Other Updates

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 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.

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).

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).

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).

On 28 November 2025, Australia’s TGA updated its online list of prescription medicines for evaluation for the months of September, October and November.  Among the new inclusions is an indication extension for MSD’s Keytruda® (pembrolizumab) in combination with paclitaxel and/or bevacizumab to help treat certain types of ovarian, fallopian tube, or peritoneal cancer for people whose cancer has not responded to platinum-based medicines and who have already tried one or two other treatments.

This follows another indication extension application for Keytruda® accepted by the TGA in March 2025 for patients with head and neck squamous cell carcinoma (HNSCC) as a preliminary treatment prior to surgery or as a treatment in combination with radiotherapy followed by Keytruda® alone.  That application is still under consideration.

The HNSCC indication application was accepted by the US FDA in June 2025, and regulatory authorities in Brazil, Canada, Israel and Switzerland are also reviewing the application.

On 28 November 2025, Celltrion announced that Health Canada has approved its Eydenzelt®, biosimilar to Regeneron’s Eylea® (aflibercept), for all reference indications, in vial and pre-filled syringe forms.

Eydenzelt® is approved in a number of other regions, including in the US (October 2025), EU (February 2025) and Korea (May 2024).  In Australia, Eydenzelt® was approved solely for myopic CNV in March 2025, however, in July 2025, Celltrion filed an application with the TGA to expand Eydenzelt®’s indications to all those of Eylea®.  Eydenzelt® was considered for reimbursement at the November 2025 meeting of Australia’s Pharmaceutical Benefits Advisory Committee (PBAC), though the outcome has not yet been published.

The Canadian approval strengthens Celltrion’s position in North America following the settlement of US BPCIA litigation between Regeneron and Celltrion in relation to Eydenzelt® in October 2025, the terms of which permit Celltrion to launch Eydenzelt® in the US on 31 December 2026.

Launches of other US-approved aflibercept biosimilars have been delayed by BPCIA litigations brought by Regeneron.  However, the following proceedings have settled, with biosimilar launches scheduled for 2026:

• Biocon and Regeneron settled BPCIA litigation in April 2025, paving the way for a US launch of Yesafili™ in the second half of 2026 (or earlier under certain undisclosed circumstances); and
• Sandoz’s Enzeevu™ and Formycon’s Ahzantive® are set to launch in Q4/2026 (or earlier under certain undisclosed circumstances) after settlements were announced in September 2025 and October 2025, respectively.

A preliminary injunction was granted, and remains in place, preventing Samsung Bioepis’ US launch of biosimilar aflibercept (14 June 2024, upheld on appeal on 29 January 2025).

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 combination of pertuzumab and trastuzumab with the reference product, Roche’s Phesgo®.  Intas already has approval to market its biosimilar pertuzumab in India and, through its subsidiary Accord BioPharma, biosimilar trastuzumab in the USA.

There has been significant activity in relation to biosimilars to pertuzumab and trastuzumab as separate treatments.  Amgen has previously conducted trials on the combination.

Roche has recently indicated that biosimilar competition to Perjeta® (pertuzumab) is a bigger concern than it previously anticipated.  Roche is also taking legal action in India to prevent biosimilar competition to Perjeta® from Zydus’ Sigrima® product, with the High Court of Delhi issuing an interlocutory judgment in July 2025.

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

Two days earlier, on 25 November 2025, Celltrion also announced the completion of its Omlyclo® launch in major European countries including Germany, Spain, the UK and France, and that it has successfully secured bids from multiple hospital groups in the Netherlands, securing 70% of the Dutch market.

Omlyclo® is the first and only omalizumab biosimilar to be approved in the EU, with Celltrion’s 75 mg/0.5 mL and 150 mg/1 mL PFS formulations receiving EU market authorisation in May 2024.  Celltrion commenced its European rollout of Omlyco® with the launch of the product in Norway in September 2025.  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.

On 25 November 2025, Prestige Biopharma announced that it has entered into an exclusive license and supply agreement with Biosidus for the commercialisation of Tuznue®, biosimilar to Roche’s Herceptin® (trastuzumab), across a variety of Latin American markets including Argentina, Mexico, Bolivia and Paraguay.

Under the agreement, Biosidus will have exclusive rights to market and distribute Tuznue® in Argentina, Mexico, Bolivia, and Paraguay, while Prestige will be responsible for the production and supply through its EU-GMP-certified, high-tech facility equipped with advanced single-use technology. Biosidus will manufacture the drug product at its facility in Buenos Aires, Argentina, from which it will supply the product to the local market, and export the product to the markets of Mexico, Paraguay and Bolivia.

The agreement follows a separate licence agreement entered into by Prestige and Teva for the commercialisation of Tuznue® across a majority of European markets.  Under that agreement, Teva is responsible for marketing and distribution Tuznue® in a majority of European markets, while Prestige is responsible for production and supply, also through its EU-GMP-certified facilities.

Tuznue® was approved by the European Medicines Agency in September 2024, following the adoption of a positive opinion in July 2024, which landmarked the first major adoption of the product on the global stage.