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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 19 September 2025

Sep 23, 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 19 September 2025 are set out below:

Aflibercept

21 September 2025 | IN | CA | Biocon’s Biosimilar Aflibercept Recommended in India; Publicly Funded in Canada

18 September 2025 | AU | Samsung Bioepis’ Aflibercept Biosimilar Third to be Approved in Australia

On 18 September 2025, Samsung Bioepis’ Opuviz®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept 2mg), was approved by Australia’s Therapeutic Goods Administration (TGA) in 2 presentations… Read more here.

17 September 2025 | AU | Regeneron/Bayer Appeal Australian Court’s Refusal to Grant PI and Prevent Launch of Sandoz’s Biosimilar Aflibercept

17 September 2025 | US | Alvotech Files US PGR Challenging Regeneron’s Method of Treatment Patent for High Dose Aflibercept

On 17 September 2025, Alvotech filed a petition for post grant review of Regeneron’s patent… Read more here.

17 September 2025 | EU | Alteogen’s Biosimilar Aflibercept EU Approved

On 17 September 2025, Alteogen announced that the European Commission has approved Eyluxvi® (ALT-L9), biosimilar to Regeneron/Bayer’s Eylea® (aflibercept)… Read more here.

17 September 2025 | EU | Formycon/Klinge’s Biosimilar Aflibercept to be Commercialised by Horus Pharma in EU

Denosumab

19 September 2025 | EU | European Commission Approves Shanghai Henlius/Organon’s Denosumab Biosimilars

On 19 September 2025, Shanghai Henlius and Organon announced that the European Commission has approved Bildyos® and Bilprevda® (HLX14)… Read more here.

19 September 2025 | CuraTeQ Announces Positive Ph 3 Results for Biosimilar Denosumab

On 19 September 2025, Aurobindo Pharma subsidiary, CuraTeQ Biologics, announced positive results from its Phase 3 trial of BP16… Read more here.

18 September 2025 | CA | Celltrion’s Denosumab Biosimilars Second to be Approved in Canada

On 18 September 2025, Celltrion announced that Health Canada has granted approval for Stoboclo® and Osenvelt® (CT-P41), biosimilars to Amgen’s… Read more here.

17 September 2025 | US | FDA Approves Biocon’s Denosumab Biosimilars Bosaya™ and Aukelso™

On 17 September 2025, Biocon Biologics announced that it received FDA approval for denosumab products Bosaya™ and Aukelso™, biosimilars to Amgen’s… Read more here.

Golimumab, Denosumab, Ustekinumab

19 September 2025 | EU | Positive CHMP Opinions for 9 Biosimilars – Good News for Alvotech, Advanz, STADA, Dr Reddy’s, Teva, Intas & Bio-Thera

On 19 September 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) published the outcomes of its September meeting… Read more here.

Golimumab, Denosumab, Aflibercept

19 September 2025 | JP | Alvotech/Fuji Pharma’s JP Golimumab Biosimilar First Approved Worldwide; Aflibercept & Denosumab Biosimilars Also JP Approved

On 19 September 2025, Alvotech announced that Fuji Pharma, its commercialisation partner in Japan, has received approval from the Japanese Ministry of Health, Labour and Welfare for 3 biosimilars … Read more here.

Omalizumab

19 September 2025 | NO | Celltrion Launches Biosimilar Omalizumab in Norway; Presents Ph 3 Results from Switching Study

On 19 September 2025, Celltrion announced that it will begin the European launch of Omlyclo®, biosimilar to Genentech’s Xolair® (omalizumab), in Norway… Read more here.

Pembrolizumab

19 September 2025 | US | EU | MSD’s Subcutaneous Keytruda® (Pembrolizumab) Approved in US & Recommended in EU

On 19 September 2025, MSD announced that Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph; MK-3475A) has been approved by the FDA for subcutaneous use in adults… Read more here.

Secukinumab

15 September 2025 | MENA | Bio-Thera & Jamjoom Pharma Partner on Secukinumab Biosimilar in MENA

On 15 September 2025, Bio-Thera and Saudi Arabia-headquartered Jamjoom Pharmaceuticals Factory Company announced they have entered a strategic commercialisation… Read more here.

Tocilizumab

22 September 2025 | JP | Celltrion’s Biosimilar Tocilizumab First to be Approved in Japan

On 22 September 2025, Celltrion announced that Japan’s Ministry of Health, Labor and Welfare has approved Avtozma®/CT-P47, biosimilar to Roche’s Actemra® … Read more here.

Ustekinumab

16 September 2025 | JP | Mitsubishi Tanabe’s Co-Promotion of Janssen’s Stelara® to End on 31 December 2025 in Japan

On 16 September 2025, First Word Pharma reported that Mitsubishi Tanabe Pharma Corporation’s (MTPC) contract with Janssen for co-promotion activities for Janssen’s Stelara®… Read more here.

10 September 2025 | NL | Dutch Court Validates Janssen’s Ustekinumab Patent for Treating UC

On 10 September 2025, the District Court of The Hague delivered judgment in Samsung Bioepis’ revocation action against Janssen’s EP 3 883 606 (the Janssen Patent)… 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.

Subcutaneous Nivolumab Recommended for Reimbursement in Canada for Solid Tumour Indications

Sep 23, 2025

On 23 September 2025, Bristol Myers Squibb announced that the Institut national d’excellence en santé et en services sociaux (INESSS) has issued a positive recommendation for the reimbursement of Opdivo® SC (nivolumab for subcutaneous injection) in Quebec across Health Canada-authorised solid tumour indications where Opdivo® (nivolumab) for intravenous infusion is reimbursed.

Opdivo® SC was approved for solid tumour indications in Canada and the EU in May 2025, following similar approvals in the US (December 2024) and UK (April 2025).

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

First Canakinumab Biosimilar Approved in Russia

Sep 23, 2025

On 23 September 2025, GxP News reported that Russian company, Generium, has obtained registration of the first Russian biosimilar to Novartis’ Ilaris® (canakinumab). The biosimilar, Limiris™, has been approved as a lyophilised powder for subcutaneous injection and is indicated for the treatment of Still’s disease, systemic juvenile idiopathic arthritis, autoinflammatory diseases, and gouty arthritis.

Generium offers a number of biosimilar products in Russia including Elizaria®, biosimilar to Alexion’s Soliris® (eculizumab) (approved April 2019) and Genolar®, biosimilar to Genentech’s Xolair® (omalizumab) (approved February 2022).

There have not been any reports of canakinumab biosimilars approved elsewhere. However, in May 2025, Alvotech and Advanz expanded their partnership to include the development and commercialisation of a canakinumab biosimilar in Europe.

Sam Chun Dang’s Biosimilar Aflibercept Approved in Japan and Korea

Sep 23, 2025

On 23 September 2025, Korea Biomedical Review reported that Sam Chun Dang’s SCD411, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), was approved in both Japan and Korea in vial and pre-filled syringe (PFS) forms.

The latest approvals follow SCD411’s Canadian approval on 26 June 2025 and European approval in August 2025, also in vial and PFS forms. 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.

Alvotech/Fuji Pharma received Japanese approval for biosimilar aflibercept (AVT06) earlier this month (September 2025). In Korea Samsung Bioepis’ Afilivu® (SB15) (February 2024) andCelltrion’s Eydenzelt® (CT-P42) (May 2024) have been approved.

Celltrion’s Biosimilar Tocilizumab First to be Approved in Japan

Sep 22, 2025

On 22 September 2025, Celltrion announced that Japan’s Ministry of Health, Labor and Welfare has approved Avtozma®/CT-P47, biosimilar to Roche’s Actemra® (tocilizumab), for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), Castleman disease (CD), and cytokine release syndrome (CRS).

This marks the first tocilizumab biosimilar approved in Japan, with Celltrion planning to launch “quickly” to secure “first mover advantage”.

In May 2025, Avtozma® became the first approved tocilizumab biosimilar in Australia. 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).

Enzene’s Pertuzumab Biosimilar Launched in India

Sep 22, 2025

On 22 September 2025, Enzene Biosciences announced the Indian launch of its biosimilar to Roche’s Perjeta® (pertuzumab). According to Enzene, the biosimilar is being marketed in India by “multiple leading pharmaceutical companies”. This includes Enzene’s parent company, Alkem Laboratories, which is marketing the biosimilar under the name Pertuza®, and Hetero Healthcare, which has announced the launch of the Enzene biosimilar under the name Perzea®.

Other pertuzumab biosimilars approved in India include Intas’ biosimilar (approved December 2024) and Zydus’ Sigrima™ (approved June 2024). Sigrima™ is the subject of legal action in India by Roche, which is alleging infringement of patents IN268632 and IN464646.

Roche has recently indicated that biosimilar competition to Perjeta® is a bigger concern than it previously anticipated. As well as the Indian proceedings against Zydus, Roche has also sued Shanghai Henlius and Organon in the US, alleging that their pertuzumab biosimilar, HLX11, infringes multiple US patents.

Amgen’s High-Concentration Adalimumab Biosimilar AU Approved

Sep 22, 2025

On 22 September 2025, Australia’s Therapeutic Goods Administration approved Amgen’s high-concentration Amgevita® (100mg/ml), biosimilar to AbbVie’s Humira® (adalimumab), in the following presentations:

20mg/0.2mL (484565) and 40mg/0.4mL (484554) injection solution syringe; and
40mg/0.4mL (484553) and 80mg/0.8mL (486685) injection solution syringe with a pen injector.

There are a number of other high-concentration adalimumab biosimilars approved in Australia, including Celltrion’s Yuflyma® (March 2022), Alvotech/Cipla’s Ciptunex®/Adalicip® (September 2022), Samsung Bioepis’ Hadlima® (February 2023) and Sandoz’s Hyrimoz® (May 2024).

In March 2025, Sandoz’s high-concentration Hyrimoz® (80 mg/0.8 mL injection, 0.8 mL pen) was PBS listed for all Humira® indications, which followed PBS-listing of the 40 mg/0.4 mL injection, 2 x 0.4 mL pen presentation in January 2025.

Biocon’s Biosimilar Aflibercept Recommended in India; Publicly Funded in Canada

Sep 21, 2025

On 21 September 2025, Medical Dialogues reported that Biocon has received recommendations from India’s Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) to import and market its biosimilar to Regeneron/Bayer’s Eylea® (aflibercept) in India for multiple ophthalmic indications (in 40mg/ml vial form for injection). Biocon is required to submit a Phase IV (post-marketing) clinical trial protocol to the CDSCO within 3 months of the grant of marketing authorisation.

Biocon also announced on 18 September 2025 that Yesafili® (aflibercept), in vial and prefilled syringe presentations, is now publicly funded on the Ontario Drug Benefit Formulary/Comparative Drug Index for the advanced treatment of patients with retinal diseases.

Yesafili® was reported to be the first aflibercept biosimilar approved in Canada in June 2025 and was launched in July 2025 under a March 2024 settlement between Biocon and Regeneron/Bayer.

Biocon’s Yesafili® was approved in Europe in September 2023 but is not yet on the market. In April 2025, Biocon and Regeneron settled US BPCIA litigation regarding aflibercept, paving the way for a US launch of Yesafili® in the second half of 2026, or earlier under certain undisclosed circumstances.

MSD’s Subcutaneous Keytruda® (Pembrolizumab) Approved in US & Recommended in EU

Sep 19, 2025

On 19 September 2025, MSD announced that Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph; MK-3475A) has been approved by the FDA for subcutaneous use in adults across 38 indications, covering most solid tumour indications for Keytruda® (pembrolizumab). MSD is planning a late September 2025 US launch for Keytruda Qlex™.

According to Business Korea, if Keytruda Qlex™ successfully penetrates the market, Alteogen, the developer of hyaluronidase technology used with the subcutaneous formulation, is expected to generate annual royalty income exceeding 1 trillion won.

The FDA had accepted MSD’s BLA for SC pembrolizumab in March 2025, with a target action date of 23 September 2025.

The good news for MSD comes a day after the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended a change to the marketing authorisation for MSD’s Keytruda®, adopting a new pharmaceutical form, solution for injection, associated with two new strengths (790 mg and 305 mg), together with subcutaneous use as a new route of administration.

MSD was sued by Halozyme in the US on 24 April 2025 in relation to SC pembrolizumab, with Halozyme alleging that it infringes 15 patents owned by Halozyme in relation to 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 SC Keytruda® was “developed independently” from Halozyme and that MSD “strongly believe” that any Halozyme patents that attempt to cover the enzyme variant are invalid.

MSD has filed 14 petitions for post-grant review with the US Patent Trial and Appeal Board challenging the validity of US patents owned by Halozyme, a number of which are asserted in the litigation. The petitions were filed between November 2024 and June 2025. Petitions in relation to 5 patents have been instituted (US 11952600 (2 June 2025), US 12018298 (11 June 2025), US 12152262 (16 June 2025), US 12123035 (11 July 2025), US 12110520 (8 September 2025)), while others are pending.

Celltrion Launches Biosimilar Omalizumab in Norway; Presents Ph 3 Results from Switching Study

Sep 19, 2025

On 19 September 2025, Celltrion announced that it will begin the European launch of Omlyclo®, biosimilar to Genentech’s Xolair® (omalizumab), in Norway. The announcement comes only 9 days after Celltrion said that it was set to “launch in Europe as a ‘first mover’ within the year”.

On the same date, Celltrion also announced results from its global Phase 3 clinical trial of Omlyclo®, involving 619 patients with chronic spontaneous urticaria. Starting from week 12, patients who received Omlyclo® were continued on the same treatment and patients who initially received 300mg of the reference product were re-randomised in a 1:1 ratio to either switch to Omlyclo® or to continue receiving the reference product. The results demonstrated comparable efficacy and safety to the reference product.

Omlyclo® is approved in the EU (May 2024), Korea (June 2024), Australia (November 2024), Canada (December 2024), the US (March 2025) and New Zealand (April 2025). The Celltrion product has been the subject of patent infringement actions in at least the UK and Europe.

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.

Alvotech/Fuji Pharma’s JP Golimumab Biosimilar First Approved Worldwide; Aflibercept & Denosumab Biosimilars Also JP Approved

Sep 19, 2025

On 19 September 2025, Alvotech announced that Fuji Pharma, its commercialisation partner in Japan, has received approval from the Japanese Ministry of Health, Labour and Welfare for 3 biosimilars:

Golimumab: AVT05 (GOLIMUMAB BS 50 mg PFS for subcutaneous injection), biosimilar to Janssen’s Simponi®;
Denosumab: AVT03 (DENOSUMAB BS 120 mg/1.4 mL in a vial for subcutaneous injection), biosimilar to Daiichi Sankyo’s Ranmark®, which is marketed in other countries as Amgen’s Xgeva®; and
Aflibercept AVT06 (AFLIBERCEPT BS 40 mg/mL solution in PFS for IV injection and 40 mg/mL vial kit for IV injection), biosimilar to Regeneron/Bayer’s Eylea®.

Alvotech considers that the Japanese approval of AVT05 is the first golimumab biosimilar approval in any major market. Alvotech/Fuji’s AVT04, biosimilar to J&J’s Stelara®, was the first ustekinumab biosimilar approved in Japan in September 2023.

Alvotech and Fuji Pharma first announced they had entered into a commercialisation agreement for Japan in 2018, with the agreement expanded in February 2022 and January 2023. The agreement covers the four approved biosimilars, plus two unnamed biosimilar candidates currently under development.

In January 2025, Celltrion announced plans to launch its denosumab (CT-P41) and aflibercept (CT-P42) biosimilars in Japan during 2025, together with ustekinumab (CT-P43), omalizumab (CT-P39) and tocilizumab (CT-P47) biosimilars.

Positive CHMP Opinions for 9 Biosimilars – Good News for Alvotech, Advanz, STADA, Dr Reddy’s, Teva, Intas & Bio-Thera

Sep 19, 2025

On 19 September 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) published the outcomes of its September meeting, adopting positive opinions for the following nine biosimilars:

Golimumab: Alvotech/Advanz Pharma’s Gobivaz® (AVT05), biosimilar to J&J’s Simponi® (golimumab). In November 2024, Alvotech/Advanz Pharma’s European MAA for AVT05 was the first golimumab biosimilar MAA to be accepted anywhere in the world;
Denosumab: STADA/Alvotech’s Kefdensis® and Zvogra® (AVT03, MAA accepted October 2024), Dr Reddy’s Acvybra® and Xbonzy®, and Teva’s Ponlimsi™ and Degevma™ (TVB-009P, MAA accepted October 2024), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) and Intas’ Denosumab Intas, biosimilar to Amgen’s Prolia® (denosumab);
Ustekinumab: Bio-Thera/STADA’s Usgena™ (BAT2506), biosimilar to J&J/Janssen’s Stelara® (ustekinumab). Bio-Thera and STADA entered an exclusive commercialisation agreement in relation to BAT2506 in May 2024 under which Bio-Thera has responsibility for development and manufacturing the biosimilar while STADA has exclusive commercialisation rights in the EU, UK, Switzerland and certain other countries.

There are currently 8 sponsors with denosumab biosimilars approved in Europe although none have launched to date: Sandoz’s Wyost® and Jubbonti® (May 2024), Samsung Bioepis’ Obodence™ and Xbryk™ (February 2025), Celltrion’s Stoboclo® and Osenvelt® (February 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). Accord Healthcare’s Jubereq® and Osvyrti® received CHMP positive opinions in March 2025.

There are no golimumab biosimilars approved in the EU, so Alvotech is likely to have the first EU approved biosimilar golimumab. Following acceptance of Alvotech/Advanz’s MAA for AVT05 in November 2024, Bio-Thera/STADA’s MAA for BAT2506 was accepted by the EMA in February 2025.

There are a number of ustekinumab biosimilars now marketed in EU, with STADA/Alvotech’s Uzpruvo® and Sandoz’s Pyzchiva® launched in July 2024 and Celltrion’s Steqeyma® launched in November 2024. Approved ustekinumab biosimilars in Europe include Amgen’s Wezenla™ (June 2024), Samsung Bioepis’ Eksunbi™ (September 2024), Fresenius’ Otulfi®/FYB202 and Formycon’s Fymskina® (September 2024), Accord’s Imuldosa® and Absimky® (December 2024) and Biocon’s Yesintek® (February 2025).

CuraTeQ Announces Positive Ph 3 Results for Biosimilar Denosumab

Sep 19, 2025

On 19 September 2025, Aurobindo Pharma subsidiary, CuraTeQ Biologics, announced positive results from its Phase 3 trial of BP16, biosimilar to Amgen’s Prolia® (denosumab).

The study, which was conducted across 40 sites in five European countries on 446 postmenopausal women, evaluated the biosimilar’s efficacy in improving bone mineral density (BMD) and reducing fracture risk. The trial met all clinical endpoints, showing no clinically meaningful differences between the biosimilar and the reference product.

According to the announcement, CuraTeQ plans to begin regulatory submissions for BP16 in the EU, US, and other key regions from January 2026.

In April 2025, CuraTeQ reported successful Phase I results for BP16, which included 204 subjects from Australia and New Zealand, demonstrating comparable safety, pharmacodynamics and immunogenicity profiles to both the European and US versions of Prolia®.

European Commission Approves Shanghai Henlius/Organon’s Denosumab Biosimilars

Sep 19, 2025

On 19 September 2025, Shanghai Henlius and Organon announced that the European Commission has approved Bildyos® and Bilprevda® (HLX14), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) respectively, for all reference indications.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Bildyos® and Bilprevda® in July 2025, following the acceptance of the marketing authorisation application by the European Medicines Agency in May 2024.

Shanghai Henlius entered into a licence agreement with Organon in June 2022 under which Organon has exclusive global commercialisation rights to HLX14 (denosumab) for all countries except China, Hong Kong, Macau and Taiwan.

In June 2025, Amgen sued Henlius and Organon in the US in relation to their denosumab biosimilars, alleging infringement of 26 US patents covering denosumab, pharmaceutical compositions of denosumab, methods of manufacturing therapeutic proteins, like denosumab, and denosumab products. Amgen also has pending BPCIA litigation against Hikma/Gedeon Richter and Biocon in relation to denosumab. On 16 July 2025, BPCIA litigation involving Accord/Intas and Amgen was concluded following a settlement between the parties permitting Accord/Intas to launch its denosumab biosimilars in the US after 1 October 2025.

There are now 8 sponsors with denosumab biosimilars approved in the EU, although none have been launched to date, with previous approvals for: Sandoz’s Wyost® and Jubbonti® (May 2024), Samsung Bioepis’ Obodence™ and Xbryk™ (February 2025), Celltrion’s Stoboclo® and Osenvelt® (February 2025), Gedeon Richter’s Junod® and Yaxwer®, mAbxience’s Izamby® and Denbrayce®, Biocon’s Evfraxy® and Vevzuo® (July 2025) and Fresenius Kabi’s Conexxence® and Bomyntra® (July 2025).

New Indication Alert: FDA Approves J&J’s Subcutaneous Guselkumab for UC

Sep 19, 2025

On 19 September 2025, Johnson & Johnson announced that the FDA has approved a subcutaneous (SC) induction regimen of Tremfya® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC). The BLA for the SC regimen was accepted in November 2024 and followed the approval of Tremfya® with intravenous (IV) induction for UC in September 2024.

In March 2025, the FDA approved Tremfya® for the treatment of moderately to severely active Crohn’s disease in adults. With the latest approval, Tremfya® is the first and only IL-23 inhibitor to offer both SC and IV induction options for the treatment of UC and Crohn’s disease in the US.

Tremfya® was approved by the UK’s MHRA for treatment of Crohn’s disease and UC in May 2025 and has been approved for the same indications in the EU (Crohn’s, May 2025; UC, April 2025).

Biosimilar development of guselkumab is underway. In September 2025, Polpharma and MS Pharma announced that they entered into a licensing agreement for the commercialisation of PB019, biosimilar guselkumab, in the Middle East and North Africa (MENA) region. In 2023, Alvotech and Advanz Pharma entered into a partnership agreement to commercialise a proposed guselkumab biosimilar in the EU, UK and Switzerland.

Celltrion’s Denosumab Biosimilars Second to be Approved in Canada

Sep 18, 2025

On 18 September 2025, Celltrion announced that Health Canada has granted approval for Stoboclo® and Osenvelt® (CT-P41), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively, for all reference indications.

This makes Celltrion’s Stoboclo® and Osenvelt® the second pair of denosumab biosimilars approved in Canada, following Sandoz’s Wyost® (approved February 2024) and Jubbonti® (approved March 2024), which were launched in August 2024.

Celltrion’s denosumab biosimilars have been approved in various regions, including: Korea (approved November 2024, launched March 2025), Europe (approved February 2025, not yet launched), the US (approved March 2025, launched July 2025) and Australia (approved April 2025, not yet launched).

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.

Samsung Bioepis’ Aflibercept Biosimilar Third to be Approved in Australia

Sep 18, 2025

OPUVIZ aflibercept 40 mg/mL solution for intravitreal injection in vial (456527)
OPUVIZ aflibercept 40 mg/mL solution for intravitreal injection in vial with needle (456528)

The PI for Opuviz® is not yet available.

With this approval, Samsung Bioepis becomes the third sponsor with an approved aflibercept biosimilar in Australia. Celltrion’s Eydenzelt® was the first aflibercept biosimilar TGA-approved on 31 March 2025 (solely for myopic CNV), which was followed by Sandoz’s Afqlir® and Enzeevu® on 27 May 2025. Sandoz’s products were the first aflibercept biosimilars to be considered and recommended for listing on Australia’s Pharmaceutical Benefits Scheme with listing anticipated on 1 December 2025.

Aflibercept is currently the subject of patent infringement proceedings in Australia. On 8 September 2025, the Federal Court of Australia published a judgment refusing to award Regeneron and Bayer an interlocutory injunction against Sandoz to prevent the launch of Sandoz’s Afqlir®. Regeneron/Bayer filed an application for leave to appeal that decision on 17 September 2025. Regeneron/Bayer are separately seeking preliminary discovery from Sandoz in relation to a second Regeneron aflibercept patent, AU2020397865, which is scheduled for hearing on 6 November 2025.

Actor Pharmaceuticals, which does not yet have an aflibercept biosimilar approved in Australia, filed revocation proceedings against Regeneron and Bayer in the Australian Federal Court on 5 August 2025, seeking to invalidate AU2012205599, with a first case management hearing in that matter currently scheduled for 8 October 2025.

FDA Approves Biocon’s Denosumab Biosimilars Bosaya™ and Aukelso™

Sep 17, 2025

On 17 September 2025, Biocon Biologics announced that it received FDA approval for denosumab products Bosaya™ and Aukelso™, biosimilars to Amgen’s Prolia® and Xgeva®, respectively. The FDA granted provisional interchangeability designation for Bosaya™ and Aukelso™ for all approved indications.

Biocon’s denosumab biosimilars are the sixth pair to be approved in the US, following 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), and Shanghai Henlius/Organon’s Bildyos® and Bilprevda® (approved September 2025, not yet launched).

In June 2025, Amgen sued Henlius and Organon in the US in relation to their denosumab biosimilars, alleging infringement of 26 US patents covering denosumab, pharmaceutical compositions of denosumab, methods of manufacturing therapeutic proteins, like denosumab, and denosumab products. Amgen also has pending BPCIA denosumab litigation against Hikma/Gedeon Richter and Biocon. On 16 July 2025, BPCIA litigation involving Accord/Intas and Amgen concluded following a settlement between the parties permitting Accord/Intas to launch its denosumab biosimilars in the US after 1 October 2025.

Formycon/Klinge’s Biosimilar Aflibercept to be Commercialised by Horus Pharma in EU

Sep 17, 2025

On 17 September 2025, Formycon announced that Klinge Biopharma, the exclusive holder of the global commercialisation rights for Formycon’s FYB203, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), has entered a semi-exclusive licence agreement with French ophthalmology laboratory, Horus Pharma, for the commercialisation of FYB203 (under the brand name Baiama®) in selected European countries.

Under the agreement, Klinge will receive upfront and milestone payments, plus royalties on net sales. Formycon will participate in all payment streams to Klinge, in the mid-single digit to low-double digit percentage range, and will receive additional payments for organising the commercial market supply chain on behalf of Klinge.

FYB203 (aflibercept) received European marketing approval in January 2025 as Baiama® and Ahzantive®. Neither Baiama®/Ahzantive®, nor any of the ten other EU approved aflibercept biosimilars, has been launched in Europe to date.

The agreement between Klinge and Horus follows an earlier semi-exclusive commercialisation agreement between Klinge and Teva Pharmaceuticals for FYB203 covering major parts of Europe (excluding Italy) and Israel, entered in mid-January 2025. Teva will market the product under the Ahzantive® brand name.

Alteogen’s Biosimilar Aflibercept EU Approved

Sep 17, 2025

On 17 September 2025, Alteogen announced that the European Commission has approved Eyluxvi® (ALT-L9), biosimilar to Regeneron/Bayer’s Eylea® (aflibercept). According to Alteogen, Eyluxvi® is the first biosimilar developed by Alteogen through independent in-house research and global clinical development with its subsidiary, Alteogen Biologics.

Eyluxvi® received a positive CHMP opinion in July 2025 for the treatment of nAMD, macular oedema secondary to retinal vein occlusion, diabetic macular oedema and myopic choroidal neovascularisation. Alteogen submitted its MAA in July 2024.

There are 9 other aflibercept biosimilars approved in Europe: Biocon’s Yesafili® (September 2023), Sandoz’s Afqlir® (November 2024), Samsung Bioepis/Biogen’s Opuviz™ (SB15) (November 2024), Formycon/Klinge’s Baiama® and Ahzantive® (January 2025), Celltrion’s Eydenzelt® (February 2025), Amgen’s Pavblu® (April 2025), Alvotech/Advanz’s Mynzepli® (August 2025). Sam Chun Dang announced on 20 August 2025 that its aflibercept biosimilar received EU marketing authorisation, although the name of the product is not yet known.

Alvotech Files US PGR Challenging Regeneron’s Method of Treatment Patent for High Dose Aflibercept

Sep 17, 2025

On 17 September 2025, Alvotech filed a petition for post grant review of Regeneron’s patent US12168036 entitled “Methods for Treating Angiogenic Eye Disorders with High Doses of VEGF Receptor Fusion Proteins”. The patent was granted on 17 December 2024 and relates to methods for treating an angiogenic eye disorder by intravitreal administration of about 100 microlitres or less of at least about 8mg of a VEGF receptor fusion protein in a formulation with a particular viscosity.

Alvotech’s petition argues that the claims of the patent are invalid for lack of novelty, obviousness, and lack of written description.

Regeneron’s Eylea HD® (aflibercept, 8mg) is approved for nAMD, DME and diabetic retinopathy in the US (August 2023). Regeneron has filed regulatory submissions with the FDA for Eylea HD® in relation to the treatment of macular oedema following retinal vein occlusion (RVO) and an extension of the dosing schedule to include every 4-week dosing across approved indications and an Eylea HD® pre-filled syringe. The FDA’s target action date is Q4/2025.

Eylea HD® (known as Eylea™ 8mg in Europe) was jointly developed by Bayer and Regeneron. Regeneron holds the exclusive rights to both 2mg and 8mg Eylea® in the US, while Bayer holds those outside the US, where the companies equally share the profits from sales of the products.

Eylea® 8mg for intravitreal injection is approved for nAMD and DME including in the EU (January 2024), Japan (January 2024), UK (January 2024) and Australia (June 2024). Eylea® 8mg pre-filled syringe (OcuClick) was approved in Europe (September 2024), Australia (October 2024) and Korea (August 2025). In addition to the US application, Regeneron/Bayer have submitted marketing authorisation applications for Eylea® 8mg for the treatment of patients with macular oedema following RVO in Japan (May 2025) and Europe (April 2025).

Alvotech is developing AVT29, a biosimilar to Regeneron’s Eylea® 8mg. Teva holds commercialisation rights for AVT29 (and AVT06, aflibercept 2mg) in the US. In June 2024, Alvotech entered into an agreement with Advanz Pharma in relation to the commercialisation of AVT29 (and AVT06) in Europe.

Regeneron/Bayer Appeal Australian Court’s Refusal to Grant PI and Prevent Launch of Sandoz’s Biosimilar Aflibercept

Sep 17, 2025

On 17 September 2025, Regeneron filed an application for leave to appeal the decision of Justice Rofe of the Federal Court of Australia refusing to award Regeneron/Bayer a preliminary injunction against Sandoz to prevent the launch of Sandoz’s Afqlir®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept). The hearing is scheduled for 29 October 2025 before Justices Beach, Burley and Moshinsky.

Regeneron/Bayer commenced the proceedings against Sandoz on 4 June 2025 alleging infringement of Regeneron’s patent no. AU2012205599 relating to methods of treatment for angiogenic eye disorders. Regeneron/Bayer sought both an interlocutory injunction and final relief, and Sandoz cross-claimed for invalidity of the patent. On 3 September 2025, the Federal Court of Australia refused to award Regeneron/Bayer an interlocutory injunction preventing Sandoz from launching its aflibercept biosimilar in Australia.

There is no automatic right to appeal from an interlocutory decision of the Federal Court of Australia and Regeneron/Bayer must obtain leave before the Full Court will hear the appeal. Often the leave application and, if leave is granted, the substantive appeal, are heard at the same time.

Sandoz’s aflibercept biosimilars, Afqlir® and Enzeevu®, were approved by the TGA on 27 May 2025 and were the first aflibercept biosimilars to be considered (and now recommended) for reimbursement, with PBS listing to commence from 1 December 2025. Sandoz indicated during the court proceeding that it does not intend to launch Enzeevu® in 2025.

Actor Pharmaceuticals, which does not yet have any aflibercept biosimilar approved in Australia, filed legal proceedings against Regeneron and Bayer in the Australian Federal Court on 5 August 2025, seeking to invalidate AU2012205599, with a first case management hearing in that matter currently scheduled for 8 October 2025.

Regeneron/Bayer are separately seeking preliminary discovery from Sandoz regarding a further Regeneron aflibercept patent, AU2020397865. That matter is scheduled for hearing on 6 November 2025.

Mitsubishi Tanabe’s Co-Promotion of Janssen’s Stelara® to End on 31 December 2025 in Japan

Sep 16, 2025

Under the co-promotion agreement, MTPC has been responsible for distribution of Stelara® in Japan, with both MTPC and Janssen jointly conducting promotion of Stelara® to healthcare professionals. After 31 December 2025, Janssen will exclusively handle the sales, distribution, and information provision activities for Stelara® in Japan, with MTPC continuing the distribution of Stelara® bearing the MTPC name until the inventory is depleted.

This news follows a series of recent announcements by biosimilar competitors relating to the launch of ustekinumab in Japan, including:

Celltrion’s launch of Steqeyma® (CT-P43), biosimilar to Stelara®, in Japan on 8 July 2025.
Samsung Bioepis’ partnership agreement with NIPRO Corporation in Japan for multiple biosimilars, including SB17, Samsung Bioepis’ biosimilar to Stelara®.
Biocon Biologics’ May 2025 announcement that Yoshindo, its commercial partner, launched Ustekinumab BS Subcutaneous Injection in Japan for treatment of psoriasis vulgaris and psoriatic arthritis.

Pearce IP BioBlast® for the fortnight ending 12 September 2025

Sep 16, 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the fortnight ending 12 September 2025 are set out below:

Aflibercept

10 September 2025 | UK | Regeneron Files UK Patent Proceedings Against Alvotech and Fisher Clinical Services for Aflibercept Biosimilar

On 10 September 2025, Regeneron filed a patent infringement suit against Alvotech and Fisher Clinical Services UK Limited in the High Court of Justice for England & Wales… Read more here.

9 September 2025 | US | Sandoz’s Biosimilar Aflibercept US Launch Set for Q4 2026 Following Regeneron Settlement

On 9 September 2025, Sandoz announced that it has settled all US patent disputes with Regeneron relating to Sandoz’s Enzeevu®, biosimilar to Regeneron’s Eylea® (aflibercept)… Read more here.

8 September 2025 | AU | Regeneron Aflibercept PI Refused Against Sandoz, AU Market Open to Biosimilars

On 8 September 2025, Justice Rofe of the Federal Court of Australia published a judgment refusing to award Regeneron and Bayer a preliminary injunction against Sandoz to prevent the launch of Sandoz’s Afqlir®, biosimilar to Regeneron/Bayer’s Eylea® … Read more here.

Certolizumab Pegol

1 September 2025 | IN | India’s CDSCO Approves Lupin’s Ph 1 Trial for Biosimilar Peg Certolizumab

On 1 September 2025, Medical Dialogues reported that Lupin received approval from India’s Central Drugs Standard Control Organisation (CDSCO) to conduct a Phase 1 study of its certolizumab pegol biosimilar in 200mg PFS presentation… Read more here.

Daratumumab

1 September 2025 | EU | EU Approves Ph 3 Trial for Celltrion’s Daratumumab Biosimilar

On 1 September 2025, Korea Biomedical Review reported that the European Medicines Agency (EMA) has approved Celltrion’s Phase 3 clinical trial plan (IND) for CT-P44, biosimilar to Johnson & Johnson’s Darzalex® … Read more here.

Denosumab

2 September 2025 | US | FDA Approves Shanghai Henlius/Organon’s Denosumab Biosimilars

On 2 September 2025, Shanghai Henlius and Organon announced that the FDA has approved Bildyos® and Bilprevda® (HLX14), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) respectively, … Read more here.

1 September 2025 | PK | Mabwell/Searl’s Denosumab Biosimilar Approved in Pakistan

On 1 September 2025, Searl announced that it has gained approval from Pakistan’s Drug Regulatory Authority to market and sell its denosumab biosimilars, referencing Amgen’s Prolia® and Xgeva®… Read more here.

Guselkumab, Ocrelizumab, Vedolizumab

2 September 2025 | MENA | Polpharma Inks Licensing Deal with MS Pharma for Guselkumab, Ocrelizumab and Vedolizumab Biosimilars

On 2 September 2025, Polpharma Biologics S.A. and MS Pharma announced that they have entered into licensing agreements for the commercialisation of proposed biosimilar candidates to guselkumab… Read more here.

Nivolumab

4 September 2025 | BR | Counterfeit Opdivo® (Nivolumab) Seized in Brazil

On 4 September 2025, Brazil’s National Health Surveillance Agency (Anvisa) announced that it seized a batch of a drug sold under the name Opdivo®… Read more here.

Omalizumab

11 September 2025 | LATAM | Kashiv BioSciences Partners with CRISTÁLIA on Omalizumab Biosimilar in Latin America

On 11 September 2025, Kashiv BioSciences announced that it has entered into a licensing and supply agreement with Brazilian pharmaceutical company, CRISTÁLIA… Read more here.

10 September 2025 | EU | Celltrion Set for 2025 EU Launch of Biosimilar Omalizumab

On 10 September 2025, Celltrion confirmed that it is planning the European launch of Omlyclo® (CT-P39)… Read more here.

Omalizumab, Ustekinumab

4 September 2025 | AU | Celltrion/Arrotex’s Ustekinumab and Omalizumab Biosimilars Launched in Australia

On 4 September 2025, Celltrion announced that it has launched Steqeyma® (ustekinumab) and Omlyclo® (omalizumab) in Australia… Read more here.

Pembrolizumab

5 September 2025 | Pembrolizumab Included on WHO Essential Medicines List

On 5 September 2025, the World Health Organisation (WHO) announced that it has updated its Model List of Essential Medicines (EML) to include pembrolizumab… Read more here.

Secukinumab

10 September 2025 | Celltrion Ph 1 Results for Secukinumab Biosimilar

On 10 September 2025, Celltrion announced that it will present its global Phase 1 clinical trial results for CT-P55… Read more here.

Biopharma Deals

1 September 2025 | CapVest to Acquire Majority Stake in STADA

On 1 September 2025, STADA announced that international private equity investment firm, CapVest Partners LLP, has signed a definitive agreement to acquire the majority stake … Read more here.