Recent BioBlast® Updates

Formycon & Teva Launch First Biosimilar Ranibizumab PFS in EU

Oct 21, 2025

On 21 October 2025, Formycon and Teva jointly announced the European launch of FYB201/Ranivisio®, biosimilar to Genentech’s Lucentis® (ranibizumab), in pre-filled syringe (PFS) presentation.

Teva & Prestige Enter EU Licence for Biosimilar Trastuzumab

Oct 20, 2025

On 20 October 2025, Teva announced that it has entered into a licensing agreement with Prestige Biopharma for the commercialisation of Tuznue®, biosimilar to Roche’s Herceptin® (trastuzumab), across a majority of European markets.

Santen Pharmaceuticals Inks South Korea Deal with Novartis for Lucentis® and Beovu®

Oct 20, 2025

On 20 October 2025, Santen Pharmaceutical announced that Santen Korea has entered into a promotion and distribution agreement in South Korea with Novartis Korea.

Celltrion’s US Launch of Biosimilar Aflibercept Set for December 2026 Following Regeneron Settlement

Oct 20, 2025

On 20 October 2025, Regeneron announced that it has settled its BPCIA litigation with Celltrion in relation to Eydenzelt®/CT-P42, biosimilar to Regeneron’s Eylea® (aflibercept, 2mg). Under the terms of the settlement, Celltrion is permitted to launch Eydenzelt® in the US on 31 December 2026.

Samsung Biologics’ Biosimilar Spin-Off Approved at October 2025 EGM

Oct 17, 2025

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.

PBAC Recommends BMS’ Proposal for Broad Opdivo® (Nivolumab) & Yervoy® (Ipilimumab) Funding

Oct 17, 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.

Biocon Partners with Civica on Insulin Glargine Biosimilar; US$11 per Pen Pricing in California

Oct 16, 2025

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.

Positive CHMP Opinion for Paediatric Plaque Psoriasis Indication Extension for J&J’s Guselkumab

Oct 16, 2025

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).

Formycon/Klinge Partners with Actor in AU and Megalabs in LATAM for Biosimilar Aflibercept

Oct 16, 2025

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.

India’s SEC Approves Phase I/III Trial for Reliance Life Science’s Biosimilar Nivolumab

Oct 14, 2025

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).

Regeneron to Submit Additional Manufacturer to FDA for Eylea HD® Due to Catalent FDA Action

Oct 13, 2025

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.

India’s SEC Instructs Enzene to Revise Ph III Trial Protocol for Biosimilar Nivolumab

Oct 12, 2025

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).

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Recent BioBlast® Updates

Formycon & Teva Launch First Biosimilar Ranibizumab PFS in EU

Teva & Prestige Enter EU Licence for Biosimilar Trastuzumab

Santen Pharmaceuticals Inks South Korea Deal with Novartis for Lucentis® and Beovu®

Celltrion’s US Launch of Biosimilar Aflibercept Set for December 2026 Following Regeneron Settlement

Samsung Biologics’ Biosimilar Spin-Off Approved at October 2025 EGM

PBAC Recommends BMS’ Proposal for Broad Opdivo® (Nivolumab) & Yervoy® (Ipilimumab) Funding

Biocon Partners with Civica on Insulin Glargine Biosimilar; US$11 per Pen Pricing in California

Positive CHMP Opinion for Paediatric Plaque Psoriasis Indication Extension for J&J’s Guselkumab

Formycon/Klinge Partners with Actor in AU and Megalabs in LATAM for Biosimilar Aflibercept

India’s SEC Approves Phase I/III Trial for Reliance Life Science’s Biosimilar Nivolumab

Regeneron to Submit Additional Manufacturer to FDA for Eylea HD® Due to Catalent FDA Action

India’s SEC Instructs Enzene to Revise Ph III Trial Protocol for Biosimilar Nivolumab

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