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Biosimilars Deals 2021

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

Pearce IP BioBlast® for the week ending 5 December 2025

Dec 9, 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 5 December 2025 are set out below:

Aflibercept

5 December 2025 | KR | Samsung Bioepis’ Biosimilar Aflibercept Set for Korean Market after Appeal Win
On 5 December 2025, Korea’s HIT News reported that Samsung Bioepis has successfully overturned a preliminary injunction granted to Regeneron and Bayer which was… Read more here.

26 November 2025 | CN | Boan Biotech’s Biosimilar Aflibercept Approved in China
On 26 November 2025, Boan Biotech announced that Boyoujing® (BA9101), biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), was approved by China’s National… Read more here.

Denosumab

2 December 2025 | EU | EU Denosumab Biosimilar Competition Heats Up with Launches from Fresenius, Samsung Bioepis, Accord & Zentiva

On 1 and 2 December 2025, European launches of denosumab biosimilars were announced by the following sponsors: Fresenius Kabi announced the 1 December… Read more here.

2 December 2025 | EU | Biocon Secures EU/ROW Deal for Biosimilar Denosumab Following Amgen Settlement, Launch in EU in December 2025
On 2 December 2025, Biocon announced that it has reached a settlement and licence with Amgen for Europe and ROW, permitting Biocon to launch its Evfraxy® and… Read more here.

24 November 2025 | US | Hikma/Richter & Amgen Settle BPCIA Denosumab Litigation
On 24 November 2025, consent orders were made by the US District Court for the District of New Jersey recording that Hikma Pharmaceuticals and Gedeon Richter have… Read more here.

Infliximab

2 December 2025 | CL | Celltrion’s Remsima SC First to LATAM Market
On 2 December 2025, Celltrion announced that it has launched Remsima® SC (infliximab) in Chile, marking the biosimilar’s first entrance into the public market in Central and South… Read more here.

Omalizumab

3 December 2025 | US | FDA Approves Celltrion’s 300mg Biosimilar Omalizumab

On 3 December 2025, Celltrion announced that it received FDA approval for a new 300 mg/2 mL pre-filled syringe presentation of Omlyclo®, biosimilar to Novartis’ Xolair®… Read more here.

Pembrolizumab

4 December 2025 | DE | Halozyme Obtains Preliminary Injunction Preventing Sales of MSD’s Keytruda SC™ in Germany
On 4 December 2025, Halozyme announced that the Munich Regional Court has granted its application for a preliminary injunction to prevent MSD from distributing and… Read more here.

4 December 2025 | MENA | Formycon and MS Pharma Ink Exclusive Deal for Biosimilar Pembrolizumab in MENA Region
On 4 December 2025, Formycon and MS Pharma announced that they have entered into an exclusive licensing and supply agreement for the commercialisation of FYB206… Read more here.

Pegfilgrastim

4 December 2025 | US | Lupin’s Pegfilgrastim FDA Approved & to be Commercialised in US by Valorum
On 1 December 2025, Lupin announced that the US FDA has approved Armlupeg™, biosimilar to Amgen’s Neulasta® (pegfilgrastim) in 6 mg/0.6 mL pre-filled syringe (PFS) form.. Read more here.

Ranibizumab

2 December 2025 | EU | Positive CHMP Opinion for Samsung Bioepis’ PFS Presentation of Biosimilar Ranibizumab
On 2 December 2025, Samsung Bioepis announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion… Read more here.

Tocilizumab

4 December 2025 | NZ | Celltrion’s Avtozma® is First Biosimilar Tocilizumab Approved in New Zealand
On 4 December 2025, New Zealand’s Medsafe approved Celltrion’s Avtozma®, biosimilar to Roche’s Actemra® (tocilizumab), in vial (intravenous) and pre-filled syringe (subcutaneous)… Read more here.

Trastuzumab

8 December 2025 | Celltrion to Expand Use of SC Formulation Technology Including to Develop SC Trastuzumab Biosimilar
On 8 December 2025, Celltrion announced that it intends to expand its biosimilar pipeline by “internalising” hyaluronidase-based subcutaneous delivery (SC) formulation technology… Read more here.

Ustekinumab

1 December 2025 | US | Express Scripts adds Accord Biosimilar Ustekinumab to Formularies
On 1 December 2025, Accord BioPharma announced that Express Scripts has added Imuldosa®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), to its largest commercial… Read more here.

BioPharma Deals

6 December 2025 | Biocon Limited to Wholly Acquire Biocon Biologics, Valued at USD 5.5B
On 6 December 2025, Biocon Limited announced that Biocon Biologics will be integrated into it, becoming a wholly owned subsidiary of the company upon completion of the transaction… Read more here.

About Pearce IP

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

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 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.

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

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 renowned 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 Lexology Client Choice Award recipient in 2022 and 2026, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2024 Lawyers Weekly Women in Law “Executive 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.

Formycon & Zydus Ink Exclusive Deal for Biosimilar Pembrolizumab in US & Canada

Dec 9, 2025

On 9 December 2025, Formycon and Zydus Lifesciences announced that they have entered into an exclusive licensing and supply agreement for the commercialisation of FYB206, biosimilar to MSD’s Keytruda® (pembrolizumab), in the US and Canada.

Under the agreement, Formycon will have responsibility for preparing and filing the regulatory dossier and supplying FYB206, while Zydus will commercialise the product in the US and Canada. The deal will provide Formycon with an upfront payment in the mid-teens of millions of euros and eligibility for milestone payments in 2025, plus further payments linked to development and regulatory milestones, expected to be in the mid to double-digit millions of euros range. Formycon will also share in the gross profits generated by sales of the product.

The deal marks Zydus’ entry into the US biosimilar market. It follows quickly behind Formycon’s agreement with MS Pharma for the commercialisation of FYB206 in the MENA region, announced on 4 December 2025.

Formycon commenced an integrated Ph1/3 study 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.

Bioéticos claimed to have launched the first pembrolizumab biosimilar in Paraguay in August 2025 under the name Pembrolizumab Bioéticos. In November 2025, Biocad’s Pembroria™ (pembrolizumab) was reportedly approved in Vietnam. A number of other pembrolizumab biosimilars are currently in clinical trials, including by Samsung Bioepis, Amgen, mAbxience, Sandoz, Celltrion, Bio-Thera and BioNTech. Alvotech and Dr Reddy’s have entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a biosimilar to Keytruda®.

Celltrion to Expand Use of SC Formulation Technology Including to Develop SC Trastuzumab Biosimilar

Dec 8, 2025

On 8 December 2025, Celltrion announced that it intends to expand its biosimilar pipeline by “internalising” hyaluronidase-based subcutaneous delivery (SC) formulation technology. According to Celltrion, its SC technology involves temporarily decomposing hyaluronic acid present in subcutaneous tissues to facilitate drug diffusion.

Celltrion’s announcement states that it has been conducting clinical trials for Herzuma® SC (CT-P6 SC), biosimilar to Roche’s Herceptin® SC (trastuzumab hyaluronidase, marketed in the US as Herceptin Hylecta™) since February 2025 and plans to submit applications for approvals of the Herzuma® SC formulation to domestic and foreign regulatory agencies in the first half of 2026.

Herzuma® was launched in Europe in 2018 and in the US in March 2020.

Celltrion developed the world’s first subcutaneous injection of infliximab, Remsima SC®/Zymfentra®, which was launched in Europe in 2020 and in the US in 2024.

Binnopharm & Mabwell Partner on Biosimilar Dupilumab in Russia

Dec 8, 2025

On 8 December 2025, GxP News reported that Russia’s Binnopharm Group and China’s Mabwell have signed a MOU in relation to localising the production of Mabwell’s biosimilar to Regeneron/Sanofi’s Dupixent® (dupilumab) in Russia and the EAEU.

The two companies have previously partnered in 2022, with Binnopharm Group obtaining the exclusive rights for the production, registration and sale of Mabwell’s adalimumab and denosumab biosimilars (9MW0113, 9MW0321 and 9MW0311) in Russia and the EAEU. In January 2024, Mabwell’s adalimumab and denosumab biosimilars were approved for Phase III clinical trials in Russia, where Russian clinical data is required for local marketing, with Binnopharm to conduct and fund the trials.

There are a number of dupilumab biosimilars under development. A November 2025 report from Korean news outlet, The Asia News Daily, suggests that Samsung Bioepis is developing a dupilumab biosimilar. In August 2025, CSPC Pharmaceutical announced that it received approval from China’s National Medical Products Administration (NMPA) to conduct clinical trials of its dupilumab injection. In June 2025, Bio-Thera Solutions and Costa Rican-based SteinCares announced an agreement to commercialise biosimilar dupilumab across Latin America, with Bio-Thera responsible for product development and supply, and SteinCares responsible for commercialisation.

Alvotech and Advanz entered into partnership agreements in February 2023, May 2023 and June 2024 for the commercialisation of various biosimilars, including dupilumab, in Europe and certain other countries, with Alvotech responsible for development, and Advanz responsible for commercialisation.

Biocon Limited to Wholly Acquire Biocon Biologics, Valued at USD 5.5B

Dec 6, 2025

On 6 December 2025, Biocon Limited announced that Biocon Biologics will be integrated into it, becoming a wholly owned subsidiary of the company upon completion of the transaction, expected to occur by 31 March 2026.

Under the proposed transaction, Biocon Limited will acquire the minority stakes in Biocon Biologics currently held by Serum Institute Life Sciences, Tata Capital Growth Fund II and Activ Pine LLP, through a share swap of 70.28 Biocon shares for every 100 Biocon Biologics shares, reportedly valuing Biocon Biologics at USD 5.5 billion. Biocon will also acquire the residual stake held by Mylan Inc (Viatris) for USD 815 million, with a capital raising of USD 500 million through Qualified Institutional Placement approved by Biocon Limited’s Board (subject to shareholder approval) to help fund that acquisition.

According to Biocon, the integration will strengthen Biocon’s global position “to lead in key therapeutic areas” of diabetes, oncology and immunology. In particular, Biocon considers that it is “uniquely poised to address the rapidly expanding ‘diabesity’ market” as the “only company operating globally with both biosimilar insulins and generic versions of complex peptides, including GLP-1s”. Biocon’s Semglee® was the first biosimilar approved in the Unites States as interchangeable to Sanofi’s Lantus® (insulin glargine) (July 2021).

Samsung Bioepis’ Biosimilar Aflibercept Set for Korean Market after Appeal Win

Dec 5, 2025

On 5 December 2025, Korea’s HIT News reported that Samsung Bioepis has successfully overturned a preliminary injunction granted to Regeneron and Bayer which was preventing Korean sales of Samsung Bioepis’ Afilivu® (SB15), biosimilar to Regeneron/Bayer’s Eylea® (aflibercept).

The ruling of the Seoul High Court’s Civil Division, finding in favour of Samsung Bioepis, follows an October 2025 decision of the Korean Patent Court invalidating a Regeneron patent for ophthalmic formulations of aflibercept (the Korean equivalent to US Patent No. 11,084,865).

Afilivu® was the first aflibercept biosimilar approved in Korea in February 2024. In April 2024, it was reported that Samil Pharmaceutical would launch Samsung Bioepis’ aflibercept biosimilar in the Korean market from 1 May 2024. However, that launch was disrupted by the preliminary injunction. Following the appeal decision, Samsung Bioepis/Samil can now resume distribution of Afilivu® in Korea.

On 29 January 2025, the US Court of Appeals for the Federal Circuit refused to overturn a preliminary injunction preventing Samsung Bioepis from launching its aflibercept biosimilar in the US without a licence from Regeneron. This ruling affirmed an earlier decision of the US District Court for the Northern District of West Virginia in June 2024, finding that Samsung Bioepis infringed, and had failed to raise a substantial question of invalidity of, Regeneron’s US Patent No. 11,084,865 regarding ophthalmic formulations of aflibercept.

Breaking News – Formulation Patents No Longer Extensible in Australia as Pharmaceutical Patentees Prepare for PTE Shake Down

Dec 4, 2025

This morning the Full Court published its decision in Otsuka Pharmaceutical Co Ltd v Sun Pharma ANZ Pty Ltd [2025] FCAFC 161 confirming that pharmaceutical formulation patents are no longer eligible for a patent term extension in Australia.

Read more about the Australian patent extension regime in our free PTE eBook which can be downloaded Pharmaceutical Patent Term Extensions in Australia

In the fight between Otsuka and Sun Pharma over Sun Pharma’s launch of a generic version of ABILIFY MAINTENA (aripiprazole), the Full Court of the Federal Court of Australia held that only patents for active pharmaceutical substances – not pharmaceutical formulations- are eligible for a patent term extension. The decision was handed down on 1 December, but published today.

The Full Court decision has huge ramifications for stakeholders in the Australian pharmaceutical sector. Originator companies will no longer be able to extend the term of pharmaceutical formulation patents, and their existing patent term extensions for pharmaceutical formulation patents will now be vulnerable to challenge. Given this seismic shift in the law, we expect Otsuka to seek special leave to appeal to the High Court of Australia.

In the meantime:

Patentees will be urgently reviewing their patent portfolios and revisiting their loss of exclusivity dates in Australia as they prepare for the inevitable rectification applications from generic/biosimilar applicants; and
Biosimilar and generic applicants will be inducing their market entry dates, and preparing to file low-cost rectification applications in the patent office, where the originator’s exclusivity was (previously) underpinned by a formulation patent.

Our detailed blog on the Otsuka decision and its implications will follow.

Read more about the Australian patent extension regime in our free PTE eBook which can be downloaded Pharmaceutical Patent Term Extensions in Australia

About Pearce IP

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

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

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

Helen Macpherson

Executive, Lawyer (Head of Litigation –Australia)

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

Formycon and MS Pharma Ink Exclusive Deal for Biosimilar Pembrolizumab in MENA Region

Dec 4, 2025

On 4 December 2025, Formycon and MS Pharma announced that they have entered into an exclusive licensing and supply agreement for the commercialisation of FYB206, biosimilar to MSD’s Keytruda® (pembrolizumab) in the MENA region.

Under the agreement, Formycon will receive an upfront payment and will be eligible for further payments subject to certain development and regulatory milestones. Formycon will also receive a share of the gross profits generated by sales of the biosimilar in the MENA region. The agreement further includes an option for future technology transfer.

According to Formycon, the licensing deal with MS Pharma represents the “start of the commercial partnering activities” for FYB206, with further agreements for additional regions and countries to follow.

Formycon and MS Pharma have previously partnered on the commercialisation of biosimilars in the MENA region, including FYB202/Otulfi® (ustekinumab), FYB203 (aflibercept) and FYB201/Ravegza® (ranibizumab).

Celltrion’s Avtozma® is First Biosimilar Tocilizumab Approved in New Zealand

Dec 4, 2025

On 4 December 2025, New Zealand’s Medsafe approved Celltrion’s Avtozma®, biosimilar to Roche’s Actemra® (tocilizumab), in vial (intravenous) and pre-filled syringe (subcutaneous) presentations, making Avtozma® the first tocilizumab biosimilar approved in New Zealand.

Avtozma® has previously been granted marketing authorisation in a number of other regions, including as the first tocilizumab biosimilar approved in Australia (May 2025) and Japan (September 2022), and will be considered for listing on Australia’s PBS at PBAC’s November 2025 meeting.

Avtozma® was the third tocilizumab biosimilar approved in the US (January 2025), and was subsequently launched in an IV formulation in October 2025. Biogen/Bio-Thera’s Tofidence®/BAT1806 was the first US approved tocilizumab biosimilar (IV formulation, September 2023; launched May 2024), followed by Fresenius Kabi’s Tyenne® (SC formulation, March 2024; IV formulation launched April 2024; SC formulation launched July 2024).

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.

Lupin’s Pegfilgrastim FDA Approved & to be Commercialised in US by Valorum

Dec 4, 2025

On 1 December 2025, Lupin announced that the US FDA has approved Armlupeg™, biosimilar to Amgen’s Neulasta® (pegfilgrastim) in 6 mg/0.6 mL pre-filled syringe (PFS) form. Just days later, on 4 December 2025, Lupin also announced that it entered into an exclusive licensing agreement with Valorum Biologics for the US commercialisation of Armlupeg™.

Under the terms of the licence agreement, Valorum will be the responsible for commercialisation and distribution of Armlupeg™, while Lupin will be responsible for manufacturing and supply of the product and will receive an upfront licence fee and a royalty payment on net sales.

There are a number of other pegfilgrastim biosimilars approved in the US, including Biocon’s Fulphila® (June 2018), Coherus/Accord’s Udenyca® (November 2018), Sandoz’s Ziextenzo® (November 2019), Pfizer’s Nyvepria® (June 2020), Amneal/Kashiv’s Fylnetra™ (May 2022), and Fresenius’ Stimufend® (September 2022).

The US approval of Armlupeg™ follows approval by Health Canada in August 2024 for the same presentation.

Halozyme Obtains Preliminary Injunction Preventing Sales of MSD’s Keytruda SC™ in Germany

Dec 4, 2025

On 4 December 2025, Halozyme announced that the Munich Regional Court has granted its application for a preliminary injunction to prevent MSD from distributing and offering for sale in Germany its Keytruda SC™ (pembrolizumab and berahyaluronidase alfa-pmph). The decision was based on a finding of the Court that there was imminent infringement of one of Halozyme’s European MDASE™ patents, EP 2797622, in relation to modified PH20 hyaluronidase polypeptides and compositions. It is not known whether MSD intends to appeal the decision.

According to the Wall Street Journal, MSD has issued a statement saying that MSD considers Halozyme’s patent “to be invalid globally and their allegation of infringement to be without merit”. MSD commenced legal proceedings against Halozyme’s ‘622 patent in the German Federal Patent Court in August 2025, alleging that it is invalid. MSD also filed a claim in the UK High Court of Justice in August 2025 seeking revocation of the ‘622 patent.

MSD’s subcutaneous (SC) formulation of Keytruda® was approved in Europe in November 2025, following a positive recommendation from the EMA’s CHMP in September 2025. The preliminary injunction in Germany will disrupt MSD’s launch plans in relation to Keytruda SC™ in that jurisdiction, although the IV presentation of Keytruda® will still be available.

Halozyme has also sued MSD in the US in relation to SC pembrolizumab (marketed as Keytruda Qlex™ in the US). In a complaint filed on 24 April 2025, Halozyme alleged that Keytruda Qlex™ infringes 15 patents owned by Halozyme in relation to the MDASE™ subcutaneous delivery platform. The lawsuit followed reports in March 2025 that Halozyme had offered MSD an opportunity to licence its MDASE patents. At the time, a spokesperson from MSD said the enzyme used in Keytruda Qlex™ was “developed independently” from Halozyme and that MSD “strongly believes” that any Halozyme patents that attempt to cover the enzyme variant are invalid.

MSD has filed petitions for post-grant review with the US Patent Trial and Appeal Board challenging the validity of 15 of Halozyme’s US patents. 14 petitions were filed between November 2024 and June 2025 and all have been instituted. The patents at issue are: US 11952600, US 12018298, US 12152262, US 12123035, US 12110520, US 12054758, US 12060590, US 12049652, US 12104185, US 12037618, US 12091692, US 12077791, US 12195773 and US 12264345. An additional petition was filed on 10 November 2025 in relation to US12371685 and is currently pending.

Fresenius/SCD’s Application for Biosimilar Aflibercept Accepted for Review by FDA

Dec 3, 2025

On 3 December 2025, Fresenius Kabi announced that the FDA has accepted for review Sam Chun Dang’s (SCD) application for its biosimilar aflibercept, SCD411. Under a December 2024 licensing agreement between Fresenius Kabi and SCD, Fresenius has the exclusive rights to commercialise the South Korean developed SCD411, biosimilar to Regeneron’s Eylea® (aflibercept), in the United States, Brazil, Argentina, Chile, Paraguay, Colombia, and Mexico.

SCD411 was approved in vial and pre-filled syringe (PFS) forms in Japan and Korea in September 2025, in Canada in June 2025 and in Europe in August 2025. At the time of the European approval, SCD considered it may be the first to launch a PFS aflibercept biosimilar in Europe, after being the first to do so in Canada. SCD reportedly licensed SCD411 to Apotex for the Canadian market (August 2023), to an unnamed distributor for Austria, Germany, Italy, Spain and Switzerland (November 2023), and to a further unnamed distributor for the UK, Belgium, Netherlands, Norway, Portugal, Sweden, Greece, Ireland and Finland (March 2024).

In July 2025, the Seoul Central District Court refused Regeneron/Bayer’s request for an order that SCD submit various documents and information in connection with a lawsuit alleging that SCD’s licence agreement with an unnamed overseas company to supply SCD411 constituted infringement of Regeneron’s Korean Patent 659477.

On 14 July 2025, Fresenius Kabi filed petitions for IPR (inter partes review) against Regeneron’s US Patent No. 11,084,865 to ophthalmic formulations of aflibercept and US Patent No. 10,828,345 to methods of treating angiogenic eye disorders. Fresenius is seeking to overturn claims 1-5, 7-30, and 32-50 of the 865 patent based on anticipation, and all claims of the 345 patent based on anticipation and obviousness. In November 2025, the PTAB denied institution of the IPR regarding the ‘865 patent on discretionary grounds (without reasons). Fresenius Kabi has sought review of that denial by way of a request filed in December 2025. The IPR regarding the ‘345 patent remains pending.

FDA Approves Celltrion’s 300mg Biosimilar Omalizumab

Dec 3, 2025

On 3 December 2025, Celltrion announced that it received FDA approval for a new 300 mg/2 mL pre-filled syringe presentation of Omlyclo®, biosimilar to Novartis’ Xolair® (omalizumab). The US approval follows EU approval of the same dosage form in November 2025.

Omlyclo® was first approved in the US in March 2025, in 75 mg/0.5ml and 150mg/ml PFS forms, with full interchangeable status. It has also been approved in the EU (May 2024), Korea (June 2024), Australia (November 2024), Canada (December 2024), and New Zealand (April 2025).

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, Latin America’s largest pharmaceutical market.

Aurobindo, Teva, Glenmark and Kashiv reportedly also have omalizumab biosimilars under development. On 11 August 2025, Kashiv BioSciences announced that it entered into a licence and supply agreement with Brazilian pharmaceutical company, CRISTÁLIA, for Kashiv’s biosimilar omalizumab, ADL-018, for the Latin American Market. Kashiv has previously entered into agreements for commercialisation of ADL-018 in other regions, including with MS Pharma for MENA markets (August 2025) and Alvotech for the EU, UK, Australia, Canada and New Zealand (AVT23, October 2023). A marketing application for AVT23 was accepted by the UK’s MHRA in March 2025.

Pearce IP BioBlast® for the week ending 28 November 2025

Dec 2, 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 28 November 2025 are set out below:

Aflibercept

2 December 2025 | AU | Regeneron/Bayer and Sandoz Settle Australian Aflibercept Proceedings
Regeneron/Bayer and Sandoz have settled Australian aflibercept patent infringement/revocation proceedings, with the Federal Court of Australia on 27 November… Read more here.

28 November 2025 | CA | Celltrion’s Biosimilar Aflibercept Approved in Canada
On 28 November 2025, Celltrion announced that Health Canada has approved its Eydenzelt®, biosimilar to Regeneron’s Eylea® (aflibercept), for all reference… Read more here.

24 November 2025 | IT | Formycon, Klinge & NTC Enter Exclusivity Agreement for Italian Aflibercept Biosimilar
On 24 November 2025, Formycon and Italian based pharmaceutical manufacturer NTC, jointly announced that Klinge Biopharma, the exclusive owner of the global… Read more here.

Denosumab

2 December 2025 | EU | European Commission Approves Denosumab Biosimilars for Alvotech, STADA, Dr. Reddy’s & Teva

On 24 November 2025, Alvotech announced that the European Commission has approved denosumab biosimilar, AVT03, in two presentations referencing Amgen’s… Read more here.

1 December 2025 | EU | Sandoz Launches First Denosumab Biosimilars in EU
On 1 December 2025, Sandoz announced the EU launch of Jubbonti® and Wyost®, biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively… Read more here.

1 December 2025 | US | Celltrion Signs Formulary Listing Agreements for Denosumab Biosimilars with Major US Pharmacy Benefit Managers
On 1 December 2025, Celltrion announced that it has signed a formulary listing contract with one of three undisclosed “major” US pharmacy benefit managers… Read more here.

Dupilumab

25 November 2025 | EU | New Indication Alert: EU Approves Sanofi/Regeneron’s Dupilumab for Chronic Spontaneous Urticaria
On 25 November 2025, Sanofi and Regeneron announced that the European Commission has approved an indication extension to Dupixent® (dupilumab) for… Read more here.

17 November 2025 | Formycon Announces Dupilumab Biosimilar in Development
On 17 November 2025, Formycon revealed that it is developing FYB208, a biosimilar candidate to Sanofi/Regeneron’s Dupixent® (dupilumab). According to Formycon… Read more here.

Ipilimumab

25 November 2025 | CN | Phase I Trials Underway for Henlius’ Ipilimumab Biosimilar
On 25 November 2025, Shanghai Henlius announced that the first subject has been dosed in a phase I multi-centre clinical trial of its ipilimumab biosimilar, HLX13… Read more here.

Omalizumab

25 & 27 November 2025 | BR | EU | Celltrion Launches First Omalizumab Biosimilar in Brazil & Completes Launch in Major EU Countries

On 27 November 2025, Celltrion announced that it has launched Omlyclo®, the first biosimilar to Novartis’ Xolair® (omalizumab) in Brazil, Latin America’s largest… Read more here.

Pembrolizumab

28 November 2025 | AU | Australia’s TGA Considers Indication Extension for MSD’s Pembrolizumab
On 28 November 2025, Australia’s TGA updated its online list of prescription medicines for evaluation for the months of September, October and November… Read more here.

Pertuzumab, Trastuzumab

27 November 2025 | IN | Intas’ Biosimilar to Phesgo® Approved for Phase I Trial
On 27 November 2025, India’s Medical Dialogues reported that Intas Pharmaceuticals has received approval in India to conduct a phase I trial comparing its INTP78… Read more here.

Secukinumab

28 November 2025 | KR | Novartis’ Cosentyx® (Secukinumab) Reimbursed for Hidradenitis Suppurativa in Korea
On 28 November 2025, Korea Biomedical Review reported that Novartis’ Cosentyx® (secukinumab) will be reimbursed in Korea from 1 December 2025… Read more here.

Trastuzumab

25 November 2025 | LATAM | Prestige & Biosidus Enter Exclusivity Agreement for Trastuzumab in LATAM
On 25 November 2025, Prestige Biopharma announced that it has entered into an exclusive license and supply agreement with Biosidus for the commercialisation… Read more here.

About Pearce IP

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

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.

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

Chantal Savage

Special Counsel, Lawyer

European Commission Approves Denosumab Biosimilars for Alvotech, STADA, Dr. Reddy’s & Teva

Dec 2, 2025

On 24 November 2025, Alvotech announced that the European Commission has approved denosumab biosimilar, AVT03, in two presentations referencing Amgen’s Prolia® and Xgeva®.

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

The next day, on 25 November 2025, Teva Pharmaceuticals announced that it also received European Commission approval for its two denosumab biosimilars, Ponlimsi® (referencing Prolia) and Degevma® (referencing Xgeva®).

The flurry of approvals follow the positive opinions adopted by the EMA’s CHMP in September 2025 for STADA’s, Dr Reddy’s and Teva’s denosumab products.

Sandoz’s Wyost® and Jubbonti® were the first denosumab biosimilars approved in Europe (May 2024), and on 1 December 2025, became the first to launch. There are a number of other denosumab biosimilars already approved in Europe although none have launched to date: Samsung Bioepis’ Obodence™ and Xbryk™ (February 2025), Celltrion’s Stoboclo® and Osenvelt® (February 2025), Accord Healthcare’s Jubereq® and Osvyrti® (May 2025); Gedeon Richter’s Junod® and Yaxwer®, mAbxience’s Izamby® and Denbrayce®, Biocon’s Evfraxy® and Vevzuo® (July 2025), Fresenius Kabi’s Conexxence® and Bomyntra® (July 2025) and Shanghai Henlius/Organon’s Bildyos® and Bilprevda® HLX14) (September 2025).

Regeneron/Bayer and Sandoz Settle Australian Aflibercept Proceedings

Dec 2, 2025

Regeneron/Bayer and Sandoz have settled Australian aflibercept patent infringement/revocation proceedings, with the Federal Court of Australia on 27 November 2025 dismissing all related proceedings by consent (VID715/2025; VID968/2025; VID1234/2025). The terms of the AU settlement have not otherwise been disclosed.

Regeneron and Bayer commenced proceedings against Sandoz on 4 June 2025 alleging infringement of Regeneron’s patent AU2012205599 relating to methods of treatment for angiogenic eye disorders, and separately sought preliminary discovery from Sandoz in relation to a second Regeneron aflibercept formulation/process patent, AU2020397865.

Regeneron/Bayer sought both a preliminary injunction (PI or interlocutory injunction) and final relief in respect of AU599, and Sandoz cross-claimed for invalidity. The PI application was heard on 14 August 2025 with Justice Rofe publishing her reasons for judgment on 8 September 2025, rejecting Regeneron/Bayer’s application. Rofe J found there was an “insufficient likelihood of success” that Regeneron/Bayer’s infringement case would succeed at a final hearing and that the balance of convenience did not favour the grant of the interlocutory injunction.

Regeneron moved swiftly to appeal her Honour’s decision, with the Full Court hearing the appeal on 29 October 2025. However, the proceedings were settled the day that judgment was due to be delivered, with no decision being handed down.

Regeneron and Bayer’s ‘599 patent remains the subject of revocation proceedings in Australia. In August 2025, Actor Pharmaceuticals, which does not yet have any aflibercept biosimilar approved in Australia, filed proceedings in the Federal Court seeking to invalidate AU599, with the first case management hearing in that matter heard on 2 December 2025. In that first case management hearing, Regeneron’s counsel represented that it is also considering whether to involve the ‘865 patent and bring preliminary discovery proceedings. Actor’s aflibercept product remains under evaluation by the TGA and is not yet approved.

On 9 September 2025, Sandoz announced that it settled all US patent disputes between it and Regeneron relating to Sandoz’s Enzeevu® (aflibercept). Under the terms of the US settlement, Sandoz is permitted to launch its biosimilar aflibercept in the US in Q4 2026, or earlier in certain undisclosed circumstances.

Positive CHMP Opinion for Samsung Bioepis’ PFS Presentation of Biosimilar Ranibizumab

Dec 2, 2025

On 2 December 2025, Samsung Bioepis announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for Byooviz® pre-filled syringe (PFS), biosimilar to Genentech’s Lucentis® (ranibizumab).

The positive CHMP opinion follows Samsung Bioepis’ announcement in October 2025 that it had entered into an Asset Purchase Agreement with Biogen in Europe for Samsung Bioepis’ two ophthalmology biosimilars: Byooviz® (ranibizumab) and Opuviz™ (biosimilar to Regeneron/Bayer’s Eylea® (aflibercept)).

Samsung Bioepis and Biogen had partnered in November 2019 in relation to commercialisation of the two ophthalmology biosimilars in the US, Canada, Europe, Japan and Australia. In October 2024, Biogen decided to terminate the November 2019 agreement with Samsung Bioepis within the US and Canada. In July 2025, Samsung Bioepis entered into an agreement with Harrow, under which Harrow assumes full commercial responsibility for Byooviz® and Opuviz™ in the US upon full transition of Biogen’s commercialisation rights back to Samsung Bioepis by the end of 2025.

Under the Asset Purchase Agreement announced in October 2025, Samsung Bioepis is responsible for commercialising Byooviz® in Europe from January 2026 once the transfer of commercial rights from Biogen back to Samsung Bioepis takes effect. Samsung Bioepis will launch Opuviz™ in Europe following the lapse or revocation of relevant patent(s) for Eylea®.

Byooviz® has been commercially available in several European countries since March 2023, following its approval in August 2021 (in vial form) as the first ophthalmology biosimilar in the region for the treatment of patients with nAMD, macular oedema following retinal vein occlusion (RVO), and myopic choroidal neovascularisation (mCNV). Other EU approved ranibizumab biosimilars include Formycon’s Ranivisio® (approved August 2022, being commercialised in the EU by Teva), Lupin’s biosimilar (being marketed in the EU by Sandoz); and STADA/Xbrane’s Ximluci® (approved November 2022).

Celltrion’s Remsima SC First to LATAM Market

Dec 2, 2025

On 2 December 2025, Celltrion announced that it has launched Remsima® SC (infliximab) in Chile, marking the biosimilar’s first entrance into the public market in Central and South America.

Remsima® SC was first listed on the Chilean public insurance plan in April 2025 and Celltrion Chile has recently completed its first sales following negotiations with the local public procurement agency, CENABAST. According to Celltrion, the public market accounts for 80% of pharmaceutical product sales in Latin America.

Celltrion’s Remsima®, biosimilar to Janssen’s Remicade® (infliximab), has been approved in Europe since 2013 and was launched in major European countries in early 2015. Subcutaneous infliximab (Remsima™ SC) first received European approval in November 2019 and was launched in the EU in 2020. In February 2024, Celltrion launched Remsima SC® as Zymfentra® in the US. In November 2025, Celltrion announced that its Remsima® IV liquid formulation was approved in Europe.

Biocon Secures EU/ROW Deal for Biosimilar Denosumab Following Amgen Settlement, Launch in EU in December 2025

Dec 2, 2025

On 2 December 2025, Biocon announced that it has reached a settlement and licence with Amgen for Europe and ROW, permitting Biocon to launch its Evfraxy® and Vevzuo®, biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), in Europe from 2 December 2025. The settlement follows a US settlement between the companies resolving pending BPCIA denosumab patent litigation and permitting Biocon’s 1 October 2025 US launch of Bosaya™ and Aukelso™. The dates Biocon is licensed to commercialise denosumab biosimilars in ROW remain confidential.

Biocon’s Evfraxy® and Vevzuo® received European and UK approval in July 2025. Sandoz’s Wyost® and Jubbonti® were the first denosumab biosimilars approved in Europe (May 2024), and were launched on 1 December 2025. European launches of denosumab biosimilars of the following sponsors were also announced on 1-2 December 2025: Samsung Bioepis’ Obodence™ and Xbryk™ (approved February 2025), Accord Healthcare’s Osvyrti® and Jubereq® (approved May 2025), Zentiva’s Zadenvi® (approved June 2025), and Fresenius Kabi’s Conexxence® and Bomyntra® (approved July 2025).

EU Denosumab Biosimilar Competition Heats Up with Launches from Fresenius, Samsung Bioepis, Accord & Zentiva

Dec 2, 2025

On 1 and 2 December 2025, European launches of denosumab biosimilars were announced by the following sponsors:

Fresenius Kabi announced the 1 December launch of Conexxence® and Bomyntra® (EU approved in July 2025), biosimilars to Amgen’s Prolia® and Xgeva® respectively;
Samsung Bioepis announced that Obodence™ (60mg PFS, referencing Prolia®) will be available in Europe from December 2025, with Xbryk™ (120 mg vial, referencing Xgeva®) to follow in January 2026. Obodence™ and Xbryk™ were approved by the European Commission in February 2025;
Zentiva announced the 1 December launch of its denosumab biosimilar, its first entry into the biosimilar market. Zentiva’s Zadenvi®, referencing Prolia®, was approved in Europe in June 2025; and
Accord Healthcare announced the 2 December launches of Osvyrti® and Jubereq® (EU approved May 2025), biosimilars to Prolia® and Xgeva® respectively.

Sandoz’s Jubbonti® and Wyost® (denosumab) were also launched on 1 December 2025, as previously reported here.

In addition, Biocon announced a settlement agreement with Amgen, permitting Biocon to commercialise Evfraxy® and Vevzuo® (approved July 2025) in Europe from 2 December 2025.

There are a number of other denosumab biosimilars already approved in Europe which are yet to launch: Gedeon Richter’s Junod® and Yaxwer® and mAbxience’s Izamby® and Denbrayce® (July 2025), Shanghai Henlius/Organon’s Bildyos® and Bilprevda® HLX14) (September 2025), Alvotech/STADA’s Kefdensis® and Zvogra® and Alvotech/Dr. Reddy’s Acvybra® and Xbonzy® (both in November 2025), and Teva’s Ponlimsi® and Degevma® (also November 2025).

Celltrion Signs Formulary Listing Agreements for Denosumab Biosimilars with Major US Pharmacy Benefit Managers

Dec 1, 2025

On 1 December 2025, Celltrion announced that it has signed a formulary listing contract with one of three undisclosed “major” US pharmacy benefit managers (PBM) for its denosumab biosimilars, Stoboclo® and Osenvelt®, referencing Amgen’s Prolia® and Xgeva®, respectively.

Under the agreement, Stoboclo® and Osenvelt® will be listed on all public and private insurance formularies operated by the PBM, and will also secure preferred drug status, enabling priority prescribing. Celltrion states that patient reimbursement will be available from January 2026. According to Celltrion, it is also pursuing transitional formulary listing agreements with the two undisclosed other “major” PBMs.

Additionally, Celltrion also announced that it has signed a listing contact with the fifth-largest PBM in the US for Stoboclo® and Osenvelt®, also resulting in the products being listed as a preferred drug on all public and private insurance formularies operated by the PBM.

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 settled in January 2025, supporting the US launch of Celltrion’s denosumab biosimilars in July 2025.

There are seven pairs of denosumab biosimilars approved in the US: Sandoz’s Jubbonti® and Wyost® (approved March 2024, launched June 2025), Samsung Bioepis’ Obodence™ and Xbryk™ (approved February 2025, not yet launched), Celltrion’s Stoboclo® and Osenvelt® (approved March 2025, launched July 2025), Fresenius Kabi’s Conexxence® and Bomyntra® (approved March 2025, launched July 2025), Shanghai Henlius/Organon’s Bildyos® and Bilprevda® (approved September 2025, not yet launched), Biocon’s Bosaya™ and Aukelso™ (approved September 2025, launched October 2025), and Richter/Hikma’s Enoby™and Xtrenbo™ (approved September 2025, not yet launched).

Sandoz Launches First Denosumab Biosimilars in EU

Dec 1, 2025

On 1 December 2025, Sandoz announced the EU launch of Jubbonti® and Wyost®, biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively. Jubbonti® and Wyost® were approved for all reference indications by the European Commission (EC) in May 2024, and are the first and only denosumab biosimilars to be launched in the EU.

The EU launch comes 6 months after the US launch of Jubbonti® and Wyost® in June 2025, which followed a settlement agreement entered into by Sandoz and Amgen in April 2024 resolving US patent infringement litigation commenced by Amgen in May 2023 and permitting US launch of Jubbonti® and Wyost® from 31 May 2025.

There are a number of other denosumab biosimilars approved in Europe, although none have launched to date: Samsung Bioepis’ Obodence™ and Xbryk™ (February 2025), Celltrion’s Stoboclo® and Osenvelt® (February 2025), Accord Healthcare’s Jubereq® and Osvyrti® (May 2025); Gedeon Richter’s Junod® and Yaxwer®, mAbxience’s Izamby® and Denbrayce®, Biocon’s Evfraxy® and Vevzuo® (July 2025), Fresenius Kabi’s Conexxence® and Bomyntra® (July 2025), Shanghai Henlius/Organon’s Bildyos® and Bilprevda® HLX14) (September 2025), Alvotech’s AVT03 (marketed as Kefdensis® and Zvogra® by STADA; marketed as Acvybra® and Xbonzy® by Dr Reddy’s; November 2025) and Teva’s Ponlimsi™ and Degevma™ (November 2025).

The EC’s CHMP has also issued positive opinions for Intas’ Denosumab Intas (referencing Prolia®) (September 2025) and Enzene/Theramex’s Osqay® (referencing Prolia®) (November 2025).

Express Scripts adds Accord Biosimilar Ustekinumab to Formularies

Dec 1, 2025

On 1 December 2025, Accord BioPharma announced that Express Scripts has added Imuldosa®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), to its largest commercial formularies, including National Preferred Formulary, starting 5 September 2025. Express Scripts is one of the United States’ largest pharmacy benefit managers. Accord’s announcement follows the commercial launch of Imuldosa® in the US in August 2025.

Imuldosa® was FDA-approved in October 2024. It was jointly developed by Dong-A St and Meiji Seika Pharma, which granted Intas Pharmaceuticals (Accord’s parent company) exclusive licensing rights worldwide, excluding certain Asian countries, in an agreement announced in 2021. Under the agreement, Accord is responsible for US commercialisation.

There are a number of ustekinumab biosimilars already launched in the US: Amgen’s Wezlana® (January 2025), Alvotech/Teva’s Selarsdi® (February 2025), Samsung Bioepis/Sandoz’s Pyzchiva® (February 2025), Biocon’s Yesintek® (February 2025), Formycon/Fresenius Kabi’s Otulfi® (March 2025), Celltrion’s Steqeyma® (March 2025) and Hikma’s Starjemza™ (November 2025).

Novartis’ Cosentyx® (Secukinumab) Reimbursed for Hidradenitis Suppurativa in Korea

Nov 28, 2025

On 28 November 2025, Korea Biomedical Review reported that Novartis’ Cosentyx® (secukinumab) will be reimbursed in Korea from 1 December 2025 for adult patients with severe hidradenitis suppurativa who show an inadequate response to standard systemic therapy.

According to Korea Biomedical Review, reimbursement applies to adults who received an initial diagnosis of hidradenitis suppurativa at least one year earlier, have lesions in two or more distinct anatomical areas with a combined total of at least three abscesses or inflammatory nodules, and have undergone antibiotic therapy for three months or longer without meaningful improvement or were forced to discontinue due to adverse events.

In September 2025, Novartis announced plans to launch a US direct-to-patient (DTP) platform for Cosentyx® (secukinumab) from November 2025, offering cash-paying patients access to the drug at 55% off the list price.

There are a number of secukinumab biosimilars currently under development, including by Celltrion (phase 1 clinical trial completed; global phase 3 trial for CT-P55 in plaque psoriasis approved by the FDA in August 2024), Bio-Thera (phase 3 clinical trial of BAT2306 in plaque psoriasis completed in 2024, and phase 1 trial completed in 2023), Taizhou Mabtech Pharmaceutical (phase 1 trial of CMAB015 completed in 2023) and Livzon Pharmaceutical Group (phase 3 clinical trial of LZM012 in plaque psoriasis currently recruiting).

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