Other Updates

On 27 June 2025, Bayer announced that the European Commission has granted a label extension for Eylea™ 8mg (aflibercept, 114.3mg/ml solution for injection) with extended treatment intervals of up to 6 months for the treatment of nAMD and visual impairment due to diabetic macular oedema (DME).

This news comes just over a month after the label extension was recommended by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in May 2025.

Eylea™ 8mg (known as Eylea HD® in the US) 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™ 8 mg (aflibercept 8 mg) has been approved to date in more than 60 markets for the treatment of nAMD and DME.  Regeneron/Bayer have recently submitted marketing authorisation applications for Eylea™ 8mg for the treatment of patients with macular oedema following retinal vein occlusion (RVO) in Japan (May 2025), Europe (April 2025) and the US (application accepted by FDA for priority review in April 2025, with a target action date of 19 August 2025).

On 27 June 2025, Biocon Biologics announced that Yesafili™, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2mg) has been approved by Health Canada in vial and PFS presentations, becoming the first aflibercept biosimilar approved in Canada.  It is indicated for nAMD, visual impairment due to macular oedema secondary to RVO, diabetic macular oedema (DME) and myopic CNV.

The Canadian launch of Yesafili™ is planned for 4 July 2025, as a result of a March 2024 settlement between Biocon and Regeneron/Bayer.  The July 2025 Canadian launch will be the first launch of Yesafili™ worldwide.  Amgen’s Pavblu™ (aflibercept) was launched in the US in October 2024.

Yesafili™ was the first aflibercept biosimilar approved in Europe in September 2023 (where it is not yet launched).  In the US, both Yesafili™ and Samsung Bioepis’ Opuviz®, were the first approved interchangeable aflibercept biosimilars in May 2024.  Biocon and Regeneron settled US BPCIA litigation regarding aflibercept in April 2025, paving the way for a US launch of Yesafili™ in the second half of 2026, or earlier under certain undisclosed circumstances.

On 26 June 2025, Formycon announced that it has entered into a non-exclusive distribution agreement with Teva Group’s subsidiary, Ratiopharm GmbH, to commercialise FYB202/Fymskina®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), in Germany.  German launch of Fymskina® is planned for Q3 2025.

Under the agreement, which follows the European Commission’s approval of Fymskina®/FYB202 in September 2024, Formycon is responsible for manufacture and supply, and Ratiopharm is responsible for commercialisation.

Formycon entered into a global commercialisation partnership for FYB202 with Fresenius Kabi in February 2023, in which Formycon retained secondary commercialisation rights for Germany, parts of Latin America, and the MENA region.  Pursuant to the global commercialisation agreement, Formycon and Fresenius Kabi launched FYB202 (marketed as Otulfi®) in Canada in May 2025 and in the US in March 2025 (securing US interchangeability for FYB202 in May 2025).  Formycon also separately entered into a licence/supply agreement with MS Pharma for countries in the MENA region in December 2024.

On 26 June 2025, New Zealand Doctor reported that Novo Nordisk is set to launch Wegovy® (semaglutide) in New Zealand from 1 July 2025.

New Zealand’s Medsafe approved Wegovy® in March 2025 for two indications:

• an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults and adolescents aged 12 years and above; and
• as an adjunct to standard of care therapy to reduce the risk of major adverse cardiovascular events (MACE) in adults with established cardiovascular disease (CVD) without established Type 1 or Type 2 diabetes.

Semaglutide was first approved in New Zealand as Ozempic® in March 2023, indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise.

Wegovy® was launched in Australia in August 2024, following its approval in September 2022 for weight management.  In December 2024, Australia’s Therapeutic Goods Administration (TGA) approved an indication extension for Wegovy® to reduce the risk of MACE in overweight and obese adults with established CVD and without established Type 1 or Type 2 diabetes.

On 25 June 2025, Amgen filed BPCIA litigation in the US District Court for the District of New Jersey against Hikma Pharmaceuticals/Gedeon Richter and Shanghai Henlius Biotech/Organon, asserting infringement of multiple US patents (32 for Hikma/Richter and 26 for Henlius/Organon) covering denosumab, pharmaceutical compositions of denosumab, methods of manufacturing therapeutic proteins, like denosumab, and denosumab products.

The litigation follows the FDA’s acceptance in December 2024 of Richter/Hikma’s BLA for RGB-14-P and RGB-14-X, biosimilars to Amgen’s Prolia® and Xgeva® (denosumab).  Under an exclusive licence agreement entered in December 2021, Gedeon Richter is responsible for the development of RGB-14, while Hikma is responsible for FDA registration and has exclusive rights to commercialise it in the US following approval.

Organon and Shanghai Helius’ BLA for HLX14 (denosumab) was accepted for review by the FDA in October 2024.  In June 2022, Shanghai Henlius entered into a licence agreement with Organon regarding HLX14 (and pertuzumab, HLX11) under which Organon has exclusive global commercialisation rights for all countries except China, Hong Kong, Macau and Taiwan.

The complaints against Hikma/Richter and Henlius/Organon represent the 6^th and 7^th BPCIA suits filed by Amgen in the US in relation to alleged patent infringement concerning denosumab biosimilars.  However, Amgen has settled three of its US denosumab disputes over the last 18 months.  A dispute with Sandoz, commenced in May 2023, was resolved in April 2024, enabling Sandoz to launch its denosumab biosimilars, Jubbonti® and Wyost®, in the US from 31 May 2025.  Amgen settled its US litigation against Celltrion in January 2025, permitting US launch of Celltrion’s denosumab biosimilar, CT-P41, from 1 June 2025.  In March 2025, Amgen entered into a global settlement of its patent infringement litigation in relation to Fresenius Kabi’s denosumab biosimilar, allowing US launch of Fresenius’ biosimilar in mid-2025.  Amgen’s BPCIA litigation against Accord/Intas and Samsung Bioepis regarding their denosumab biosimilars remains pending.

On 25 June 2025, Bio-Thera Solutions, Ltd. and Costa Rican-based SteinCares announced that they have signed an agreement to commercialise biosimilar dupilumab across Latin America.  Under the agreement, Bio-Thera will be responsible for product development and supply, while SteinCares will lead the registration and commercialisation process throughout Latin America.

Bio-Thera’s BAT2406, biosimilar to Sanofi’s Dupixent® (dupilumab), is currently undergoing Phase I clinical trials.

This is the fourth product on which the companies have agreed to collaborate in the region.  An agreement was announced in March 2024 in relation to BAT2606, biosimilar to GSK’s Nucala® (mepolizumab) and BAT2506, biosimilar to J&J’s Simponi® and Simponi Aria® (golimumab).  The partnership was expanded in December 2024 to include a third undisclosed product.

On 25 June 2025, Formycon announced that Klinge Biopharma, its exclusive global licensee of FYB203/Ahzantive®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2 mg), has entered an exclusive licence agreement with Valorum Biologics for commercialisation of FYB203 in the US and Canada.

Under the agreement, Klinge will receive royalties on net sales and is eligible to receive upfront and milestone payments, with Formycon receiving a single to low double-digit percentage of those payment streams.  Formycon will additionally receive service payments and a volume-based profit component for organising the commercial market supply on behalf of Klinge.

FYB203 was approved in the US in June 2024, where it is currently subject to a preliminary injunction granted in June 2024, and upheld at the end of January 2025, resulting from a patent infringement proceeding brought by Regeneron in November 2023.

The only aflibercept biosimilar to have launched in the US is Amgen’s Pavblu™, which launched in October 2024 following the US Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for an injunction in relation to the biosimilar.  Regeneron has since commenced new BPCIA litigation against Amgen for Pavblu™ (June 2025), which is pending.

Formycon developed FYB203 and Klinge holds the exclusive global commercialisation rights.  In mid-January 2025, Formycon/Klinge and Teva Pharmaceuticals entered a collaboration agreement for the semi-exclusive commercialisation of FYB203 in Europe (excluding Italy) and Israel.  FYB203 received approval from the European Medicines Agency (EMA) in January 2025, under the brand names Ahzantive® and Baiama®, and from the UK Medicines and Healthcare products Regulatory Agency (MHRA) in February 2025.

In May 2024, Valorum partnered with Xbrane and STADA in relation to their ranibizumab biosimilar, which has not yet been approved in the US.

On 24 June 2025, Biocon Biologics announced it has partnered with the National Cancer Society of Malaysia (NCSM), a non-for-profit organisation, to launch a Patient Assistance Program advocating for the accessibility and affordability of biosimilars.  Biocon intends to supply the NCSM with a range of biosimilars from its oncology portfolio, including trastuzumab, pegfilgrastim and bevacizumab.  The program will commence with provision of bTrastuzumab to cancer patients currently facing treatment delays due to budget constraints.

In the US, Biocon’s oncology franchise includes Ogivri® (biosimilar trastuzumab, launched in December 2019), Fulphila® (biosimilar pegfilgrastim, approved June 2018) and Jobevne™ (biosimilar bevacizumab, approved April 2025).

On 24 June 2025, Ono Pharmaceutical and BMS announced that they have received a supplemental approval for expanded use of Ono’s Opdivo® (nivolumab) and BMS’ Yervoy® (ipilimumab) in combination for the treatment of unresectable hepatocellular carcinoma (HCC).  The approval comes almost a year after the companies submitted the supplemental application in August 2024.

The combination therapy has previously been approved for HCC in the US (April 2025) and EU (March 2025) and remains under consideration in Australia.  In May 2025, Australia’s Therapeutic Goods Administration (TGA) approved the combination therapy for unresectable or metastatic colorectal cancer (CRC), and it was recommended for PBS-listing for stage III melanoma in June 2025.

On 23 June 2025, Alvotech and Advanz Pharma announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for AVT06, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2mg).

AVT06 is indicated for the treatment of adults with nAMD, visual impairment due to macular oedema secondary to retinal vein occlusion, visual impairment due to diabetic macular oedema (DME) and visual impairment due to myopic choroidal neovascularisation (myopic CNV).

Alvotech and Advanz Pharma entered into an agreement in relation to the European commercialisation of AVT06 in June 2024.  Under the agreement, Advanz Pharma has exclusive commercialisation rights throughout Europe, except in Germany and France, where the rights are semi-exclusive.  The agreement also covers Alvotech’s AVT29, biosimilar to high-dose (8mg) Eylea®.

There are currently seven aflibercept (2mg) biosimilars approved in Europe: Celltrion’s Eydenzelt® (February 2025), 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) and Amgen’s Pavblu® (April 2025).

Amgen’s Skojoy® received a positive recommendation for marketing approval from the CHMP in January 2025 but the application was withdrawn in April 2025.  A number of aflibercept (2mg) biosimilars are also awaiting European Commission approval, including STADA’s Afiveg®, Polpharma’s Eiyzey® and Vgenfli®, and Advanz Pharma’s Mynzepli® (positive CHMP opinions adopted in June 2025).

In February 2025, Alvotech’s AVT06 BLA was accepted in the US, where it is to be commercialised by Teva.  Alvotech and Teva are expecting that regulatory approval from the FDA will be obtained in Q4 2025.