Other Updates

On 8 January 2026, Takeda announced that it has entered a global collaboration and licence agreement with Halozyme Therapeutics, Inc, which grants Takeda exclusive rights to Halozyme’s Enhanze® drug delivery technology for use with Takeda’s Entyvio® (vedolizumab).

Under the agreement, Takeda will make an upfront payment and potential future development and commercial milestone payments to Halozyme.  Halozyme will also receive royalties on sales of products containing vedolizumab in combination with Enhanze®.

Entyvio® is approved including in the US and EU for adults with ulcerative colitis and moderately to severely active Crohn’s disease in both IV and subcutaneous formulations.

There are a number of vedolizumab biosimilars in development.  In September 2024, Alvotech commenced a Phase 3 clinical trial for its vedolizumab biosimilar, AVT16, in moderate to severe ulcerative colitis.  Alvotech’s AVT16 is subject to a 2023 licence agreement with Advanz, under which Advanz will commercialise the biosimilar in Europe, the UK and Switzerland.

In February 2025, Intas Pharmaceuticals received approval from India’s Central Drug Standard Control Organisation (CDSCO) to conduct a Phase I bioequivalence study of its biosimilar vedolizumab, INTP53 (powder for concentrate for solution for infusion (300mg/vial)).  In August 2025 and September 2025 respectively, Polpharma Biologics entered into a global licensing agreement (excluding the MENA region) with Fresenius Kabi for the commercialisation of PB016 (vedolizumab) and a licence agreement with MS Pharma for commercialisation in the MENA region of a number of biosimilars, including PB016.

On 8 January 2026, the Munich Regional Court granted Regeneron and Bayer preliminary injunctions (PIs) preventing STADA, Hexal, Celltrion and Advanz Pharma from marketing their aflibercept biosimilars in Germany and requiring them to recall any products already on the market.  According to a Juve Patent report, while the PI against STADA, Hexal and Celltrion is limited to Germany, the PI against Advanz covers 21 countries.

The Court’s rulings are based on Regeneron’s patent, EP 2 364 691, relating to a formulation of aflibercept, the active ingredient of Regeneron/Bayer’s Eylea®.

The biosimilars restrained by the PIs granted by the Court are as follows:

• Afqlir®, a product of the Sandoz Group, of which Hexal is a part in Germany. Afqlir® was EU-approved in November 2024 and was launched in the UK in November 2025.  At the time of the UK launch, Sandoz announced that launches in major European markets such as Germany and France would follow, with additional European rollouts to occur in 2026;
• Celltrion’s Eydenzelt® (CT-P42), which received European approval in February 2025;
• Advanz’s Mynzepli®, which was approved in Europe in August 2025. Mynzepli® (AVT06) was developed by Alvotech and, under a June 2024 agreement, Advanz has the exclusive commercialisation rights to the product throughout Europe, except in Germany and France, where the rights are semi-exclusive; and
• STADA’s Afiveg®, which was EU approved in September 2025.

Celltrion has subsequently announced that it is “actively pursuing patent agreements” with Regeneron/Bayer in relation to aflibercept, including in Germany, in order to “quickly introduce the product to the market”.

The successful PI applications by Regeneron/Bayer in Germany follow a PI granted by the same German court in September 2025, with a permanent cross-border injunction granted in October 2025, preventing Formycon from launching its aflibercept biosimilar, FBY203 (Baiama®/Ahzantive®), in multiple European countries.  Formycon has lodged an appeal.

In November 2025, Alvotech succeeded in defending Regeneron/Bayer’s request for an injunction from the UK High Court to prevent UK manufacturing activities under the SPC waiver notice provisions in relation to Mynzepli® (AVT06) (aflibercept).  This ruling cleared the way for pre SPC expiry UK manufacturing activities to progress enabling the “day 1” (post SPC expiry) launch of AVT06 in the UK, Europe and other countries following the expiry of Regeneron’s SPC on European patent EP 1 183 353 (encompassing aflibercept) on 23 November 2025.

GSK’s Nucala® (mepolizumab) has received approval in China and the UK as an add-on maintenance treatment for adult patients with inadequately controlled COPD characterised by raised blood eosinophils.

The approval by China’s National Medical Products Administration (NMPA) was announced by GSK on 5 January 2026 and followed submission of an application for the expanded indication in February 2024.  Nucala® was previously approved in China for a number of indications, including as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) (January 2025), and as add-on maintenance treatment for severe eosinophilic asthma in adults and adolescents aged 12 years and older (January 2024).

On 7 January 2026, PMLive reported that Nucala® also received approval for the same indication from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).  The COPD indication was recommended by the European Medicines Agency’s CHMP in December 2025, nine months after its submission to the EMA in March 2025.

Nucala® is approved for COPD in the United States (May 2025).  The COPD indication extension remains under review by Australia’s TGA (June 2025).

Bio-Thera is currently developing a mepolizumab biosimilar, BAT2606, which has completed Phase 1 trials (according to the company’s pipeline), and is the subject of an exclusive commercialisation deal struck in March 2024 with Costa Rican healthcare product distributor SteinCares for the marketing rights of the drug across Latin America.

On 6 January 2026, Fresenius Kabi announced that it has introduced a new presentation of Otulfi®, biosimilar to Janssen’s/J&J’s Stelara® (ustekinumab), in a 45 mg/0.5 mL single-dose vial for subcutaneous injection.

Following the introduction of this new presentation, Fresenius Kabi now offers all dosage forms and strengths of Stelara®, with Fresenius Kabi’s Otulfi® also having received interchangeability designation from the FDA in May 2025.

Otulfi® was developed by Formycon and was approved in the US and Europe in September 2024.  It is being commercialised in the US, Canada and most of Europe by Fresenius Kabi, under a global licence agreement entered into between Formycon and Fresenius in February 2023.  In August 2023, Formycon and Fresenius reached a settlement with J&J in the US enabling the US launch of Otulfi® in March 2025.

There are a number of other 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), Celltrion’s Steqeyma® (March 2025) and Hikma’s Starjemza™ (November 2025).

On 6 January 2026, Biocon Biologics announced that it will unveil three new biosimilars at the 2026 J.P. Morgan Healthcare Conference to be held 12-16 January 2026 in San Francisco.  The as yet unnamed biosimilars are for pembrolizumab (referencing MSD’s Keytruda®), nivolumab (referencing BMS’ Opdivo®) and trastuzumab/hyaluronidase (referencing Roche’s Herceptin® SC, marketed in the US as Herceptin Hylecta™).  The stage of development of each of the biosimilars is not yet known.

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®.  In December 2025, Formycon announced agreements with MS Pharma for the commercialisation of pembrolizumab biosimilar FYB206 in the MENA region and with Zydus Lifesciences for the US and Canada.

There are a number of nivolumab biosimilars already undergoing clinical trials, including Sandoz’s JPB898 (phase I), Amgen’s ABP 206 (phase III), Xbrane/Intas’ Xdivane™ (phase I/III), Boan Biotech’s BA1104 (phase III), and Reliance Life Sciences’ R-TPR-067 (phase I/III).  In December 2025, Shanghai Henlius announced that the FDA approved an IND for a phase I trial of HLX18 (nivolumab).

Celltrion announced in December 2025 that it has been conducting clinical trials for Herzuma® SC (CT-P6 SC), biosimilar to Roche’s Herceptin® SC/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.

On 2 January 2026, Samsung Bioepis announced that it has begun direct commercialisation of Byooviz®, biosimilar to Genentech’s Lucentis® (ranibizumab), in Europe, following the transfer back of commercial rights from Biogen to Samsung Bioepis.

The pre-filled syringe (PFS) presentation of Byooviz® is expected to become available in Europe from Q2 2026, following a positive opinion of the EMA’s CHMP for Byooviz® pre-filled syringe (PFS) in December 2025.

Samsung Bioepis and Biogen had partnered in November 2019 in relation to commercialisation of two ophthalmology biosimilars (Byooviz® and Opuviz™ (biosimilar to Regeneron/Bayer’s Eylea® (aflibercept)) 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.  In October 2025, Samsung Bioepis announced that it had entered into an Asset Purchase Agreement with Biogen in Europe for the two ophthalmology biosimilars.

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).

On 1 January 2026, Medical Dialogues reported that Dr Reddy’s has disclosed to various stock exchanges that it has received a Complete Response Letter (CRL) from the FDA in relation to its Biologics Licence Application (BLA) for AVT03, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab).

Dr Reddy’s and Alvotech entered into a licence and supply agreement in May 2024 for the commercialisation of AVT03, under which Alvotech develops and manufactures the product and Dr Reddy’s will commercialise it exclusively in the US, and semi-exclusively in the EU and UK.

The CRL follows a pre-licence inspection of Alvotech’s Reykjavik manufacturing facility.  The CRL did not identify any other deficiencies with the BLA.  Inspection of the same facility also resulted in a CRL issued in November 2025 for Alvotech’s BLA for AVT05, biosimilar to J&J’s Simponi® (golimumab).

Alvotech/Dr Reddy’s BLA for AVT03 was accepted for review by the FDA in March 2025.  In November 2025, Amgen filed BPCIA litigation in the US District Court for the District of New Jersey against Dr Reddy’s/Alvotech alleging infringement of 31 US patents covering denosumab, pharmaceutical compositions of denosumab, methods of manufacturing therapeutic proteins like denosumab, and denosumab products.

AVT03 was approved in Europe in November 2025.  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®).

On 31 December 2025, Outlook Therapeutics announced that the FDA issued a Complete Response Letter (CRL) regarding the second resubmission of its Biologics Licence Application (BLA) for its ophthalmic formulation of bevacizumab, ONS-5010/Lytenava™, for wet AMD.

The CRL comes 7 weeks after the FDA accepted Outlook’s second resubmission of its BLA for Lytenava™ in November 2025.  In the CRL, the FDA indicated that the mechanistic and natural history data added in the BLA resubmission did not alter its earlier assessment.  While the FDA acknowledged that the single adequate and well-controlled study demonstrated efficacy, it again recommended that additional confirmatory evidence be provided to support the application, though did not clarify what type of evidence would be acceptable.

Bob Jahr, CEO of Outlook Therapeutics, stated that while Outlook is “disappointed and disagree[s] with this decision”, they are “fully committed to taking all necessary steps to receive approval in the United States”.

Outlook Therapeutics received a first CRL from the FDA for Lytenava™ in August 2023 and subsequently submitted a Special Protocol Assessment request in December 2023 regarding further clinical trials.  It resubmitted its BLA to the FDA in February 2025 based on positive results of the NORSE EIGHT clinical trial, announced in January 2025.  A second CRL (issued in August 2025) recommended that Outlook submit additional efficacy data to support its application for Lytenava™.  Outlook resubmitted its BLA to the FDA for a second time in early November 2025.

Lytenava™ was approved in the EU in May 2024 and was launched in the UK and Germany for wet AMD in June 2025.  The Scottish Medicines Consortium accepted Lytenava™ for use within NHS Scotland in June 2025.

Intas Pharmaceuticals reportedly has an ophthalmic bevacizumab biosimilar under development, having received approval from India’s CDSCO in March 2025 to conduct Phase 2/3 trials of bevacizumab (solution for intravitreal injection 25mg/mL) in patients with wet AMD.

On 31 December 2025, Mabwell announced that it has received marketing approval from the Indonesian Food and Drug Authority for its Adalimumab Injection 9MW0113, biosimilar to AbbVie’s Humira®.

Mabwell jointly developed the biosimilar with Shanghai Junshi Biosciences and it was approved in China in March 2022, where it is marketed as Junmaikang®.  Mabwell reports that it has signed formal cooperation agreements for 9MW0113 in more than ten countries and has submitted registration applications in multiple countries, including Jordan and Peru.

Mabwell’s biosimilar portfolio also includes Mailishu® and Maiweijian™, referencing Amgen’s Prolia® and Xgeva® (denosumab), which were approved in China in March 2023 and April 2024, respectively, and first launched outside of China in December 2025.  According to Mabwell, it has submitted marketing authorisation applications for its denosumab biosimilars in several other key markets, including Jordan, Egypt, and Brazil.

On 27 December 2025, Medical Dialogues reported that Aurobindo Pharma’s wholly-owned subsidiary, CuraTeQ, had terminated its agreement with US-based BioFactura Inc regarding BFI-751, biosimilar to Janssen’s/J&J’s Stelara® (ustekinumab).  The termination is said to have been by consent and to have followed a strategic review of CuraTeQ’s portfolio prioritisation efforts.

Under the agreement before its termination, CuraTeQ had global manufacturing rights and an exclusive licence to commercialise BFI-751, in all major ‘regulated’ markets including the US, EU, UK, Canada, ANZ.

CuraTeQ remains actively involved in the development of biosimilars, announcing positive results from its Phase 3 trial of BP16, biosimilar to Amgen’s Prolia® (denosumab) in September 2025.  According to that announcement, CuraTeQ plans to begin regulatory submissions for BP16 in the EU, US, and other key regions from January 2026.  Earlier in July 2025, The Economic Times reported that CuraTeq had received marketing approval from the European Commission for Dazublys®, biosimilar to Roche/Genentech’s Herceptin® (trastuzumab).