On 9 June 2025, Celltrion announced that its Qoyvolma® (CT-P43), biosimilar to J&J/Janssen’s Stelara® (ustekinumab) has received marketing approval from the European Commission (EC).  Qoyvolma® is Celltrion’s second European ustekinumab biosimilar, following Steqeyma®, which was approved by the EC in August 2024 and launched in the EU in November 2024.

Qoyvolma® received a positive opinion from the EMA’s CHMP in March 2025.  It has been approved with an additional indication to that of Steqeyma®, with moderately to severely active ulcerative colitis in adults included in its list of indications, together with adult and paediatric plaque psoriasis, active psoriatic arthritis and moderately to severely active Crohn’s disease.

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

On 5 June 2025, Formycon announced that Brazil’s ANVISA has granted marketing authorisation for Ranivisio® (FYB201), biosimilar to Genentech’s Lucentis® (ranibizumab).  Ranivisio® is the first approved Lucentis® biosimilar in Brazil.

Formycon expects that Ranivisio® will be launched in Brazil in Q4 2025 by its commercialisation partner, Biomm, with a phased market rollout of Ranivisio® to follow across Latin America.  Marketing authorisations have previously been granted in Peru, El Salvador, Honduras and the Dominican Republic and further approvals in Central and South America are planned.

FYB201 was developed by Bioeq (a JV between Formycon and Polpharma Biologics).  It has been approved in the UK (in May 2022, marketed as Ongavia® by Teva), in the US (in August 2022, marketed as Cimerli®, to which Sandoz acquired the marketing rights from Coherus in March 2024), the EU (in August 2022, marketed as Ranivisio® by Teva), Canada (in December 2023, marketed as Ranopto™ by Teva) and MENA (marketed as Ravegza® by MS Pharma).

On 5 June 2025, Alvotech and Dr Reddy’s announced that they have entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a biosimilar to MSD’s Keytruda® (pembrolizumab).

Under the agreement, Alvotech and Dr Reddy’s will be jointly responsible for developing and manufacturing the pembrolizumab biosimilar and will share all costs and responsibilities.  Subject to certain undisclosed exceptions, each company will have the right to commercialise the product globally.

There are a number of pembrolizumab biosimilars already in clinical trials, including Formycon’s FYB206 (Ph 1 commenced June 2024 in malignant melanoma), Celltrion’s CT-P51 (Ph 3 trial plan approved by FDA in August 2024), Bio-Thera’s BAT3306 (Ph 1/3 in nsNSCLC commenced in July 2024), Amgen’s ABP 234 (Ph 3 in nsNSCLC initiated May 2024), Samsung Bioepis’ SB27 (Ph 3 in metastatic nsNSCLC commenced April 2024) and Sandoz’s GME751 (Ph 1 commenced in May 2024).  In September 2024, Shanghai Henlius Biotech received approval in China for a clinical trial of its pembrolizumab biosimilar, HLX17.

On 4 June 2025, Sandoz Australia published a white paper entitled “Pioneering Access for Patients Through Biosimilar Medicines” which outlines proposals for reducing healthcare costs and expanding patient access to biosimilars in Australia.  The white paper is the outcome of a summit of stakeholders held in Canberra, Australia on 10 February 2025.

Noting that “Australia is behind most of its international counterparts in biosimilar uptake in retail pharmacies”, the white paper sets out four key policy proposals explored at the February summit:

• lowering patient co-payments for biosimilars;
• mandating biosimilars for new, treatment naïve patients;
• reducing administrative burdens for clinicians (e.g. removing Pharmaceutical Benefits Scheme (PBS) authority requirements once biosimilar uptake surpasses 70%); and
• reinvesting savings from increased biosimilar uptake into a chronic disease future fund.

The white paper suggests that such policy reforms could result in greater affordability and access to medicines for patients, increased competition and PBS savings, reduced prescribing complexity for healthcare professionals and more sustainable funding for new medicines and long-term health priorities.

On 4 June 2025, Alvotech announced that it has completed the acquisition of Xbrane’s Swedish R&D operations, as well as XB003, biosimilar to UCB’s Cimzia® (certolizumab pegol), in a deal worth US$28.9m.  The deal was initially announced by Alvotech in March 2025, and was approved by Xbrane’s board on 14 April 2025.

The acquisition comes a week after Alvotech expanded its partnership with Advanz Pharma to cover three additional biosimilar candidates in Europe.  The products covered by the agreement are biosimilars to Novartis’ Ilaris® (canakinumab) and Kesimpta® (ofatumumab), and a third, undisclosed early-stage biosimilar.

On 2 June 2025, Biocon announced that its generic liraglutide has been approved by India’s Central Drugs Standard Control Organisation (CDSCO) in 6 mg/ml solution for injection in pre-filled pen and cartridge.

Biocon’s liraglutide, the generic version of Novo Nordisk’s Victoza®, is indicated for the treatment of insufficiently controlled Type 2 diabetes mellitus in adults, adolescents and children aged 10 years and above, as an adjunct to diet and exercise.  The CDSCO approved Biocon’s liraglutide under the recently formulated 101 route that enables recognition of approvals granted by established and referenced serious regulatory authorities.

Biocon’s liraglutide was the first generic to Victoza® to be approved in the UK in March 2024, and was subsequently launched in February 2025.  In December 2024, Biocon and its European partner, Zentiva, received approval for liraglutide in the European Union.  The first EU-approved generic liraglutide was Adalvo’s liraglutide pre-filled pen in June 2024.  Teva Pharmaceuticals launched the first authorised generic version of Victoza® in the US in June 2024.

On 2 June 2025, ChosunBiz reported that Celltrion has launched Avtozma®, biosimilar to Roche’s Actemra® (tocilizumab), in Korea.  Avtozma® was approved by Korea’s Ministry of Food and Drug Safety in December 2024 for the same indications as Actemra®.

Just a few days earlier, the Therapeutic Good’s Administration (TGA) approved Avtozma® as the first 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).

On 2 June 2025, Outlook Therapeutics announced that it has launched Lytenava™ (bevacizumab gamma) in the UK and Germany, for the treatment of nAMD.  Lytenava™ is the first and only authorised ophthalmic formulation of bevacizumab in the EU and UK.

Lytenava™ (ONS-5010, bevacizumab-vikg/bevacizumab gamma) received marketing authorisation in the EU in May 2024 and was approved in the UK in July 2024 following submission of a marketing authorisation application to the MHRA under the International Recognition Procedure (IRP).  Outlook Therapeutics resubmitted a BLA to the US FDA for ONS-5010 in February 2025 after the FDA issued a complete response letter in 2023.

Outlook Therapeutics has entered into a strategic collaboration with Cencora in relation to the commercial launch of Lytenava™ globally.  In Europe, Cencora provides launch support including pharmacovigilance, regulatory affairs, quality management, market access support, importation, third-party logistics, distribution and field solutions.

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

On 2 June 2025, Sandoz announced its US launch of Wyost® and Jubbonti®, biosimilars to Amgen’s Xgeva® and Prolia® (denosumab), respectively.  Wyost® and Jubbonti® are the first and only interchangeable denosumab biosimilars to be approved (in March 2024), and launched, in the US and have the same indications, dosage forms and routes of administration as Amgen’s denosumab products.

The US launch of Sandoz’s denosumab biosimilars follows 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 Wyost® and Jubbonti® from 31 May 2025.

Wyost® and Jubbonti® are approved in Europe (May 2024) and Australia (August 2024) and, in December 2024, they were recommended for listing on Australia’s Pharmaceutical Benefits Scheme (PBS).

There are currently three other sponsors with denosumab biosimilars approved in the US: Fresenius Kabi’s Conexxence® and Bomyntra® (March 2025), Celltrion’s Stoboclo® and Osenvelt® (March 2025) and Samsung Bioepis’ Ospomyv™ and Xbryk™ (February 2025).  Amgen settled patent litigation against Celltrion regarding denosumab biosimilars in January 2025, permitting US launch of Celltrion’s denosumab biosimilars from 1 June 2025 (Celltrion’s denosumab biosimilars have not yet been launched in the US at the date of this report).  In March 2025, Amgen entered into a global settlement of its patent infringement litigation with Fresenius Kabi, allowing US launch of Fresenius’ denosumab biosimilars in mid-2025 (the precise date is unknown).  BPCIA litigation commenced by Amgen against Samsung Bioepis and Accord/Intas regarding their denosumab biosimilars remains pending.

On 30 May 2025, Australia’s Therapeutic Good’s Administration (TGA) approved Celltrion’s Avtozma®, biosimilar to Roche’s Actemra® (tocilizumab), across 5 products:

• Injection concentrated vial: 80mg/4ml (444940), 200mg/10ml (444939) and 400mg/20ml (444943); and
• Solution for injection pre-filled pen: 162mg/0.9ml (444942), and 162mg/0.9ml (AVTPen Autoinjector) (444941).

Avtozma® has been approved for the same indications as Actemra® and is the first tocilizumab biosimilar to be approved 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).