On 1 July 2026, Seoul Economic Daily reported that Celltrion has launched its new Omlyclo® (omalizumab) Pen Injection 150mg, an autoinjector formulation designed for the treatment of allergic asthma and chronic idiopathic urticaria.

Celltrion announced the Korean approval of the autoinjector presentation of Omlyclo®, biosimilar to Novartis’ Xolair®, in December 2025.  The launch comes three months after Celltrion’s Korean launch of its high dose (300 mg) Omlyclo® formulation.

Celltrion’s Omlyclo® (CT-P39) is currently the only omalizumab biosimilar on the market anywhere in the world. Omlyclo® was approved in the US in March 2025 (75 mg/0.5ml and 150 mg/ml PFS forms) and in December 2025 (300mg formulation).  Celltrion commenced its European rollout of Omlyclo® with the launch of the product in Norway in September 2025, and completed its launch in major European countries including Germany, Spain, the UK and France in November 2025.  In late November 2025, Celltrion announced that it launched Omlyclo® in Brazil, while in January 2026, high dose Omlyclo® (PFS and autoinjector) was approved in Canada.

Kashiv BioSciences/Alvotech are likely to be the next companies with an approved omalizumab biosimilar on the market.  Under an exclusive licensing agreement with Kashiv entered in October 2023, Alvotech holds the commercialisation rights to ADL-018 (also referred to as AVT23) in Canada, together with the European Economic Area, UK, Switzerland, Australia and New Zealand.  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 by the European Medicines Agency in October 2025.  Kashiv has entered into agreements for commercialisation of ADL-018 with Cristália for LATAM (August 2025) and MS Pharma for MENA markets (August 2025).

Omalizumab biosimilars are also in development by at least CuraTeQ (Ph 3 study results announced April 2026) and Teva (acceptance for review of biosimilar omalizumab applications in US and EU announced March 2026).

Pearce IP BioBlast® for the week ending 26 June 2026

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 26 June 2026 are set out below:


Denosumab

On 23 June 2026, Organon and Shanghai Henlius announced the Canadian launch of Bildyos® (denosumab injection, 60 mg/1 mL) and Tuzemty® (denosumab injection… Read more here.

Denosumab, Pegfilgrastim, Ustekinumab

On 26 June 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its June 2026 meeting, including positive… Read more here.

Golimumab

On 19 June 2026, Janssen filed a BPCIA complaint against Alvotech in the US District Court for the Eastern District of Virginia alleging that Alvotech’s golimumab biosimilars, AVT05 SC… Read more here.

Pembrolizumab

On 25 June 2026, MSD announced that the FDA has approved each of Keytruda® (pembrolizumab) and Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph), in… Read more here.

Vusolimogene oderparepvec

On 26 June 2026, Replimune announced that its third submission of the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with BMS’ Opdivo®… Read more here.

Biopharma News

On 22 June 2026, AbbVie and Apogee Therapeutics announced that they have entered into a definitive agreement for the acquisition by AbbVie of all outstanding shares of Apogee… 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 LawExecutive 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 1000IAM 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.

EirGenix Signs Agreement for Commercialisation of Pertuzumab Biosimilar in Japan

On 30 June 2026, EirGenix announced that it has signed an agreement for the licensing and commercialisation of EG1206A, biosimilar to Roche’s Perjeta® (pertuzumab), in Japan.  The partner to the deal has not been identified but is said to be a “leading Japanese pharmaceutical company”.

Under the agreement, EirGenix will provide CMC-related know-how and product-related information necessary for regulatory activities, while remaining responsible for product development, manufacturing, and commercial supply.  The Japanese partner will lead regulatory approval activities and commercialisation in Japan.

According to EirGenix, a pharmacokinetic clinical study for EG1206A has been completed and the biosimilar has received positive feedback from both the FDA and the European Medicines Agency regarding the feasibility of an abbreviated development pathway, including the waiver of Phase 3 comparative efficacy trials.

In 2025, EirGenix entered into a global commercialisation deal with Sandoz for EG1206A which excluded Japan and a number of other countries in Asia.  This followed a 2023 deal between the same companies relating to EirGenix’s trastuzumab biosimilar Herwenda® (referencing Genentech’s Herceptin®).

Henlius and Organon are leading the pertuzumab biosimilar race in major markets, with approvals of Poherdy® secured in the US, EU, and China (as Hanbeiyou®).  Approvals for pertuzumab biosimilars have been granted in India for Intas’ product (December 2024), Zydus’ Sigrima™ (June 2024subject to ongoing litigation) and Enzene’s Pertuza®/Perzea® (launched September 2025).  In Russia, Biocad’s Pertuvia™ (May 2025) and R-Pharm’s Persinthia™ (February 2026) are approved.

Orion Pharma Partners with Shilpa for Biosimilar Nivolumab in Europe

On 30 June 2026, Nordic-based Orion Pharma announced it has entered into an agreement with India-headquartered Shilpa Biologicals, a subsidiary of Shilpa Medicare, to commercialise in Europe Shilpa’s intravenous nivolumab biosimilar, which is currently under development.

Under the agreement, Orion will have the exclusive right to distribute, market and sell Shilpa’s biosimilar nivolumab in Europe, while Shilpa will supply the product to Orion and is entitled to receive certain confidential development and regulatory milestone payments.

BMS’ originator nivolumab (Opdivo®) is approved in Europe for various indications including:

A number of other nivolumab biosimilars are under development including Sandoz’s JPB898, Xbrane/Intas’ Xdivane™, Amgen’s ABP 206, Reliance Life Sciences’ RLS-Nivolumab, Enzene’s candidate, Boan Biotech’s BA1104, NeuClone’s candidate and Zydus’ ZRCr-4276.

Orion has an existing distribution agreement for Europe with CuraTeQ in relation to unidentified biosimilars, while Shilpa announced a commercialisation deal with SteinCares for an undisclosed biosimilar in Latin America in February 2026.

Strengthening Our Trade Marks Capability | Sarah Ramsey-Caudle Joins Pearce IP

Pearce IP continues to deliver on its commitment to set the standard for excellence in the provision of legal and intellectual property services across Australia and New Zealand with the appointment of Sarah Ramsey-Caudle as Senior Associate, Lawyer & Trade Mark Attorney.

Sarah joins Pearce IP with nearly a decade of experience advising Australian, New Zealand and international clients on the protection, enforcement and commercialisation of brands.  She advises on all aspects of trade mark law, from clearance and filing strategies through to portfolio management, prosecution, oppositions, non-use proceedings, infringement disputes, enforcement actions, copyright, licensing and intellectual property commercialisation.  Sarah regularly manages Australian and international trade mark portfolios and has experience in contentious matters before the Australian Trade Marks Office and the Federal Court of Australia, combining technical expertise with commercially focused advice to help clients build, protect and maximise the value of their intellectual property.

Having worked with some of the world’s most recognised consumer brands, Sarah has particular expertise advising clients in the cosmetics, fashion, retail, food and beverage, and supply chain sectors.  She is known for providing responsive, pragmatic advice that aligns intellectual property strategies with broader business objectives.

Commenting on Sarah’s appointment, Pearce IP CEO & Founder, Executive Lawyer (AU, NZ), Patent Attorney (AU, NZ) & Trade Mark Attorney (AU), Naomi Pearce, said:

“We are delighted to welcome Sarah to Pearce IP. She brings exceptional technical expertise, extensive experience managing valuable brand portfolios, and a practical commercial approach that aligns perfectly with how we support our clients.  Sarah’s appointment reflects our continued investment in providing market-leading trade mark expertise across Australia and New Zealand.”

Sarah Ramsey-Caudle said:

“Trade marks are one of a business’ most valuable assets because they are how customers recognise, connect with and trust a brand.  Helping businesses protect and capitalise on those assets is what makes working in this area so dynamic and rewarding.  I’m delighted to join Pearce IP and work alongside a team recognised for its specialist expertise and commitment to delivering exceptional service and outcomes for our clients.  I look forward to partnering with clients to help them build, protect and maximise the value of their brands through practical, commercially focused IP strategies.”

To learn more about Sarah and her experience, view her profile or contact her directly at sarah.ramseycaudle@pearceIP.law.


 

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.

 

Apotex Secures First Canadian-Approved Generic Semaglutide for Weight Loss

On 29 June 2026, Health Canada approved Apotex’s Sevmia™, generic equivalent of Novo Nordisk’s Wegovy® (semaglutide).  Sevmia™ is the first generic semaglutide product approved in Canada for chronic weight management.

Sevmia™ was developed in partnership with Orbicular Pharmaceutical Technologies and is approved as a solution for subcutaneous injection in a pre-filled pen (4 mg/pen; 1.34 mg/mL).  It is indicated for once-weekly treatment of patients aged 12 years and over, as a supplement to a reduced calorie diet and increased physical acitivity for chronic weight management.

Generic semaglutide products have previously been approved in Canada only for the treatment of type 2 diabetes.  Apotex’s Apo-Semaglutide Injection™ was approved on 1 May 2026 and launched 14 May 2026, while Dr Reddy’s Laboratories’ generic semaglutide injection was approved on 29 April 2026 and also launched in Canada on 14 May 2026.

Health Canada is reviewing numerous submissions for generic semaglutide, including applications by AA Pharma, Aspen Pharmacare, Teva, Taro Pharmaceuticals, Zydus Lifesciences and Sandoz (which is planning a 2026 generic semaglutide launch in Canada).  Further generic semaglutide approvals and launches are therefore expected in Canada in the coming months.

Samsung Bioepis Announces Positive Results from Global Ph 1/3 Biosimilar Pembrolizumab Studies

On 29 June 2026, Samsung Bioepis announced positive results from global Phase 1 and Phase 3 clinical trials, confirming equivalence of SB27 (pembrolizumab) with the reference product, MSD’s Keytruda®.  According to Samsung Bioepis, it is the first developer of a pembrolizumab biosimilar to announce global phase 3 clinical trial results.

The news follows reports published on 5 May 2026 announcing positive preliminary Phase 1 data for SB27, which were subsequently withdrawn from a number of news sites.  The Phase 1 and Phase 3 trials were both commenced in 2024, in an “overlap strategy” designed to accelerate SB27 development, with the studies expected to be completed by the end of 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).

There are multiple pembrolizumab biosimilars in development.  Formycon’s FYB206 demonstrated pharmacokinetic bioequivalence with Keytruda® in the Phase 1 “Dahlia” study (reported in February 2026).  Formycon’s US commercialisation partner, Zydus, has previously expressed optimism that it is well-placed to file the first BLA in the US for biosimilar pembrolizumab.  Formycon has also announced agreements for commercialisation of pembrolizumab biosimilar FYB206 with MS Pharma for the MENA region, and Lotus for the Asia-Pacific.

Other companies with pembrolizumab biosimilars in clinical trials include Amgen, mAbxience, Sandoz, Celltrion, Bio-Thera, Shanghai Henlius, BioNTech, Qilu Pharmaceutical and Enzene.  Alvotech and Dr Reddy’s have entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a Keytruda® biosimilar and Bio-Thera and Avalon are partnering on commercialisation of a pembrolizumab biosimilar (BAT3306) in Saudi Arabia/MENA.

Replimune’s Third Submission for Vusolimogene Oderparepvec Plus Nivolumab Accepted for Review by FDA

On 26 June 2026, Replimune announced that its third submission of the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with BMS’ Opdivo® (nivolumab) for the treatment of advanced melanoma has been accepted for review by the FDA.  A target date for the FDA’s decision has been set for 2 August 2026.

Replimune’s plan for resubmission was reported in May 2026, following the rejection of two earlier submissions in July 2025 (first Complete Response Letter (CRL) issued in response to a November 2024 BLA submission) and April 2026 (second CRL issued in response to an October 2025 BLA submission).

In May 2026, the FDA indicated it would treat Replimume’s BLA resubmission as an urgent matter upon receipt and would prioritise its review in recognition of the significant unmet need for patients in the advanced melanoma community.

CHMP Positive Opinions for Ascend’s Biosimilar Denosumab & Qilu Pharma’s Biosimilar Pegfilgrastim; Extended Indications Including for Janssen’s Ustekinumab

On 26 June 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its June 2026 meeting, including positive opinions for two biosimilars and recommended indication extensions for a number of biopharmaceuticals.

Ascend GmbH (a subsidiary of Alkem Laboratories) secured a CHMP positive opinion for “Denosumab Ascend”, biosimilar to Amgen’s Xgeva® (denosumab).  In November 2025, Alkem’s subsidiary, Enzene, received a CHMP positive opinion for Osqay®, biosimilar to Amgen’s Prolia® (denosumab).  Enzene and Theramex entered into an agreement in 2021 under which Enzene will supply Theramex with its denosumab biosimilar for commercialisation in Europe, the UK, Switzerland and Australia.  Alkem and Ascend are currently parties to BPCIA litigation commenced by Amgen in November 2025 following the filing of Alkem/Ascend’s BLA for biosimilar denosumab in the US.

The second biosimilar to be recommended by CHMP at its June 2026 meeting was Qilu Pharma’s Nylaspeg™, biosimilar to Amgen’s Neulasta® (pegfilgrastim).  The recommendation comes over 7 years after the approval of the first European pegfilgrastim biosimilar, Accord Healthcare’s Pelgraz®, in September 2018.

CHMP’s June 2026 positive opinions for extended indications include:

  • Janssen’s Stelara® (ustekinumab) for the treatment of moderately to severely active ulcerative colitis in paediatric patients from the age of 2 years and older, who have had an inadequate response to, or were intolerant to either conventional therapy or a biologic.
  • AstraZeneca/Daiichi Sankyo’s Datroway® (datopotamab deruxtecan) as a monotherapy, for the first-line treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy; and
  • Janssen’s Tecvayli® (teclistamab) in combination with daratumumab for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior therapy.

New Indication Alert: MSD’s Pembrolizumab Approved for New Indications & Combinations in US & EU

On 25 June 2026, MSD announced that the FDA has approved each of Keytruda® (pembrolizumab) and Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph), in combination with Gilead’s Trodelvy® (sacituzumab govitecan-hziy) for the first-line treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours express PD-L1 (Combined Positive Score [CPS] ≥10) as determined by an FDA-authorised test.  According to the announcement, these approvals represent the first regimen of a PD-1 inhibitor plus Trop-2 directed antibody-drug conjugate (ADC) in advanced TNBC.

The US approvals came a day after it was announced that Keytruda® was approved in Europe, in combination with Astellas’ Padcev™ (enfortumab vedotin), as neoadjuvant treatment (before surgery) and then continued after radical cystectomy (surgery) as adjuvant treatment, for adults with resectable muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy in the EU.

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).

There are multiple pembrolizumab biosimilars in development.  Formycon’s FYB206 appears to be the front runner, having demonstrated pharmacokinetic bioequivalence with Keytruda® in its “Dahlia” study (reported in February 2026).  Formycon’s US commercialisation partner, Zydus, has expressed optimism that it is well-placed to file the first BLA in the US for biosimilar pembrolizumab.  Formycon has also announced agreements for commercialisation of pembrolizumab biosimilar FYB206 with MS Pharma for the MENA region, and Lotus for the Asia-Pacific.

Other companies with pembrolizumab biosimilars in clinical trials include Samsung Bioepis, Amgen, mAbxience, Sandoz, Celltrion, Bio-Thera, Shanghai Henlius, BioNTech, Qilu Pharmaceutical and Enzene.  Alvotech and Dr Reddy’s have entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a Keytruda® biosimilar and Bio-Thera and Avalon are partnering on commercialisation of a pembrolizumab biosimilar (BAT3306) in Saudi Arabia/MENA.

4 Pearce IP Patent Professionals Honoured In Managing IP’S IP STARS 2026

4 of Pearce IP’s patent professionals have been recognised in Managing IP’s IP STARS 2026, one of the world’s leading guides to IP firms and practitioners.

This year’s individual recognitions include:

These individual accolades follow the firm’s 2026 IP Stars rankings for Patent Disputes, Patent Prosecution, and Trade Mark Prosecution.

Naomi Pearce, Founder and CEO, says;

“These rankings are a testament not only to the calibre of our professionals and leaders, but also to the collaborative culture and high standards that define Pearce IP.  I am honoured to work alongside such dedicated practitioners and congratulate them on this achievement.”

We extend our sincere thanks to our clients, colleagues and peers for their continued trust and support.  Congratulations to Naomi, Helen, Jacinta, and Paul on this well-deserved recognition.


 

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.

 

MIP IP STARS 2026 Ranks Pearce IP for Patent Litigation, Patent Prosecution and Trade Mark Prosecution in Australia and New Zealand

Pearce IP has been ranked by Managing IP in the 2026 Asia-Pacific IP Stars for Patent Prosecution, Patent Disputes and Trade Mark Prosecution, marking the sixth consecutive year of rankings for the Australian office and the first for Pearce IP New Zealand which was founded in 2024.

In Australia, Pearce IP is ranked by MIP in 2026 for
Patent Prosecution,
Patent Disputes, and
Trade Mark – Patent & Trade Mark Attorney Firms.

In New Zealand, Pearce IP is ranked by MIP in 2026 for
Trade Mark Prosecution.

In addition, 4 of Pearce IP’s leaders and team members have been ranked among the leading IP practitioners in ANZ.

MIP IP STARS is recognised as a leading benchmark of excellence in the global IP profession.

Deputy CEO & Head of People & Culture at Pearce IP, Peter O’Sullivan, who joined Pearce IP in May says;

“What has impressed me most since joining Pearce IP is the calibre of our people and the genuine commitment across the firm to delivering exceptional client outcomes. These rankings reflect a culture built on collaboration, accountability and continuous improvement.

 

To see that recognised across multiple practice areas and jurisdictions is a significant achievement and speaks to the strength of the team and the foundation that has been built under Naomi’s leadership.”

Pearce IP Founder and CEO, Naomi Pearce, said the rankings recognise the firm’s continued focus on delivering exceptional outcomes for clients, across APAC;

“We are unapologetic in delivering to our 2027 Vision to be the premier life sciences IP/legal firm in Australia and New Zealand, and remain focused on providing world-class service and outstanding results for our clients.

 

Thank you to our clients for your ongoing support, and congratulations to every member of the Pearce IP team on this achievement.”


 

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.

 

Pearce IP BioBlast® for the week ending 19 June 2026

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 19 June 2026 are set out below:


Aflibercept

On 19 June 2026, The Asia Business Daily reported that Alteogen Biologics’ MENA region partner, SPIMACO, has received product approval for ALT-L9 (aflibercept), biosimilar to… Read more here.

Bevacizumab

On 16 June 2026, Outlook Therapeutics announced that its resubmitted Biologics License Application (BLA) for ONS-5010/Lytenava™ (bevacizumab-vikg) has been accepted for… Read more here.

Dupilumab

On 18 June 2026, Korea Biomed reported that South Korean-headquartered Alteogen has disclosed in an investor communication that a non-exclusive licence agreement it… Read more here.

Secukinumab

On 18 June 2026, CSPC Pharmaceutical Group announced that China’s National Medical Products Administration (NMPA) has accepted its marketing authorisation application… Read more here.

Ustekinumab

On 18 June 2026, Samsung Bioepis and Organon announced the expansion of their development and commercialisation agreement for Canada to include Samsung Bioepis’… Read more here.

Biopharma News

On 17 June 2026, Sandoz announced the opening of its new biosimilar development centre in Ljubljana, Slovenia.  The construction of the fully digitally integrated USD 99 million… 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 LawExecutive 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 1000IAM 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.

Organon & Shanghai Henlius Launch Denosumab Biosimilars in Canada

On 23 June 2026, Organon and Shanghai Henlius announced the Canadian launch of Bildyos® (denosumab injection, 60 mg/1 mL) and Tuzemty® (denosumab injection, 120 mg/1.7 mL), indicated for all approved reference indications of Amgen’s Prolia® and Xgeva®, respectively.

Bildyos® and Tuzemty® (HLX14) were approved in Canada in March 2026.  Organon was granted the exclusive commercialisation rights to Henlius’ denosumab biosimilars globally, “except for China; including Hong Kong, Macau and Taiwan”, under a June 2022 agreement.

Henlius/Organon have previously launched denosumab biosimilars in the US under the names Bildyos® and Bilprevda® (approved September 2025, launched October 2025).  Bildyos® and Bilprevda® were approved in the EU in September 2025.

Sandoz’s Wyost® (February 2024) and Jubbonti® (March 2024) were the first denosumab biosimilars approved in Canada, and were launched in August 2024.  This was followed by the Canadian approvals of Celltrion’s Stoboclo® and Osenvelt® (September 2025), Apotex’s Denoza™, biosimilar to Amgen’s Prolia®, (April 2026) and Biocon’s Bosaya™ and Vevzuo™ (April 2026).

AbbVie to Acquire US-Based Apogee Therapeutics in USD10.9B Deal

On 22 June 2026, AbbVie and Apogee Therapeutics announced that they have entered into a definitive agreement for the acquisition by AbbVie of all outstanding shares of Apogee Therapeutics in an all-cash transaction valued at approximately USD$10.9 billion ($135.11 per share).

The transaction is expected to close in Q3/2026, subject to closing conditions including Apogee shareholder approval and receipt of regulatory approvals.

According to the companies, the acquisition of Apogee “holds potential for substantial shareholder value creation with mega-blockbuster peak sales potential across Apogee’s pipeline of assets”.

Apogee’s pipeline of assets includes zumilokibart (APG777) for the treatment of inflammatory diseases, including atopic dermatitis and asthma.  Zumilokibart is a subcutaneous antibody that is being positioned as a competitor to Eli Lilly’s Ebglyss® (lebrikizumab) and Regeneron/Sanofi’s Dupixent® (dupilumab).  In the Phase II clinical trial, zumilokibart demonstrated strong efficacy and a safety profile consistent with other medicines in its class.  Phase III trials are set to commence in 2026, with an anticipated commercial launch in 2029.

The acquisition of Apogee complements AbbVie’s current immunology portfolio, which includes Humira® (adalimumab), Skyrizi® (risankizumab) and Rinvoq® (upadacitinib) and generated $7.29 billion in the first quarter of 2026.

Janssen Commences BPCIA Litigation Against Alvotech for Biosimilar Golimumab

On 19 June 2026, Janssen filed a BPCIA complaint against Alvotech in the US District Court for the Eastern District of Virginia alleging that Alvotech’s golimumab biosimilars, AVT05 SC and IV, infringe 14 Janssen patents relating to Simponi® (SC), Simponi Aria® (IV) and the manufacture and delivery of biologic products like golimumab.

The proceedings follow 2 weeks after Alvotech announced on 4 June 2026 that it had resubmitted its AVT05 BLA to the FDA.  Janssen alleges that by submitting its BLA for AVT05 SC and AVT05 IV and “taking concrete steps to market those products, Alvotech has infringed, and threatens to infringe, Janssen’s patents”.

Alvotech’s BLA for AVT05 was first accepted for review by the FDA in January 2025.  Alvotech received a Complete Response Letter from the FDA in November 2025 and subsequently undertook a “remediation project”.  The golimumab BLA was then resubmitted following completion of an FDA “routine cGMP surveillance inspection” of Alvotech’s Reykjavik manufacturing facility in May 2026 and the provision by Alvotech of responses to observations raised as a result of that inspection.  AVT05 will be commercialised in the US by Teva under an August 2020 strategic partnership.

The litigation against Alvotech is the second BPCIA proceeding regarding golimumab commenced by Janssen, following a complaint filed against Bio-Thera Solutions and Accord BioPharma in March 2026.  That complaint alleges that Bio-Thera/Accord’s golimumab biosimilars (Immgolis™ and Immgolis Intri™ (BAT2506)), the first and only golimumab biosimilars to have been FDA-approved (May 2026), infringe 17 Janssen patents.

AVT05 was the first golimumab biosimilar to be approved worldwide in September 2025, with its approval in Japan as Gobivaz®.  Gobivaz® received a positive CHMP opinion from the EMA in September 2025, followed by approval in Europe and the UK in November 2025, where it is commercialised by Advanz Pharma.

New Indication Alert: Chugai Secures New Indications in Japan for Rituximab and Bevacizumab

On 19 June 2026, Chugai Pharmaceutical (a Roche subsidiary) announced that the Japanese Ministry of Health, Labour and Welfare has approved Rituxan® (rituximab) for adult-onset frequently relapsing or steroid-dependent nephrotic syndrome, and Avastin® (bevacizumab) for treatment of neurofibromatosis type 2.  Avastin® is now the first drug approved in the world for the treatment of neurofibromatosis type 2.

Rituxan® was approved in Japan in August 2014 for paediatric-onset refractory nephrotic syndrome (frequently relapsing or steroid-dependent), in September 2024 for steroid-resistant paediatric-onset refractory nephrotic syndrome, and in March 2025 for paediatric-onset non-refractory frequently relapsing or steroid-dependent nephrotic syndrome.

Chugai currently co-promotes Rituxan® in Japan with Zenyaku Kogyo, which is the marketing authorisation holder.  However, in April 2026, Chugai and Zenyaku announced that they have terminated their co-promotion in Japan for Rituxan®, effective from 3 September 2026, at which time Zenyaku will assume sole responsibility for sales of Rituxan® in Japan.

Rituximab was one of the first mAbs to become “biosimilar”.  Both Pfizer and Sandoz/Kyowa Kirin market rituximab biosimilars in Japan.  Bevacizumab biosimilars have also been marketed in Japan for some time, including by Celltrion (Vegzelma™, launched January 2023) and Daiichi Sankyo/Amgen (bevacizumab BS for intravenous drip infusions, launched December 2019).

Alteogen’s Biosimilar Aflibercept Approved in Saudi Arabia

On 19 June 2026, The Asia Business Daily reported that Alteogen Biologics’ MENA region partner, SPIMACO, has received product approval for ALT-L9 (aflibercept), biosimilar to Regeneron/Bayer’s Eylea® (2 mg) from the Saudi Food and Drug Authority (SFDA).

The SFDA is a major regulatory agency in the Middle East and many MENA countries refer to SFDA approval results during their own regulatory review processes.  Alteogen therefore expects that the Saudi Arabian approval will expedite approval of ALT-L9 in other key MENA countries, including the United Arab Emirates, where regulatory review is underway.

ALT-L9 is the first biosimilar developed by Alteogen.  Alteogen entered into an exclusive agreement with SPIMACO in 2024 for the commercialisation rights to ALT-L9 in 16 MENA countries.

ALT-L9 was approved in Europe as Eyluxvi® in September 2025, following a positive CHMP opinion in July 2025.  In May 2026, Alteogen announced that the Korean Ministry of Food and Drug Safety had approved ALT-L9 as Eyzanfy™, 20 months after Alteogen had submitted its Korean marketing authorisation application in September 2024.

There are currently other established partnerships in relation to the commercialisation of aflibercept biosimilars in the MENA region.  This includes Formycon and MS Pharma, which partnered in May 2024 in relation to the commercialisation of Formycon’s FYB203 (aflibercept) in MENA, and Bioventure and Amman Pharmaceutical Industries, which entered into a licence agreement in 2023 under which Amman Pharma was granted exclusive rights to register and commercialise the Alvotech-developed aflibercept biosimilar in the Levant region.

Samsung Bioepis and Organon Expand Canadian Collaboration to Include Biosimilar Ustekinumab

On 18 June 2026, Samsung Bioepis and Organon announced the expansion of their development and commercialisation agreement for Canada to include Samsung Bioepis’ Pyzchiva® (SB17), biosimilar to J&J’s Stelara® (ustekinumab).  Current plans are for Pyzchiva® to be launched in Canada during 2026.

Under the terms of the expanded agreement, Organon will obtain the exclusive Canadian commercialisation rights to Pyzchiva®, while Samsung Bioepis retains full development, manufacturing, and regulatory responsibilities.

The new agreement expands the biosimilar portfolio under Samsung Bioepis and Organon’s collaboration in Canada (first established in 2013) from five to six biosimilars.  In addition to Pyzchiva®, the biosimilars encompassed by the agreement are Hadlima® (adalimumab; launched 50mg/mL in March 2021; 100mg/mL approved August 2022), Brenzys® (etanercept; approved September 2016), Renflexis® (infliximab; launched March 2018), Aybintio® (bevacizumab; launched November 2022), and Ontruzant® (trastuzumab; launched November 2022).

Samsung Bioepis had previously entered into an exclusive agreement with Sandoz in September 2023 for the development and commercialisation of SB17 in the US, Canada, EEA, Switzerland and the UK.  Sandoz launched Pyzchiva® in Europe in July 2024 and in the US in February 2025.

Pyzchiva® was approved in Canada in August 2024.  Other ustekinumab biosimilars approved and launched in Canada to date, include JAMP/Alvotech’s Jamteki® (approved November 2023, launched March 2024), Amgen’s Wezlana® (approved December 2023, launched March 2024), Celltrion’s Steqeyma® (approved July 2024, launched August 2024), Fresenius’ Otulfi® (approved January 2025, launched May 2025), Biocon’s Yesintek™ (approved October 2025, launched mid-October 2025) and Dong-A ST/Intas’ Imuldosa™ (approved January 2026, not yet launched).

CSPC Pharmaceutical’s Biosimilar Secukinumab MAA Accepted in China

On 18 June 2026, CSPC Pharmaceutical Group announced that China’s National Medical Products Administration (NMPA) has accepted its marketing authorisation application (MAA) for Secukinumab Injection, biosimilar to Novartis’ Cosentyx®.

Cosentyx® is approved in China for the treatment of plaque psoriasis in patients aged 6 years and older; and for psoriatic arthritis, ankylosing spondylitis, hidradenitis suppurativa and non-radiographic axial spondyloarthritis in adults.  According to the announcement, In phase 1 and 3 studies, CSPC’s biosimilar demonstrated high similarity to Cosentyx® in terms of efficacy, safety, pharmacokinetics, and immunogenicity.

This news follows Celltrion’s announcement earlier in June 2026 that it has filed an application for its secukinumab biosimilar (CT-P55) in Canada, seeking all approved reference indications.  Celltrion is planning additional regulatory filings for CT-P55 in the US, Europe and Korea.

Other secukinumab biosimilars are under development, including Bio-Thera’s BAT2306 (phase 1 trial completed in 2023, phase 3 clinical trial in plaque psoriasis completed in 2024, commercialisation agreement with Dr Reddy’s in November 2025), Taizhou Mabtech Pharmaceutical’s CMAB015 (phase 1 trial completed in 2023) and Livzon Pharmaceutical Group’s LZM012 (phase 3 clinical trial in plaque psoriasis commenced).

Sanofi & Alteogen Confirm Development of Subcutaneous Dupilumab

On 18 June 2026, Korea Biomed reported that South Korean-headquartered Alteogen has disclosed in an investor communication that a non-exclusive licence agreement it announced in November 2019 for its ALT-B4 technology with an “undisclosed” pharmaceutical company was a deal with Sanofi regarding development of a high-dose subcutaneous formulation of Dupixent® (dupilumab).  ALT-B4 is a recombinant human hyaluronidase enzyme platform (berahyaluronidase alfa) designed to convert intravenous (IV) drugs into subcutaneous formulations.

The Sanofi deal was said by Alteogen in 2019 to potentially be worth up to USD 1.37 billion.  It has been disclosed that Sanofi paid USD13 million upfront in December 2019 and made two subsequent milestone payments, one in March 2020 for an undisclosed amount and a second of USD3 million in April 2023.  No details about the clinical stage of the development have been announced.

Alteogen has since partnered with a number of companies for the use of ALT-B4 in the subcutaneous formulations.  In November 2024, Alteogen signed an exclusive US$300 million licence agreement with Daiichi Sankyo for the development and commercialisation of a subcutaneous injection form of Enhertu® (trastuzumab deruxtecan).  In January 2026, Alteogen entered an exclusive licence agreement with Tesaro, a GSK subsidiary, for the use of ALT-B4 in the development and commercialisation of a subcutaneous formulation of dostarlimab.

Alteogen collaborates with MSD on subcutaneous Keytruda® (pembrolizumab).  MSD’s subcutaneous pembrolizumab was approved in the US, as Keytruda Qlex™, in September 2025 across 38 indications and has also been approved in Europe (November 2025), Canada (February 2026) and Korea (May 2026).

In January 2023, Alteogen entered into an exclusive agreement with Sandoz for the use of ALT-B4 to develop a subcutaneous version of an undisclosed Sandoz biosimilar product, with an option for Sandoz to licence the Alteogen technology for two further products.

Sandoz Opens USD 99M Biosimilar Development Centre in Slovenia

On 17 June 2026, Sandoz announced the opening of its new biosimilar development centre in Ljubljana, Slovenia.  The construction of the fully digitally integrated USD 99 million facility was first announced in July 2025.

The centre will support end-to-end drug development and is fully integrated into the development network, including bioanalytical and bioassay laboratories in Holzkirchen, Germany and device development in Cambridge, UK.  The Slovenia biosimilar development centre is the first of three major investment projects in Slovenia, with Sandoz planning to invest a total of USD 1.1 billion across the three projects.

The new development centre joins Sandoz’s new facilities for drug production in Lendava, sterile production and packaging in Brnik and a biosimilar site acquired in Toulouse, France.  It follows Sandoz’s creation of a new global biosimilar development, manufacturing and supply unit, which came into effect on 1 April 2026.

According to Sandoz’s CEO, Richard Saynor, the new biosimilar development centre in Slovenia, together with Sandoz’s other manufacturing investments, will “help move biosimilars efficiently into production, supporting our ‘golden decade’ of more affordable healthcare, with approximately USD 320 billion in biologic patent expiries expected over the next decade”.

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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