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On 21 October 2025, Xbrane announced that the FDA has issued a Complete Response Letter (CRL) regarding its biosimilar ranibizumab, referencing Genentech’s Lucentis®.  The CRL follows the December 2024 resubmission of the BLA after the FDA issued a first CRL in April 2024 i...

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.  The product is the first biosimilar ranibizumab to be offered in a PFS presentatio...

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.

Under the agreement, Teva will marke...

On 20 October 2025, Santen Pharmaceutical announced that Santen Korea has entered into a promotion and distribution agreement in South Korea with Novartis Korea.  The agreement covers Novartis’ Beovu® (brolucizumab) and Lucentis® (ranibizumab), which will be exclusively dis...

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 o...

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 Biol...

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...

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 man...

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 recommend...