On 22 December 2025, Alvotech announced the European launch of Gobivaz® (AVT05), biosimilar to Janssen’s Simponi® (golimumab), which is the first golimumab biosimilar to be marketed worldwide.

Gobivaz® has been awarded a National Health Service (NHS) England tender and, according to Alvotech, availability across EEA markets will “progress in line with national pricing and reimbursement processes”.

Gobivaz® was approved in Europe and the UK in November 2025 in both pre-filled syringe and autoinjector dosage forms (50 mg/0.5 mL and 100 mg/mL), with the European MAA for the product being the first golimumab biosimilar MAA to be accepted anywhere in the world in November 2024.

The biosimilar is being commercialised by Advanz in the UK and Europe under a May 2023 licence and supply agreement with Alvotech, which is responsible for development and commercial supply of the product.

AVT05 was the first golimumab biosimilar to be approved worldwide, with its September 2025 approval in Japan, where it is being commercialised by Fuji Pharma.   In the US, Alvotech/Teva’s Biologics License Application (BLA) for AVT05 was accepted by the FDA in January 2025.  The FDA issued a Complete Response Letter in relation to the BLA in early November 2025, with Alvotech working to resolve “certain deficiencies” identified following a manufacturing facility inspection.

A golimumab biosimilar, Gotenfia® (BAT2506), is also being developed by Bio-Thera.  Gotenfia® received a positive opinion from the EMA’s CHMP in early December 2025 and will be commercialised by STADA in Europe under a May 2024 agreement.

On 19 December 2025, Shanghai Henlius Biotech announced to investors that the US FDA has approved an investigational new drug application (IND) for the phase 1 clinical trial of HLX18, biosimilar to BMS’ Opdivo® (nivolumab), for the treatment of multiple solid tumours.  Henlius proposes to commence the clinical trial in the United States when the conditions are met.

Other nivolumab biosimilars already undergoing clinical trials include 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 August 2025, Sandoz voluntarily suspended its phase III trial of its nivolumab biosimilar, JPB898, as part of its decision to streamline its clinical trials following “ongoing encouraging and favourable regulatory developments” and feedback from major regulatory authorities regarding the requirements for biosimilar approvals.

Enzene Biosciences sought permission to conduct a phase III trial in India for its nivolumab biosimilar, but was requested to revise its proposed protocol.  Also in India, Zydus obtained approval of its ZRCr-4276 but has been prevented from launching due to legal action by BMS.

On 19 December 2025, Alvotech and Teva jointly announced that they have reached a settlement and licence agreement with Regeneron regarding the US launch of Alvotech’s AVT06, biosimilar to Regeneron’s Eylea® (aflibercept).  Under the agreement, Alvotech/Teva are permitted to launch AVT06 in Q4 of 2026, or earlier under certain undisclosed circumstances.

A Biologics Licence Application for AVT06 was accepted by the FDA for review in February 2025.  By way of a partnership commenced in August 2020, Teva holds the US commercialisation rights for AVT06.

Only a single biosimilar competitor to Regeneron’s Eylea® is currently on the market in the US; Amgen’s Pavblu®, launched October 2024.  However, there are a number of approved aflibercept biosimilars, some of which have scheduled 2026 launch dates as a result of litigation settlements: Biocon’s Yesafili® (approved May 2024, due to launch H2/2026), Formycon/Klinge’s Ahzantive® (approved June 2024, due to launch Q4/2026), Sandoz’s Enzeevu® (approved August 2024, due to launch Q4/2026) and Celltrion’s Eydenzelt® (approved October 2025, due to launch Q4/2026).  A preliminary injunction was granted, and remains in place, preventing Samsung Bioepis’ US launch of Opuviz® (14 June 2024, upheld on appeal on 29 January 2025).

AVT06 was approved in the EU and UK in August 2025, as Mynzepli®, and in Japan in September 2025.

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 AVT06.  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 1183353 (encompassing aflibercept) on 23 November 2025.

On 18 December 2025, Celltrion announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of an autoinjector (pre-filled pen) form of Steqeyma® and Qoyvolma®, biosimilars to J&J/Janssen’s Stelara® (ustekinumab).  The CHMP also recommended Qoyvolma® for a 45 mg vial formulation, such that Celltrion will have a “full lineup” of both products with all dosages and formulations of Stelara®.

According to Celltrion, the autoinjector device includes a viewing window and audible indicators to enable patients to easily identify the injection status and has “special thin-wall needle technology to help reduce injection pain”.

The positive EU opinion for the autoinjector presentation of Celltrion’s ustekinumab biosimilars, comes just days after Celltrion received approval for the same presentation of Steqeyma® in Australia.

Steqeyma® was first approved in the EU in September 2024 in a pre-filled syringe (45mg/0.5mL, 90mg/1mL) and vial (45mg/0.5mL) for subcutaneous injection, as well as 130mg/26mL concentrate for intravenous infusion.  It was launched in the EU in November 2024 and is indicated for adult and paediatric plaque psoriasis, active psoriatic arthritis and moderately to severely active Crohn’s disease.  Qoyvolma® received EU marketing approval in June 2025, with an additional indication to that of Steqyema®, being moderately to severely active ulcerative colitis in adults.

Ustekinumab biosimilars already being commercialised in Europe include STADA/Alvotech’s Uzpruvo® and Sandoz’s Pyzchiva®, both launched in July 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).

On 18 December 2025, the outcomes of Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) November 2025 meeting were published, including recommendations for the listing of three Celltrion biosimilars on the Pharmaceutical Benefits Scheme (PBS):

• Eydezenlt®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2mg);
• Stoboclo® and Osenvelt®, biosimilars to Amgen’s Prolia® and Xgeva® (denosumab); and
• Avtozma®, biosimilar to Roche’s Actemra® (tocilizumab).

Celltrion’s Eydenzelt® was the first aflibercept biosimilar TGA-approved on 31 March 2025 (solely for myopic CNV).  It was followed by Sandoz’s Afqlir® and Enzeevu® on 27 May 2025, and Samsung Bioepis’ Opuviz® on 18 September 2025, which were each approved for all reference indications.  Sandoz’s products were the first aflibercept biosimilars to be considered and recommended for listing on Australia’s Pharmaceutical Benefits Scheme, though have not yet been listed.

In December 2025, Regeneron/Bayer and Sandoz settled all Australian aflibercept patent infringement/revocation proceedings, with the terms of the settlement not otherwise being disclosed.  Regeneron/Bayer are defending pending revocation proceedings commenced by Actor Pharmaceuticals in August 2025 and have cross-claimed for infringement.

In addition to Celltrion’s Stoboclo® and Osenvelt® (approved April 2025), there are three other sponsors with denosumab biosimilars approved in Australia:  Sandoz’s Jubbonti® and Wyost® (August 2024), Samsung Bioepis’ Ospomyv® and Xborso® (July 2025) and Accord’s Denolia™/Deskeltia™ and Dostiva™/Dexeva™ (October 2025).  On 1 August 2025, Sandoz’s Jubbonti® and Wyost® became the first biosimilars to Amgen’s Prolia® and Xgeva® to be PBS-listed.  In April 2025, Amgen commenced Court proceedings in Australia seeking preliminary discovery of documents from Sandoz in relation to its denosumab biosimilars.  That proceeding concluded and Amgen commenced patent infringement litigation against Sandoz in the Federal Court of Australia in June 2025.

Celltrion’s Avtozma® is the first and only tocilizumab biosimilar to be approved in Australia (May 2025) and to be considered (and now recommended) for PBS-listing.

On 17 December 2025, Bristol Myers Squibb announced that Canada’s Drug Agency (CDA-AMC) has issued a positive reimbursement recommendation for Opdivo® (nivolumab) in combination with Yervoy® (ipilimumab) for the first-line treatment of adult patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) who meet certain criteria.

The combination of Opdivo® plus Yervoy® has been approved for a range of cancer treatments including for:

• Colorectal cancer in Australia, Canada, Europe, Japan, USA; and
• Hepatocellular carcinoma in Canada, Europe, Japan, Korea, Taiwan,

A number of nivolumab biosimilars are under development including Xbrane/Intas’ Xdivane™, Amgen’s ABP 206, Reliance Life Sciences’ RLS-Nivolumab, Enzene’s candidate, Boan Biotech’s BA1104, NeuClone’s candidate and Zydus’ ZRCr-4276.  In August 2025, Sandoz wound down its Phase III trial of JPB898 as a measure to streamline its biosimilar nivolumab development program following feedback from regulatory authorities regarding requirements for biosimilar approvals.

On 16 December 2025, the Australian Therapeutic Goods Administration (TGA) approved Celltrion’s Steqeyma®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), in two pre-filled pen (PFP) formulations:

• 90 mg/1 mL solution for injection pre-filled pen (500305); and
• 45 mg/0.5 mL solution for injection pre-filled pen (500306). 

Steqeyma® was first approved in Australia in September 2024 for the same strengths in pre-filled syringe presentations, as well as a 130 mg/26 ml concentrate in vial.  In August 2025, Steqeyma® became the first ustekinumab biosimilar to be PBS listed, and was subsequently launched in September 2025.

There are four other ustekinumab biosimilars approved in Australia: Amgen’s Wezlana® (January 2024) and Ajemnye® (May 2024), Samsung Bioepis’ Epyztek® (October 2024) and Alvotech/Cipla’s Uteknix® (February 2025).

Sandoz’s Ardelya®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), will be considered by PBAC at its March 2026 meeting, although it has not yet received marketing approval in Australia.  While Amgen’s Wezlana® was the first ustekinumab biosimilar recommended for PBS-listing in March 2024, Amgen is no longer proceeding with that listing.  As a result, Celltrion’s Steqeyma® was the first ustekinumab biosimilar to be PBS-listed on 1 August 2025.  Samsung Bioepis’ Epyztek® was recommended for PBS-listing at PBAC’s March 2025 meeting, but the current status of the application is recorded as “inactive”.

On 16 December 2025, China-based Mabwell announced that it has completed its first commercial shipment of its denosumab biosimilars outside China, although the destination(s) of the shipment is not disclosed in the press release.

Mabwell’s biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) are marketed in China as Mailishu® (approved March 2023 for treatment of osteoporosis in postmenopausal women at high risk of fracture) and Maiweijian™ (approved April 2024 for the treatment of giant cell tumour of the bone), respectively.

The first overseas shipment by Mabwell of the biosimilars comes shortly after Mabwell’s denosumab biosimilar licensee in Pakistan, Searle (under a July 2023 licence agreement), gained approval from Pakistan’s Drug Regulatory Authority to market and sell denosumab biosimilars in that country (announced 1 September 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 16 December 2025, Celltrion announced that it has launched Eydenzelt®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), in major European countries, including Germany, Portugal and the UK.

Eydenzelt® received European approval in February 2025 for the treatment of multiple retinal disorders, including nAMD, macular oedema following retinal vein occlusion (RVO), diabetic macular oedema (DME) and myopic choroidal neovascularisation (myopic CNV).

The launch of Eydenzelt® is the second European launch of an aflibercept biosimilar to be announced following the 23 November 2025 expiry of Regeneron’s SPC on European patent EP 1183353 (encompassing aflibercept).  Sandoz’s Afqlir® was the first aflibercept biosimilar to be launched in the UK in late November 2025.

On 13 December 2025, Biocon Biologics announced that it had reached a settlement and licence agreement with Regeneron and Bayer for Yesafili® (aflibercept) in Europe (and ROW), enabling Biocon to launch Yesafili® in the UK in January 2026 and ROW in March 2026, or earlier under certain undisclosed circumstances.  A settlement covering the US and Canada was previously agreed between the companies in April 2025, permitting a US launch in H2 2026.

Other aflibercept biosimilars currently approved in Europe include Samsung Bioepis/Biogen’s Opuviz™ (SB15) (November 2024), Formycon/Klinge’s Baiama® and Ahzantive® (January 2025), Amgen’s Pavblu® (April 2025), Alvotech/Advanz’s Mynzepli® (August 2025) and Alteogen’s Eyluxvi® (September 2025).

Litigation will continue to hold up European launches for some biosimilar sponsors.  For example, in October 2025, the Munich Regional Court granted Regeneron a permanent cross-border injunction preventing Formycon’s launch of its aflibercept biosimilar in 20 countries.  The Hague District Court also granted an injunction in October 2025 preventing Samsung Bioepis from launching its aflibercept biosimilar in the Netherlands.

The news has been better for aflibercept biosimilars in the UK, with Samsung Bioepis and Formycon/Klinge defeating injunction applications by Regeneron/Bayer in relation to their aflibercept biosimilars in October 2025.  In early November 2025, the UK High Court rejected Regeneron/Bayer’s request for an injunction to prevent UK manufacturing activities under the SPC waiver notice provisions in relation to Alvotech’s Mynzepli®.

On 15 December 2025, AstraZeneca announced that the FDA has approved the combination of Enhertu® (trastuzumab deruxtecan) with Roche’s Perjeta® (pertuzumab) for the 1st-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer.  This is the first new 1^st-line treatment approved in a decade for this indication.

Enhertu® has previously been approved as monotherapy for breast cancer including in Australia (October 2021), Japan (March 2023), China (July 2023), New Zealand (December 2023), USA (January 2025) and India (May 2025).  A biosimilar to Enhertu® is reportedly under development by Samsung Bioepis.

Roche has been fighting a rising tide of pertuzumab biosimilars including in the USA and India with other competitors on the horizon in China, Europe and Russia.