On 17 October 2025, Samsung Biologics announced that its biosimilar operations will be spun off into a new holding entity, Samsung Epis Holdings, after the proposal was approved by shareholders at an Extraordinary General Meeting.

Following the spin-off, Samsung Biologics will focus on its contract development and manufacturing (CDMO) business, while Samsung Epis Holdings will become the parent company of the biosimilar unit, Samsung Bioepis, supporting its R&D and also exploring new growth opportunities including development of bio-platform technologies.

According to materials published by Samsung Biologics in advance of the Extraordinary General Meeting, the spin-off is partly driven by client concerns of potential conflicts of interest with a perception that Samsung Biologics was operating a competing biosimilar business to Samsung Bioepis.  Another factor influencing the separation is valuation limitations due to differences between order-based (Samsung Biologics) and R&D-driven (Samsung Bioepis) models.

The spin-off is tentatively expected to take effect on 1 November 2025, with both entities to be relisted on the Korean Exchange on 24 November 2025.

In a significant breakthrough, the Australian Pharmaceutical Benefits Advisory Committee (PBAC) has recommended a broad, multi-indication listing for BMS’ Opdivo® (nivolumab) and Yervoy® (ipilimumab) in advanced or metastatic cancers.  The novel recommendation is the result of development work by BMS and the Department of Health, Disability and Ageing to overcome previous concerns with broad listings of this type.

The proposal includes a risk-sharing arrangement and is supported by consumer and clinical representative bodies.  The recommended listing would allow clinicians to apply clinical judgment and discretion in using the medicines according to the best available evidence at the time, including for rare cancers for which regulatory submissions are unlikely.  The listing would also remove the once in a lifetime limitation for these medicines when used for advanced or metastatic cancers.  The PBAC hopes this approach may serve as a framework for future, similar proposals of this kind.  It asked that the listing be reviewed after three years to ensure the use remained consistent with its intention.

The PBAC’s recommendation comes just two months after it rejected MSD’s proposal for a multi-indication (broad) listing for Keytruda® (pembrolizumab) in advanced or metastatic cancers.  In that case, PBAC considered that because the proposed funding model “was restricted to the indications for which pembrolizumab was registered with the Therapeutic Goods Administration” it “would not provide access to some patient groups in which there is a significant unmet clinical need, such as rare cancers.”

At least Amgen, Sandoz, Xbrane/Intas, Enzene and Reliance Life Sciences have nivolumab biosimilars in development, and Zydus received regulatory approval for its nivolumab biosimilar from India’s CDSCO in July 2024.  In April 2025, Sandoz and Shanghai Henlius Biotech announced a global collaboration agreement for an ipilimumab biosimilar.

On 16 October 2025, Biocon Biologics announced that it is has expanded its collaboration with US-based non-profit pharmaceutical firm Civica, Inc. to supply a new insulin glargine medicine in the United States.

Under the exclusive agreement, Biocon Biologics will manufacture and supply insulin glargine to Civica, and Civica will commercialise the product under Biocon’s existing marketing approval.  The product will be promoted and sold under a separate Civica label and trade dress.

On the same day, Governor of California, Gavin Newsom, announced that the State of California will be offering the Civica insulin glargine product under the State-owned CalRx® brand at a maximum cost of $11 per pen.

Biocon’s Semglee® was the first biosimilar approved in the Unites States as interchangeable to Sanofi’s Lantus® (insulin glargine) (July 2021).  Eli Lilly’s insulin glargine biosimilar, Rezvoglar®, was US-approved in December 2021.  In July 2025, Biocon announced that the FDA approved Kirsty™ (insulin aspart-xjhz) as the first and only interchangeable biosimilar to Novo Nordisk’s NovoLog®.

On 16 October 2025, the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the highlights of its October 2025 meeting, including a positive opinion for an indication extension to J&J/Janssen’s Tremfya® (guselkumab).  The recommended extension is the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy.

Tremfya® is already approved in Europe for moderate to severe plaque psoriasis and active psoriatic arthritis in adult patients.  It has since received European approval for adults with moderately to severely active ulcerative colitis (April 2025) and for adults with moderately to severely active Crohn’s disease (May 2025).

The CHMP’s positive opinion follows the FDA’s September 2025 approval of a Tremfya® paediatric indication extension for the treatment of severe plaque psoriasis and active psoriatic arthritis in children aged six years and older weighing at least 40 kg.

Biosimilar development of guselkumab is underway.  In September 2025, Polpharma and MS Pharma announced that they entered into a licensing agreement for the commercialisation of PB019, biosimilar guselkumab, in the MENA region.  In 2023, Alvotech and Advanz Pharma entered into a partnership agreement to commercialise a proposed guselkumab biosimilar in the EU, UK and Switzerland.

On 16 October 2025, Formycon announced that Klinge Biopharma, the exclusive holder of the global commercialisation rights for Formycon’s FYB203, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), has entered exclusive licence agreements with Actor Pharmaceuticals and Uruguay-based Megalabs S.A. for the commercialisation of FYB203 in Australia and Latin America, respectively.

Under the agreements, Klinge is eligible to receive upfront and milestone payments and royalties on net sales.  Formycon will participate in all payment streams to Klinge, in the mid-single digit to low-double digit percentage range and will receive additional payments for organising the commercial market supply on behalf of Klinge.

According to Formycon, a regulatory application for FYB203 has been submitted to the Australian Therapeutic Goods Administration (TGA), while Formycon is working closely with Megalabs to prepare marketing applications for Latin American countries.

The agreements follow semi-exclusive commercialisation agreements between Klinge and Horus Pharma (September 2025) and Klinge and Teva Pharmaceuticals (January 2025) for FYB203, covering major parts of Europe (excluding Italy) and Israel.  Horus will market the product as Baiama®, while Teva will market it as Ahzantive®.  In June 2025, Klinge entered an exclusive licence agreement with Valorum for commercialisation of FYB203 in the US and Canada.

FYB203/Ahzantive® was approved by the FDA in June 2024 and is set to launch in the US in Q4/2026 following settlement of BPCIA litigation between Formycon and Regeneron in October 2025.  The biosimilar may launch in the UK in November 2025, following a February 2025 approval by the MHRA and a failed UK preliminary injunction bid by Regeneron in October 2025 (which is subject to any appeal).  The situation is less clear in Europe, where, on 25 September 2025, the Munich Regional Court granted Regeneron and Bayer a cross-border preliminary injunction (PI) preventing Formycon from launching FYB203 in a number of European countries, including Germany.  FYB203 received European marketing approval in January 2025 as Baiama® and Ahzantive®.

On 14 October 2025, Medical Dialogues reported that India’s Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has approved Reliance Life Sciences’ Phase I/III clinical trial for its biosimilar nivolumab (R-TPR-067 or RLS-Nivolumab).

The trial is intended to establish comparability in efficacy, safety, pharmacokinetics, and immunogenicity between R-TPR-067 and the reference product, BMS’ Opdivo® (sold as Opdyta® in India), administered intravenously in patients previously treated for locally advanced or metastatic non-small cell lung cancer.

This puts Reliance ahead of Enzene in their respective efforts to have a nivolumab biosimilar approved in India, as the SEC requested Enzene to revise its Phase III trial protocol.  However, both companies lag behind Zydus, which had its nivolumab biosimilar approved in India in July 2024, but which has since faced injunction proceedings before the Delhi High Court.

Amgen, Sandoz and Xbrane/Intas also have nivolumab biosimilars in development.

On 13 October 2025, Regeneron announced that it has been notified by Catalent Indiana, LLC, which was acquired by Novo Nordisk and is the manufacturer filler included in the supplemental BLA for Regeneron’s high dose (8mg) formulation of Eylea® (aflibercept), that Catalent received an “official action indicated” classification from the FDA on 9 October 2025.  This classification indicates that the facility is in an “unacceptable state of compliance” after an FDA inspection.

Regeneron’s Eylea HD® (aflibercept, 8mg) is already approved in the US in a vial form for nAMD, DME and diabetic retinopathy (August 2023).  However, Regeneron has filed an sBLA in the US for the use of Eylea HD® to treat macular oedema following retinal vein occlusion (RVO) and for an extension of the dosing schedule to include every 4-week dosing across approved indications.  Regeneron has also filed a US regulatory submission for Eylea HD® in a pre-filled syringe.

In August 2025, the FDA extended its target action date for these regulatory submissions (to Q4/2025) as a result of FDA observations based on an inspection at Novo Nordisk’s Catalent filling site.

According to Regeneron, while Catalent continues to work with the FDA to resolve the outstanding compliance issues, within the next 3 months, Regeneron is planning to submit an application to the FDA to include an additional manufacturing filler in the Eylea HD® BLA.

Eylea HD® (known as Eylea™ 8mg in Europe) 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® 8mg for intravitreal injection is approved for nAMD and DME including in the EU (January 2024), Japan (January 2024), UK (January 2024) and Australia (June 2024).  Eylea® 8mg pre-filled syringe (OcuClick) was approved in Europe (September 2024), Australia (October 2024) and Korea (August 2025).  In addition to the US application, Regeneron/Bayer have submitted marketing authorisation applications for Eylea® 8mg for the treatment of patients with macular oedema following RVO in Japan (May 2025) and Europe (April 2025).

Alvotech is developing AVT29, a biosimilar to Regeneron’s Eylea® 8mg.  Teva holds commercialisation rights for AVT29 (and AVT06, aflibercept 2mg) in the US.  In June 2024, Alvotech entered into an agreement with Advanz Pharma in relation to the commercialisation of AVT29 (and AVT06) in Europe.

On 12 October 2025, Medical Dialogues reported that India’s Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has requested Alkem subsidiary, Enzene Biosciences, to revise its proposed Phase III clinical trial protocol for biosimilar nivolumab (injection 100mg/10mL vial).

According to the report, Enzene requested permission to conduct a multicentre, Phase III trial comparing its biosimilar nivolumab with BMS’ Opdivo® (nivolumab) in adults with recurrent locoregional or metastatic squamous cell carcinoma of the head and neck, progressing on or after platinum-based therapy.

The SEC recommended a number of modifications to the protocol, including narrowing the non-inferiority margin used for sample size calculation and adding provisions for reporting safety data from the initial 20% of enrolled subjects.  Enzene has been instructed to submit a revised protocol incorporating the changes recommended by the SEC.

At least one other nivolumab biosimilar has already received regulatory approval in India, with Zydus’ biosimilar approved in July 2024 for locally advanced or metastatic non-small cell lung cancer, and conditional approval for all other approved indications of BMS’ Opdivo®.  Amgen, Sandoz and Xbrane/Intas also have nivolumab biosimilars under development.

On 10 October 2025, Celltrion announced that the FDA has approved Eydenzelt® (CT-P42), biosimilar to Regeneron/Bayer’s Eylea® (aflibercept 2mg), for treating nAMD, macular oedema following retinal vein occlusion, diabetic macular oedema and diabetic retinopathy.  The launch date for the product remains uncertain given pending BPCIA litigation brought by Regeneron against Celltrion regarding Eydenzelt®.

Eydenzelt® is the sixth aflibercept (2mg) biosimilar to be approved in the US following: Sandoz’s Enzeevu™ (August 2024), Amgen’s Pavblu™ (August 2024) Formycon/Klinge’s Ahzantive®/FYB203 (June 2024), Biocon’s Yesafili™ (May 2024) and Samsung Bioepis’ Opuviz™/SB15 (May 2024).

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

Launches of other US-approved aflibercept biosimilars have been delayed by BPCIA litigation brought by Regeneron.  However, the following proceedings have now 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 settlement and licence agreements were announced in September 2025 and October 2025, respectively.

Preliminary injunctions were granted, and remain in place, preventing US biosimilar aflibercept launches by Samsung Bioepis (14 June 2024, upheld on appeal on 29 January 2025) and Celltrion (June-July 2024, upheld on appeal on 5 March 2025).

Eydenzelt® was the fifth approved aflibercept biosimilar in Europe, in February 2025 (but has not yet launched), and received Korean approval in May 2024.  In Australia, Eydenzelt® was approved solely for myopic CNV on 31 March 2025.  However, in July 2025, Celltrion filed an application with the TGA to expand Eydenzelt®’s indications to all those of Eylea®.  Eydenzelt® will be considered for reimbursement at the November 2025 meeting of Australia’s Pharmaceutical Benefits Advisory Committee (PBAC).

On 9 October 2025, New Zealand’s Medsafe approved Celltrion’s Steqeyma®, biosimilar to Janssen’s Stelara® (ustekinumab), in vial and pre-filled syringe presentations, making Steqeyma® the first ustekinumab biosimilar approved in New Zealand.

Celltrion’s Steqeyma® has been approved and launched in a number of regions, including Korea (approved June 2024), Canada (approved July 2024, launched August 2024), the EU (approved September 2024, launched November 2024), the UK (approved September 2024, launched December 2024), Australia (approved September 2024, launched September 2025), the US (approved December 2024, launched March 2025), and Japan (approved March 2025, launched July 2025).

In August 2025, Steqeyma® became the first ustekinumab biosimilar to be listed on Australia’s Pharmaceutical Benefits Scheme (PBS).