Biosimilars Deals 2021 Archives | Page 8 of 8

Pearce IP BioBlast® for the week ending 18 July 2025

Jul 22, 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 18 July 2025 are set out below:

Adalimumab

9 July 2025 | NL | Amsterdam Court Declares PAF’s Claim Against AbbVie Inadmissible

On 9 July 2025, the Amsterdam District Court ruled that the Pharmaceutical Accountability Foundation (PAF) lacked standing in its collective claim against AbbVie regarding the sale of Humira®… Read more here.

Aflibercept

18 July 2025 | KR | Korean Court Refuses Regeneron/Bayer’s Document Requests in Aflibercept Litigation Against Sam Chun Dang

In an article dated 18 July 2025, HiT News reported on a hearing in a patent infringement lawsuit filed by Regeneron and Bayer against Sam Chun Dang (SCD) and Optus Pharmaceutical in the Seoul… Read more here.

Aflibercept, Ranibizumab

17 July 2025 | US | Samsung Bioepis Transitions from Biogen to Harrow for US Commercialisation of Aflibercept/Ranibizumab Biosimilars

On 17 July 2025, Samsung Bioepis announced that it has entered into a licence, development and commercialisation agreement with eyecare pharmaceutical company, Harrow, in relation to Samsung Bioepis’ US ophthalmology… Read more here.

Golimumab

16 July 2025 | US | Bio-Thera/Accord’s Biosimilar Golimumab BLA Accepted for FDA Review

On 16 July 2025, Bio-Thera Solutions announced that the FDA has accepted for review its Biological Licence Application (BLA) for BAT2506, biosimilar to J&J’s Simponi® (golimumab). BAT2506 is being… Read more here.

Insulin aspart

15 July 2025 | US | Biocon’s Biosimilar Insulin Aspart US-Approved as First Interchangeable Biosimilar to Novo Nordisk’s NovoLog®

On 15 July 2025, Biocon Biologics announced that the FDA has approved Kirsty™ (insulin aspart-xjhz) as the first and only interchangeable biosimilar to Novo Nordisk’s NovoLog®… Read more here.

Nivolumab

18 July 2025 | IN | Court Grants Preliminary Injunction Preventing Indian Launch of Zydus’ Biosimilar Nivolumab

On 18 July 2025, the Delhi High Court issued a preliminary injunction restraining Zydus Lifesciences from launching its nivolumab biosimilar (ZRCr-4276) in India. The injunction was granted in… Read more here.

Pembrolizumab

21 July 2025 | Update on Pembrolizumab Biosimilar Clinical Trials

With a number of biosimilars to MSD’s Keytruda® (pembrolizumab) currently in clinical trials, we provide the following update on those trials and their status, based on previous reports and the… Read more here.

Tocilizumab

16 July 2025 | Celltrion Announces Results of Ph 3 Tocilizumab Switching Study

On 16 July 2025, Celltrion announced the results of its global phase 3 trial comparing the efficacy and safety of its tocilizumab biosimilar, Avtozma® (CT-P47), to reference drug, Roche’s Actemra®… Read more here.

Biosimilar Policy

14 July 2025 | EU | Samsung Bioepis Whitepaper Proposes EU Biosimilar Reforms

On 14 July 2025, Samsung Bioepis published a whitepaper entitled “Solving the Biosimilar Void in Europe”, which proposes various recommendations for European biosimilar policy reform… Read more here.

About Pearce IP

Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the life sciences industries (in particular, pharmaceutical, biopharmaceutical, biotech, ag-tech and food tech). Pearce IP is the 2021 ‘Intellectual Property Team of the Year’ (Lawyers Weekly Australian Law Awards) and was shortlisted for the same award in 2022. Pearce IP is ranked in IAM Patent 1000 and Managing IP (MIP) IP Stars, in Australasian Lawyer 5 Star Awards as a ‘5 Star’ firm, and the Legal 500 APAC Guide for Intellectual Property.

Our leaders have been recognised in virtually every notable IP listing for their legal, patent and trade mark excellence including: IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WIPR Leaders, 5 Star IP Lawyers, Best Lawyers, and Australasian Lawyer 5 Star Awards, and have been honoured with many awards including Australian Law Awards – IP Partner of the Year, Women in Law Awards – Partner of the Year, Women in Business Law Awards - Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.

Naomi Pearce

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

Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners. Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry. Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renown for her successful and elegant IP/legal strategies.

Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology client choice award recipient for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2021 Lawyers Weekly Women in Law SME “Partner of the Year”. Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.

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 and now at Pearce IP.

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.

Nathan Kan

Lawyer

Nathan is a lawyer focused on providing legal services and advice to life sciences clients, with a focus on litigation support regarding intellectual property (patents, trade marks, designs, copyright, domain names, plant breeders rights and confidential information) and commercial disputes.

Nathan is passionate about the intersection of law and science. Whilst serving as Sponsorship Director and subsequently as Vice President of the Science and Technology Law Association (SATLA) at the University of Melbourne, he led various engagement events, workshops and publications covering a range of STEM fields, including life sciences, artificial intelligence and digital transformation.

FDA Rejects Accelerated Approval of RP1 with Nivolumab for Melanoma

Jul 22, 2025

On 22 July 2025, Replimune announced that the FDA has advised it is unable to approve, in its present form, the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with BMS’ Opdivo® (nivolumab) for the treatment of advanced melanoma. The FDA considers that the clinical trial relied on is not an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness. The FDA also said the trial cannot be adequately interpreted due to the heterogeneity of the patient population. However, no safety issues were raised.

Replimune submitted the BLA in November 2024 under the FDA’s Accelerated Approval pathway. The company says that the FDA’s issues were not raised during the mid- and late-cycle reviews, and that they had aligned on the design of the study, but will continue engage with the FDA to find a path forward for approval.

Update on Pembrolizumab Biosimilar Clinical Trials

Jul 21, 2025

With a number of biosimilars to MSD’s Keytruda® (pembrolizumab) currently in clinical trials, we provide the following update on those trials and their status, based on previous reports and the information available to date in the clinicaltrials.gov registry:

Samsung Bioepis (SB27): Ph 3 study to compare efficacy, safety, PK and immunogenicity between SB27 and Keytruda® in patients metastatic nsNSCLC initiated in April 2024. The study is currently recruiting with estimated primary completion in September 2025.
Amgen (ABP 234): Ph 3 study in nsNSCLC initiated May 2024 to compare PK between ABP 234 and Keytruda® in patients with early-stage nsNSCLC as adjuvant treatment following resection and platinum-based chemotherapy. The study is currently recruiting, with estimated primary completion in March 2026. Ph 3 study commenced in September 2024 to compare the efficacy, PK, safety and immunogenicity between ABP 234 and Keytruda® in patients with advanced or metastatic nsNSCLC. The study is currently recruiting, with estimated primary completion in February 2028.
Formycon (FYB206): Integrated Ph1/3 study commenced in June 2024 to demonstrate PK similarity of FYB206 with Keytruda® in patients with Stage IIB/IIC or Stage III melanoma. On 10 July 2025, Formycon announced that it had completed patient enrolment. Formycon expects results to be available in Q1 2026. Formycon had originally intended to conduct a parallel Phase 3 trial to compare the safety and efficacy of FYB206 with Keytruda® in NSCLC. However, in February 2025, Formycon announced the premature termination of the Phase 3 trial on the basis that the trial was not necessary to obtain US approval of FYB206.
mAbxience (MB12): Ph 3 study to compare the PK, efficacy, safety and immunogenicity of MB12 versus Keytruda® in combination with pemetrexed-platinum chemotherapy as first-line treatment in patients with metastatic nsNSCLC. The study commenced in December 2024 and is currently recruiting, with estimated primary completion in June 2026.
Sandoz (GME751): Ph 1 study commenced in May 2024 to compare PK of GME751 and Keytruda® in patients with stage II and III melanoma requiring adjuvant treatment with pembrolizumab. The study is currently recruiting with estimated primary completion in July 2026. In April 2025, Sandoz announced it has “minimised” its Ph 3 trial in untreated metastatic nsNSCLC due to streamlining of FDA study requirements.
Celltrion (CT-P51): Ph 3 trial plan approved by FDA in August 2024 with study initiated in January 2025 to compare efficacy and safety of CT-P51 and Keytruda® in combination with platinum pemetrexed chemotherapy in patients with previously untreated metastatic nsNSCLC. The study is currently recruiting with estimated primary completion in February 2027.
Shanghai Henlius (HLX17): Integrated Ph 1/3 study initiated in April 2025 to evaluate the efficacy, safety, PK profile and immunogenicity of HLX17 vs Keytruda® in the first-line treatment of advanced nsNSCLC. The study is not yet recruiting, with estimated primary completion in April 2027.
Bio-Thera (BAT3306): Ph 1/3 study commenced in July 2024 to evaluate the PK, efficacy and safety of BAT3306 plus chemotherapy versus Keytruda® plus chemotherapy in patients with stage IV nsNSCLC. The study is currently recruiting with estimated primary completion in July 2027.
BioNTech (BNT327): Phase 2/3, Master Protocol for a Global Trial of BNT327 in combination with chemotherapy and other investigational agents in first-line NSCLC, initiated in January 2025. The study is currently recruiting, with estimated primary completion in December 2029.

Samsung Bioepis Publishes Tenth US Biosimilar Market Report; Considers US MFN Policy May Reduce Biosimilar Competition

Jul 21, 2025

On 21 July 2025, Samsung Bioepis published its US Biosimilar Market Report, which has been released every quarter since April 2023. The report details average sales price (ASP) and wholesale acquisition cost (WAC) information for commercially available biosimilars in the US.

The Q3/2025 edition reports that, as of June 2025, the FDA has approved 75 biosimilars, with 52 of those launched. On average, the ASP of biosimilars remained 20-30% lower than reference biologics, with increased discounts in crowded markets, such as those for adalimumab and ustekinumab.

The biosimilars US-approved in Q3 were Bio-Thera’s Starjemza® (ustekinumab, May 2025) and Biocon’s Jobevne^™ (bevacizumab, April 2025). Biosimilars with US launches in Q3 were Sandoz’s Jubbonti® and Wyost® (denosumab, June 2025) and Samsung Bioepis/Teva’s Epysqli® (eculizumab, April 2025).

According to the Report, biosimilars in the US have gained an average of 52% market share within 5 years post initial launch. However, some biosimilar markets have faster uptake speeds than others; in particular, oncology, ophthalmology and pegfilgrastim biosimilars reached an average of 81% market share 5 years post launch.

In a “Biosimilar Deep Dive”, the Samsung Bioepis Report considers potential implications of the US Government’s most favoured nation (MFN) policy on the US biosimilars market. The MFN policy aims to reduce drug costs by ensuring access to the lower prices typically paid by similar nations. The Report concludes that, although there remains uncertainty regarding MFN implementation, the policy may result in a smaller market, reducing commercial opportunities for biosimilars to enter and compete effectively and discouraging biosimilar manufacturers from investing in new products.

Court Grants Preliminary Injunction Preventing Indian Launch of Zydus’ Biosimilar Nivolumab

Jul 18, 2025

On 18 July 2025, the Delhi High Court issued a preliminary injunction restraining Zydus Lifesciences from launching its nivolumab biosimilar (ZRCr-4276) in India. The injunction was granted in proceedings brought by BMS alleging Zydus’ Indian launch of its nivolumab biosimilar will infringe Indian patent no. 340060 (IN ’060).

The Court found that IN ‘060, which expires on 2 May 2026, covers BMS’ Opdivo® (nivolumab), sold as Opdyta® in India. The Court also held that the patent’s validity was not sufficiently in doubt. IN ‘060 had survived four pre-grant oppositions, filed by Indian Pharmaceutical Alliance (IPA), Pankaj Kumar Singh, Restech Pharmaceuticals and Dr. Reddy’s. In addition, the validity of corresponding foreign patents had been upheld. While IN ‘060 was currently facing a post-grant opposition filed by Zydus, that opposition had not yet been finalised.

As well as preventing launch before the patent’s expiry, the preliminary injunction prohibits the post-expiry sale of ZRCr-4276 manufactured before that expiry date. Under Indian law, infringing goods manufactured during the term of a patent remain infringing after the patent expires. Zydus has therefore been ordered to file an affidavit disclosing the quantity of biosimilar nivolumab it has already manufactured.

Zydus received regulatory approval for its nivolumab biosimilar from India’s CDSCO in July 2024. At least Amgen, Sandoz and Xbrane/Intas also have nivolumab biosimilars under development.

Zydus is no stranger to patent infringement proceedings in India, having faced patent infringement litigation brought by Roche in relation to its pertuzumab biosimilar.

Korean Court Refuses Regeneron/Bayer’s Document Requests in Aflibercept Litigation Against Sam Chun Dang

Jul 18, 2025

In an article dated 18 July 2025, HiT News reported on a hearing in a patent infringement lawsuit filed by Regeneron and Bayer against Sam Chun Dang (SCD) and Optus Pharmaceutical in the Seoul Central District Court. The lawsuit was filed by Regeneron/Bayer in January 2024 alleging that SCD’s licence agreement with an unnamed overseas company to supply its Eylea® (aflibercept, 2mg) biosimilar (SCD411) constituted infringement of Regeneron’s Korean Patent No. 659477. Regeneron/Bayer are seeking damages based on the alleged infringement.

According to the article, at the hearing on 17 July 2025, the Court refused Regeneron/Bayer’s request for an order that SCD submit various documents and information, including the details of the licence agreement and other internal documents relating to that agreement. SCD had objected to producing the documents on the basis that they were confidential and all contracts it entered in relation to biosimilar aflibercept were to take effect after expiry of the Korean patent.

The Court has reportedly narrowed the issues in dispute in the lawsuit to whether SCD’s entry into licence agreements before the expiry of the Korean patent constitutes patent infringement. A further hearing has been scheduled for 11 September 2025.

In March 2024, it was reported that Sam Chun Dang had entered an exclusive distribution agreement with an unnamed distributor to supply its aflibercept biosimilar in the UK, Belgium, the Netherlands, Norway, Portugal, Sweden, Greece, Ireland and Finland. SCD’s biosimilar was also the subject of an exclusive distribution agreement reported in November 2023 with an unnamed distributor, for supply to Austria, Germany, Italy, Spain and Switzerland. SCD reportedly licensed SCD411 to Apotex for the Canadian market in August 2023.

DRUG ADVERTISING IN NEW ZEALAND – NZ allows advertising of unapproved drugs… soon

Jul 18, 2025

The New Zealand government has reiterated its plans to reform the law and allow the advertisement at medical conferences and trade shows of medicines not approved by the New Zealand medicines regulator, Medsafe. The stated intent behind this reform is to bring New Zealand into line with comparable countries and to make New Zealand more attractive as a potential host for such events.

However, suppliers of medicines ought to be aware that:

(1) The law prohibiting the advertising of unapproved medicines in New Zealand has not yet been changed.

(2) Advertising unapproved medicines in New Zealand, even to medical professionals at conferences and trade events, remains a criminal offence under section 20 of the Medicines Act 1981 and is subject to a fine of up to NZ$100,000 and, in the case of individuals, imprisonment for up to 6 months.

The planned reforms were first announced in late April 2025 and appear to have been prompted by representations from the industry body, Business Events Industry Aotearoa (BEIA). The Ministry of Regulation says that the government has “agreed to reform” this law, which would require amendment of the Medicines Act. No draft amendment legislation has yet been published. Although there is currently a Medicines Amendment Bill before Parliament, promoted by Regulation Minister David Seymour, this Bill does not include any proposed amendments relating to advertising of unapproved medicines. It is not clear whether the necessary advertising-related amendments are intended to be the subject of a separate future Bill, or added to the current Bill which remains under consideration by a parliamentary select committee.

Medsafe’s guidance on marketing unapproved medicines remains unchanged. That guidance is clear that unapproved medicines cannot lawfully be advertised in New Zealand. The Ministry of Health has not released any comment on the proposed reforms.

Pearce IP is following these proposed reforms with interest and will report on any further developments. (Subscribe here to receive any updates.)

The recent press release from Minister Seymour and Health Minister, Simeon Brown, suggests that the proposed reforms are connected to the decisions of the Australian and New Zealand College of Anaesthetists (ANZCA) and the Royal Australian and New Zealand College of Ophthalmologists (RANZCO) to hold major conferences in New Zealand in 2026. In fact, the decisions to hold these events in New Zealand appear to predate the policy, being announced in May 2025 and December 2024 respectively.

Minister Seymour is the leader of the ACT Party, one of two junior partners in New Zealand’s coalition government which is led by Minister Browne’s National Party. In the last election, ACT campaigned heavily on reducing regulation perceived as unfriendly to business. The Ministry of Regulation was established as part of the coalition deal between National and Act. This may explain Minister Seymour’s eagerness to publicize his party’s medicines advertising policy by reference to the ANZCA and RANZCO conferences.

For further information on medicine regulation in New Zealand, contact our New Zealand executives, Paul Johns, Julie Balance and Sally Paterson.

About Pearce IP

Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the life sciences industries (in particular, pharmaceutical, biopharmaceutical, biotech, ag-tech and food tech). Pearce IP is the 2021 ‘Intellectual Property Team of the Year’ (Lawyers Weekly Australian Law Awards) and was shortlisted for the same award in 2022. Pearce IP is ranked in IAM Patent 1000 and Managing IP (MIP) IP Stars, in Australasian Lawyer 5 Star Awards as a ‘5 Star’ firm, and the Legal 500 APAC Guide for Intellectual Property.

Our leaders have been recognised in virtually every notable IP listing for their legal, patent and trade mark excellence including: IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WIPR Leaders, 5 Star IP Lawyers, Best Lawyers, and Australasian Lawyer 5 Star Awards, and have been honoured with many awards including Australian Law Awards – IP Partner of the Year, Women in Law Awards – Partner of the Year, Women in Business Law Awards - Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.

Paul Johns

Executive, Lawyer (NZ, AU) & Trade Mark Attorney (NZ), (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 is recommended for litigation in the IAM Patent 1000, rated bronze for enforcement and litigation in the WTR1000, ranked Band 4 for Intellectual Property Asia-Pacific in Chambers, and recognised for Intellectual Property and Litigation in Best Lawyers.

Paul is a member of New Zealand’s Copyright Tribunal. He is the Vice Chair of the Patent Law Subcommittee of the IP and Entertainment Law Committee of the International Bar Association. Paul is also a member of the Intellectual Property Society of Australia and New Zealand and is an Associate Member of New Zealand Intellectual Property Attorneys Inc.

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.

Julie Ballance

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

Julie is a senior Trans-Tasman patent attorney, and a New Zealand registered lawyer and notary public with more than 30 years’ experience across a range of technology areas and a first class honours degree in chemistry. Julie is internationally renowned for her considerable patent/trade mark/designs/legal prowess, including being ranked in IAM Patent 1000.

LinkedIn

Samsung Bioepis Transitions from Biogen to Harrow for US Commercialisation of Aflibercept/Ranibizumab Biosimilars

Jul 17, 2025

On 17 July 2025, Samsung Bioepis announced that it has entered into a licence, development and commercialisation agreement with eyecare pharmaceutical company, Harrow, in relation to Samsung Bioepis’ US ophthalmology portfolio. The agreement follows Biogen’s October 2024 decision to terminate its November 2019 agreement with Samsung Bioepis, within the US and Canada, for commercialisation of Samsung Bioepis’ ophthalmology biosimilars.

Under the new agreement, Harrow will assume full commercial responsibility in the US for Samsung Bioepis’ Byooviz® (ranibizumab-nuna), biosimilar to Genentech’s Lucentis®, and Opuviz® (aflibercept-yszy), biosimilar to Regeneron’s Eylea®, upon full transition of Biogen’s commercialisation rights back to Samsung Bioepis by the end of 2025.

Opuviz® was the first FDA approved interchangeable aflibercept biosimilar (with Biocon’s Yesafili™) in May 2024. The US launch date for the product remains uncertain due to ongoing patent litigation brought by Regeneron against Samsung Bioepis (amongst others) regarding aflibercept. A preliminary injunction was granted, and remains in place, preventing Opuviz®’s US launch (14 June 2024, upheld on appeal on 29 January 2025).

Byooviz® was FDA approved in September 2021, launched in the US on 2 June 2022 and approved as interchangeable to Lucentis® across all approved indications in October 2023.

Celltrion Announces Results of Ph 3 Tocilizumab Switching Study

Jul 16, 2025

On 16 July 2025, Celltrion announced the results of its global phase 3 trial comparing the efficacy and safety of its tocilizumab biosimilar, Avtozma® (CT-P47), to reference drug, Roche’s Actemra®. The results demonstrated comparable efficacy, pharmacokinetics, safety and immunogenicity between patient groups that maintained the reference product and those that switched to Avtozma®.

Celltrion launched Avtozma® in Korea in June 2025, following its approval in December 2024 for the same indications as Actemra®. Just days earlier, Australia’s Therapeutic Good’s Administration (TGA) approved Avtozma® as the first tocilizumab biosimilar in the country.

In February 2025, Avtozma® became the third tocilizumab biosimilar approved in the EU, following Fresenius Kabi’s Tyenne®, in both IV and SC forms, in November 2023, and Biogen’s IV Tofidence™, in June 2024. Avtozma® was also the third tocilizumab biosimilar approved in the US in January 2025, trailing Fresenius Kabi’s Tyenne® (tocilizumab-aazg) (SC formulation, March 2024) and Biogen/Bio-Thera’s Tofidence®/BAT1806 (tocilizumab-bavi) (IV formulation, September 2023).

Bio-Thera/Accord’s Biosimilar Golimumab BLA Accepted for FDA Review

Jul 16, 2025

On 16 July 2025, Bio-Thera Solutions announced that the FDA has accepted for review its Biological Licence Application (BLA) for BAT2506, biosimilar to J&J’s Simponi® (golimumab). BAT2506 is being developed and manufactured by Bio-Thera and will be commercialised in the US by Intas Pharmaceuticals’ subsidiary, Accord Biopharma, under a February 2025 agreement.

The BAT2506 BLA is the second BLA for a golimumab biosimilar to be accepted by the FDA, following acceptance of Alvotech/Teva’s BLA for AVT05 in January 2025, approval of which is expected in Q4 2025.

Accord’s BLA for BAT2506 requests approval for all currently approved indications of Simponi®, including the following treatments for adults: moderately to severely active rheumatoid arthritis (RA) (with methotrexate), active psoriatic arthritis (alone or with methotrexate), active ankylosing spondylitis and moderately to severely active ulcerative colitis.

Bio-Thera has entered commercialisation agreements for BAT2506 in jurisdictions outside the US, including with SteinCares for Latin America (March 2024), STADA in Europe, the UK and selected other countries (May 2024), and Dr Reddy’s for South East Asia (March 2025).

In February 2025, Bio-Thera/STADA’s European marketing authorisation application (MAA) for BAT2506 was accepted by the European Medicines Agency (EMA). In November 2024, Alvotech/Advanz Pharma’s European marketing authorisation application for AVT05 was the first golimumab biosimilar MAA to be accepted anywhere in the world.

PiPCast™ | AU & NZ Trade Mark Examination Trends

Jul 16, 2025

Pearce IP’s Head of Trade Marks, Kimberley Evans, speaks to CEO, Naomi Pearce, about current trade mark examination trends in Australia and New Zealand and what objections you can reasonably expect when a trade mark application is examined in Australia or New Zealand.

Accord/Intas’ Biosimilar Denosumab Set for Oct 2025 US Launch Following Settlement with Amgen

Jul 16, 2025

On 16 July 2025, the US District Court for the District of New Jersey made consent orders reflecting a settlement of the patent infringement litigation brought by Amgen against Accord and Intas relating to Accord/Intas’ biosimilar denosumab. While the terms of the settlement agreement are confidential, the consent orders restrain Accord/Intas from launching biosimilar denosumab in the US until 1 October 2025.

Amgen commenced BPCIA proceedings against Accord/Intas in November 2024, alleging infringement of 34 of Amgen’s US patents relating to denosumab and methods of its manufacture. The litigation followed Accord/Intas’ submission of an abbreviated Biologics Licence Application (aBLA) for INTP23, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab).

The proceeding against Accord/Intas was one of a number of proceedings that Amgen commenced in the US in relation to denosumab biosimilars, three of which have now settled. A dispute with Sandoz, commenced in May 2023, was resolved in April 2024, with Sandoz launching its denosumab biosimilars, Jubbonti® and Wyost®, in June 2025. Fresenius Kabi launched Conexxence® and Bomyntra® in early July 2025, following a global settlement agreement with Amgen, resulting in the dismissal of US BPCIA litigation commenced by Amgen in October 2024. Amgen and Celltrion also settled their BPCIA litigation in January 2025, with Celltrion launching Stoboclo® and Osenvelt® in July 2025.

Amgen still has pending US denosumab litigation against Hikma/Gedeon Richter, Shanghai Henlius/Organon, and Biocon, which have all had denosumab biosimilar applications accepted for review by the FDA.

Pearce IP BioBlast® for the week ending 11 July 2025

Jul 15, 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 11 July 2025 are set out below:

Certolizumab Pegol

9 July 2025 | Lupin & Zentiva Partner on Peg Certolizumab Biosimilar

On 9 July 2025, Lupin Limited and Zentiva Group announced that they have entered into a global licence and supply agreement for the commercialisation of Lupin’s certolizumab pegol biosimilar… Read more here.

Denosumab

9 July 2025 | AU | Approval Alert: Samsung Bioepis’ Denosumab Biosimilars AU Approved

On 9 July 2025, Samsung Bioepis’ denosumab biosimilars, Ospomyv® and Xborso® (SB16), biosimilars to Amgen’s Prolia® and Xgeva® respectively, were approved by Australia’s Therapeutic Goods… Read more here.

8 July 2025 | US | Celltrion is Third to Launch US Denosumab Biosimilars

On 8 July 2025, Celltrion announced the US launch of Stoboclo® and Osenvelt® (CT-P41), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively. Celltrion is the third sponsor to launch… Read more here.

7 July 2025 | UK | Approval Alert: Biocon’s Denosumab Biosimilars UK Approved

On 7 July 2025, Biocon announced that it has received marketing authorisations from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for its denosumab products Evfraxy® and Vevzuo®… Read more here.

Nivolumab, Ipilimumab

11 July 2025 | KR | New Indication Alert: Opdivo®/Yervoy® Combo Approved in Korea for HCC

On 11 July 2025, Ono Pharma announced that Korea’s Ministry of Food and Drug Safety has approved an indication extension for Opdivo® (nivolumab) in combination with Yervoy® (ipilimumab)… Read more here.

Pembrolizumab

10 July 2025 | Formycon Completes Patient Enrolment for Biosimilar Pembrolizumab Ph 1 Study

On 10 July 2025, Formycon announced that it has completed patient enrolment for its clinical study, “Dahlia”, which is comparing the pharmacokinetics, safety and tolerability of FYB206… Read more here.

Biosimilar Deals

9 July 2025 | Alvotech Acquires Swiss Assembly & Packaging Company Ivers Lee Group

On 9 July 2025, Alvotech announced that it has acquired Switzerland-headquartered Ivers Lee Group to expand its capacity for assembly and packaging and support its growth plans. According to… Read more here.

About Pearce IP

Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the life sciences industries (in particular, pharmaceutical, biopharmaceutical, biotech, ag-tech and food tech). Pearce IP is the 2021 ‘Intellectual Property Team of the Year’ (Lawyers Weekly Australian Law Awards) and was shortlisted for the same award in 2022. Pearce IP is ranked in IAM Patent 1000 and Managing IP (MIP) IP Stars, in Australasian Lawyer 5 Star Awards as a ‘5 Star’ firm, and the Legal 500 APAC Guide for Intellectual Property.

Our leaders have been recognised in virtually every notable IP listing for their legal, patent and trade mark excellence including: IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WIPR Leaders, 5 Star IP Lawyers, Best Lawyers, and Australasian Lawyer 5 Star Awards, and have been honoured with many awards including Australian Law Awards – IP Partner of the Year, Women in Law Awards – Partner of the Year, Women in Business Law Awards - Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.

Naomi Pearce

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

Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners. Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry. Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renown for her successful and elegant IP/legal strategies.

Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology client choice award recipient for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2021 Lawyers Weekly Women in Law SME “Partner of the Year”. Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.

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 and now at Pearce IP.

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.

Nathan Kan

Lawyer

Nathan is a lawyer focused on providing legal services and advice to life sciences clients, with a focus on litigation support regarding intellectual property (patents, trade marks, designs, copyright, domain names, plant breeders rights and confidential information) and commercial disputes.

Nathan is passionate about the intersection of law and science. Whilst serving as Sponsorship Director and subsequently as Vice President of the Science and Technology Law Association (SATLA) at the University of Melbourne, he led various engagement events, workshops and publications covering a range of STEM fields, including life sciences, artificial intelligence and digital transformation.

Biocon’s Biosimilar Insulin Aspart US-Approved as First Interchangeable Biosimilar to Novo Nordisk’s NovoLog®

Jul 15, 2025

On 15 July 2025, Biocon Biologics announced that the FDA has approved Kirsty™ (insulin aspart-xjhz) as the first and only interchangeable biosimilar to Novo Nordisk’s NovoLog®.

Kirsty™ (100 units/mL) will be available as a single-patient-use prefilled pen for subcutaneous use and a multiple dose vial for subcutaneous and intravenous use. It is indicated to improve glycaemic control in adults and paediatric patients with diabetes mellitus. Kirsty™ has been available in Europe and Canada since 2022.

In February 2025, Sanofi-Aventis’ Merilog™/Merilog™ SoloStar were approved as the first US biosimilars to NovoLog®. However, those products have not been granted interchangeability status. There were also two long-acting insulin biosimilar products (insulin glargine) approved in 2021, Biocon/Mylan’s Semglee® and Eli Lilly’s Rezvoglar® (reference product: Sanofi’s Lantus®).

Samsung Bioepis Whitepaper Proposes EU Biosimilar Reforms

Jul 14, 2025

On 14 July 2025, Samsung Bioepis published a whitepaper entitled “Solving the Biosimilar Void in Europe”, which proposes various recommendations for European biosimilar policy reform.

The whitepaper states that the current biosimilar policy environment in Europe needs “improvements to better reflect the value recognition of biosimilars and ultimately support a more sustainable market”. In particular, it identifies challenges that biosimilars face, with “restrictive and misaligned tailored Health Technology Assessment (HTA) and pricing and reimbursement (P&R) processes”; “tendering and cost-containment policies that lead to continuous price erosion” throughout the lifecycle of biosimilars; and polices that hinder sufficient uptake of biosimilars.

Against this background, Samsung Bioepis’ policy recommendations include the following:

Tailoring and streamlining HTA for biosimilars (eg. taking into account additional benefits of biosimilars, HTA waivers, indication extrapolation and mechanisms for acceleration);
Avoiding arbitrary price controls for biosimilars at launch (eg. unjustified mandatory discounts) and allowing price discounts to be achieved by market dynamics;
Ensuring national, regional and local tenders support diversification of supply and fair competition through multi-winner tenders with contract volume shares; transparent and periodic tender opening and a broad set of value criteria considerations; and
Implementing incentives to healthcare professionals to encourage prescribing and dispensing of biosimilars, based on shared decision making between physicians and patients

The whitepaper considers that “the most important step” is for “policymakers to shift from perceiving biosimilars solely as cost saving tools” and to recognise their “vital role in strengthening market efficiency, patient access and system resilience”.

New Indication Alert: Opdivo®/Yervoy® Combo Approved in Korea for HCC

Jul 11, 2025

On 11 July 2025, Ono Pharma announced that Korea’s Ministry of Food and Drug Safety has approved an indication extension for Opdivo® (nivolumab) in combination with Yervoy® (ipilimumab) for first-line IV treatment of patients with unresectable or metastatic hepatocellular carcinoma.

The combination therapy has previously been approved for HCC in other jurisdictions including Japan (June 2025), the US (April 2025), and the EU (March 2025).

At least Amgen, Sandoz and Xbrane/Intas have nivolumab biosimilars under development. In April 2025, Sandoz and Shanghai Henlius Biotech announced a global collaboration agreement for a biosimilar to BMS’ Yervoy® (ipilimumab).

Formycon Completes Patient Enrolment for Biosimilar Pembrolizumab Ph 1 Study

Jul 10, 2025

On 10 July 2025, Formycon announced that it has completed patient enrolment for its clinical study, “Dahlia”, which is comparing the pharmacokinetics, safety and tolerability of FYB206 (pembrolizumab) with MSD’s Keytruda® in malignant melanoma. The study was commenced in June 2024 and has now enrolled a total of 96 participants.

Formycon had originally intended to conduct a parallel Phase 3 trial (“Lotus”) to compare the safety and efficacy of FYB206 with Keytruda® in non-small cell lung cancer (NSCLC). However, in February 2025, Formycon announced the premature termination of the Phase 3 trial following communications with the US FDA and concluding that the trial was not necessary to obtain US approval of FYB206.

Formycon expects results of the study to be available in Q1 2026, with the earliest market entry of FYB206 being in 2029 for the US and after 2030 for the EU.

There are a number of other pembrolizumab biosimilars in clinical trials, including Celltrion’s CT-P51 (Ph 3 trial plan approved by FDA in August 2024), Bio-Thera’s BAT3306 (Ph 1/3 in nsNSCLC commenced in July 2024), Amgen’s ABP 234 (Ph 3 in nsNSCLC initiated May 2024), Samsung Bioepis’ SB27 (Ph 3 in metastatic nsNSCLC commenced April 2024) and Sandoz’s GME751 (Ph 1 commenced in May 2024).

In September 2024, Shanghai Henlius Biotech received approval in China for a clinical trial of its pembrolizumab biosimilar, HLX17 and, in June 2025, Alvotech and Dr Reddy’s announced that they entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a pembrolizumab biosimilar.

Amsterdam Court Declares PAF’s Claim Against AbbVie Inadmissible

Jul 9, 2025

On 9 July 2025, the Amsterdam District Court ruled that the Pharmaceutical Accountability Foundation (PAF) lacked standing in its collective claim against AbbVie regarding the sale of Humira® (adalimumab) in the Netherlands, finding that PAF did not hold the requisite interest in the claim.

PAF commenced proceedings against AbbVie in February 2023, alleging that AbbVie acted unlawfully by overcharging for Humira®, leading to the displacement of publicly insured health services and violating fundamental human rights under Article 2 of the European Convention on Human Rights, and further breached relevant competition laws by abusing its market power.

In a statement released on 9 July 2025, PAF says that it had estimated that AbbVie “earned as much as €1 billion in excess profit in the Netherlands, costing the health system an equivalent of 13,950 years of healthy life”, and that it was “disappointed that the court did not address the merits of [the] case”. PAF is considering an appeal.

Alvotech Acquires Swiss Assembly & Packaging Company Ivers Lee Group

Jul 9, 2025

On 9 July 2025, Alvotech announced that it has acquired Switzerland-headquartered Ivers Lee Group to expand its capacity for assembly and packaging and support its growth plans. According to Alvotech, the acquisition of Ivers Lee will provide “added flexibility and capacity to meet increased global demand” for Alvotech’s biosimilars, including the planned launch of three biosimilars in 2025.

This follows the June 2025 completion of Alvotech’s acquisition of Xbrane’s Swedish R&D operations and biosimilar to UCB’s Cimzia® (certolizumab pegol) in a US$28.9m deal.

Alvotech has also recently entered into a number of commercialisation agreements, including with Advanz Pharma in Europe in relation to AVT10, biosimilar to UCB’s Cimzia® (certolizumab pegol) (in July 2025) and canakinumab and ofatumumab biosimilars (in May 2025); and with Dr Reddy’s for the global development, manufacturing and commercialisation of a biosimilar to MSD’s Keytruda® (pembrolizumab) (in June 2025).

Alvotech’s AVT06, biosimilar to Bayer/Regeneron’s Eylea® (aflibercept, 2mg), received a positive CHMP opinion in June 2025 (it is to be commercialised in the EU by Advanz) and is expected to obtain US approval in Q4 2025 (Alvotech/Teva’s BLA having been accepted by the FDA in February 2025). Alvotech/Teva’s Selarsdi® was the second biosimilar to J&J/Janssen’s Stelara® (ustekinumab) launched in the US in February 2025.

Approval Alert: Samsung Bioepis’ Denosumab Biosimilars AU Approved

Jul 9, 2025

On 9 July 2025, Samsung Bioepis’ denosumab biosimilars, Ospomyv® and Xborso® (SB16), biosimilars to Amgen’s Prolia® and Xgeva® respectively, were approved by Australia’s Therapeutic Goods Administration (TGA), for all reference indications.

Samsung Bioepis is the third sponsor to obtain approval of denosumab biosimilars in Australia, following Sandoz’s Jubbonti® and Wyost® in August 2024 and Celltrion’s Stoboclo® and Osenvelt® in April 2025.

In December 2024, Sandoz’s denosumab biosimilars were recommended for listing on Australia’s Pharmaceutical Benefits Scheme (PBS). In November 2024, Amgen secured approvals for 5 new denosumab brands, suggesting that Amgen intends to cannibalise its own denosumab market in Australia. In May 2024, Amgen licensed generics giant Arrotex to supply Prolia® in Australia.

Samsung Bioepis’ denosumab biosimilars were approved in Europe and the US in February 2025 (as Obodence™ and Xbryk™). In August 2024, Amgen commenced US BPCIA patent infringement proceedings against Samsung Bioepis in relation to its denosumab biosimilars. Those proceedings are ongoing.

Lupin & Zentiva Partner on Peg Certolizumab Biosimilar

Jul 9, 2025

On 9 July 2025, Lupin Limited and Zentiva Group announced that they have entered into a global licence and supply agreement for the commercialisation of Lupin’s certolizumab pegol biosimilar referencing UCB’s Cimzia®.

Under the agreement, Lupin is responsible for development, manufacturing and supply, with split responsibility for commercialisation: Lupin will commercialise in the US and Canada, with Zentiva in ROW, predominantly Europe and CIS markets. Lupin will receive an initial payment of USD 10m and up to a further USD 50m on achievement of regulatory milestones, with profits from the defined markets to be shared by the companies.

Alvotech also has a certolizumab pegol biosimilar in development, AVT10, which it acquired from Xbrane in June 2025. In early July 2025, Alvotech and Advanz Pharma entered a European supply and commercialisation agreement for AVT10.

Pearce IP BioBlast® for the week ending 4 July 2025

Jul 8, 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 4 July 2025 are set out below:

Aflibercept

2 July 2025 | CA | Approval Alert: Apotex and Sam Chun Dang Announce Canadian Approval of Biosimilar Aflibercept

On 2 July 2025, Apotex announced that Aflivu™, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2mg), has been approved by Health Canada in pre-filled syringe and vial formats. Aflivu™ is… Read more here.

Certolizumab Pegol

1 July 2025 | EU | Alvotech and Advanz Enter EU Partnership for Certolizumab Pegol Biosimilar

On 1 July 2025, Alvotech and Advanz Pharma announced that the companies have entered into a European supply and commercialisation agreement for AVT10, Alvotech’s biosimilar to UCB’s… Read more here.

Daratumumab

4 July 2025 | KR | Korea Approves Phase 3 Trial for Celltrion’s Biosimilar Daratumumab

On 4 July 2025, The Bio reported that Korea’s Ministry of Food and Drug Safety has approved Celltrion’s Phase 3 clinical trial plan (IND) for CT-P44, biosimilar to Johnson & Johnson’s Darzalex®… Read more here.

Denosumab

3 July 2025 | EU | Approval Alert: European Commission Approves Denosumab Biosimilars of Richter, mAbxience and Biocon

Over the last week, the European Commission (EC) has approved denosumab biosimilars for three sponsors… Read more here.

1 July 2025 | KR | Samsung Bioepis Launches Denosumab Biosimilar in Korea and Strikes Licensing Deal with Boryung

On 1 July 2025, Samsung Bioepis and Hanmi Pharmaceutical announced that they have jointly launched Obodence™, biosimilar to Amgen’s Prolia® (denosumab), in South Korea, at a 13% cost… Read more here.

1 July 2025 | US | Fresenius Kabi Second to Launch US Biosimilar Denosumab

On 1 July 2025, Fresenius Kabi announced the US launch of Conexxence® and Bomyntra®, biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively. Fresenius’ denosumab biosimilars are… Read more here.

30 June 2025 | US | Amgen Expands US BPCIA Denosumab Litigation to include Biocon

On 30 June 2025, Amgen filed BPCIA litigation against Biocon in the in the US District Court for the District of Massachusetts, Eastern Division, asserting infringement of 34 US patents covering… Read more here.

Pertuzumab

28 June 2025 | CN | Study Demonstrates Biosimilarity of Beijing SL’s KM118 (Pertuzumab) with Roche’s Perjeta®

The results of a phase I study published in Annals of Medicine is said to have established biosimilarity between Beijing SL Pharmaceuticals’ pertuzumab biosimilar, KM118, and the reference product… Read more here.

Ranibizumab

1 July 2025 | AFRICA | Bioeq AG and Bio Usawa Partner to Commercialise Ranibizumab Biosimilar in Africa

On July 1 2025, Formycon announced that Bioeq AG, which holds the exclusive worldwide commercialisation rights for Formycon’s biosimilar to Genentech’s Lucentis® (ranibizumab)… Read more here.

Ustekinumab

1 July 2025 | JP | Celltrion to Launch Biosimilar Ustekinumab in Japan

On 1 July 2025, Pharma Japan reported that Celltrion will lauch Stegeyma® (CT-P43), biosimilar to J&J/Janssen’s Stelara® (ustekinumab), in Japan on 8 July 2025… Read more here.

Biosimilar Manufacturing

1 July 2025 | Sandoz to Expand EU Biosimilar Production with Slovenian Manufacturing Facility

On 1 July 2025, Sandoz announced that it has commenced construction of a new biosimilar production centre in Brnik, Slovenia, due to open in 2028. Sandoz is investing USD 440 million in the… Read more here.

Biosimilar Tendering

2 July 2025 | ES | Spain Issues €411M Tender for Biosimilar Medicines Supply

On 2 July 2025, Navlin Daily reported that the Spanish Ministry of Health issued a tender for the sustainable supply of biologics and biosimilars under a two-year Framework Agreement worth … Read more here.

About Pearce IP

Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the life sciences industries (in particular, pharmaceutical, biopharmaceutical, biotech, ag-tech and food tech). Pearce IP is the 2021 ‘Intellectual Property Team of the Year’ (Lawyers Weekly Australian Law Awards) and was shortlisted for the same award in 2022. Pearce IP is ranked in IAM Patent 1000 and Managing IP (MIP) IP Stars, in Australasian Lawyer 5 Star Awards as a ‘5 Star’ firm, and the Legal 500 APAC Guide for Intellectual Property.

Our leaders have been recognised in virtually every notable IP listing for their legal, patent and trade mark excellence including: IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WIPR Leaders, 5 Star IP Lawyers, Best Lawyers, and Australasian Lawyer 5 Star Awards, and have been honoured with many awards including Australian Law Awards – IP Partner of the Year, Women in Law Awards – Partner of the Year, Women in Business Law Awards - Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.

Naomi Pearce

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

Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners. Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry. Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renown for her successful and elegant IP/legal strategies.

Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology client choice award recipient for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2021 Lawyers Weekly Women in Law SME “Partner of the Year”. Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.

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 and now at Pearce IP.

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.

Nathan Kan

Lawyer

Nathan is a lawyer focused on providing legal services and advice to life sciences clients, with a focus on litigation support regarding intellectual property (patents, trade marks, designs, copyright, domain names, plant breeders rights and confidential information) and commercial disputes.

Nathan is passionate about the intersection of law and science. Whilst serving as Sponsorship Director and subsequently as Vice President of the Science and Technology Law Association (SATLA) at the University of Melbourne, he led various engagement events, workshops and publications covering a range of STEM fields, including life sciences, artificial intelligence and digital transformation.

Celltrion is Third to Launch US Denosumab Biosimilars

Jul 8, 2025

On 8 July 2025, Celltrion announced the US launch of Stoboclo® and Osenvelt® (CT-P41), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively. Celltrion is the third sponsor to launch denosumab biosimilars in the US, following Sandoz’s launch of Jubbonti® and Wyost® in June 2025 and the announcement of Fresenius Kabi’s launch of Conexxence® and Bomyntra® on 1 July 2025.

Celltrion secured FDA approval for its denosumab biosimilars in March 2025, following submission of its abbreviated Biologics Licence Application in December 2023. In May 2024, Celltrion was sued by Amgen in the District Court of New Jersey for alleged infringement of 29 patents regarding denosumab. That litigation was settled in January 2025, allowing Celltrion to launch its denosumab biosimilars in the US from 1 June 2025.

Samsung Bioepis is the only other sponsor with denosumab biosimilars approved in the US (Ospomyv™ and Xbryk™, approved February 2025), but it has not yet launched the products. BPCIA litigation commenced by Amgen against Samsung Bioepis regarding its denosumab biosimilars remains pending.

Amgen also has pending US BPCIA litigation against Accord/Intas, Hikma/Gedeon Richter and Shanghai Henlius/Organon, and Biocon, which have all had denosumab biosimilar applications accepted for review by the FDA.

Approval Alert: Biocon’s Denosumab Biosimilars UK Approved

Jul 7, 2025

On 7 July 2025, Biocon announced that it has received marketing authorisations from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for its denosumab products Evfraxy® and Vevzuo®, biosimilars to Amgen’s Prolia® and Xgeva® respectively, across all indications of the reference products.

Biocon is the fifth sponsor to have received marketing authorisation for its denosumab biosimilars in the UK, following Sandoz’s Wyost® and Jubbonti® (November 2024), Samsung Bioepis’ Obodence™ and Xbryk™ (March 2025), Celltrion’s Stoboclo® and Osenvelt® (May 2025) and Accord’s Osvyrti® (June 2025).

The UK approval of Evfraxy® and Vevzuo® comes a week after Biocon received EU approval for them.

Biosimilars Deals 2021

Adalimumab

Aflibercept

Aflibercept, Ranibizumab

Golimumab

Insulin aspart

Nivolumab

Pembrolizumab

Tocilizumab

Biosimilar Policy

About Pearce IP

Naomi Pearce

Chantal Savage

Nathan Kan

About Pearce IP

Paul Johns

Sally Paterson

Julie Ballance

Certolizumab Pegol

Denosumab

Nivolumab, Ipilimumab

Pembrolizumab

Biosimilar Deals

About Pearce IP

Naomi Pearce

Chantal Savage

Nathan Kan

Aflibercept

Certolizumab Pegol

Daratumumab

Denosumab

Pertuzumab

Ranibizumab

Ustekinumab

Biosimilar Manufacturing

Biosimilar Tendering

About Pearce IP

Naomi Pearce

Chantal Savage

Nathan Kan

Product specific reports based on extracts from our BioBlast® database

Biosimilars Deals

BioBlast® Editor and Contributing Author

Naomi Pearce & Emily Bristow

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