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On 2 February 2026, R-Pharm announced that the Russian Ministry of Health has approved Persinthia™, biosimilar to Genentech/Roche’s Perjeta® (pertuzumab), for the treatment of HER2-positive breast cancer.  The approval follows R-Pharm’s announcement in December 2025 at the ...

On 2 February 2026, Sandoz announced that it has launched Enzeevu®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept) 2mg, in Canada.  Enzeevu® was approved by Health Canada in October 2025 for all Eylea® indications.

Other aflibercept biosimilars approved in Cana...

On 1 February 2026, Sandoz’s Afqlir®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept) 2mg, was listed on Australia’s Pharmaceutical Benefits Scheme (PBS) in vial and pre-filled syringe presentations for all reference indications.  Afqlir® is Australia’s first afliberce...

On 30 January 2026, Celltrion announced that it has launched Avtozma®, biosimilar to Roche’s Actemra® (tocilizumab), in major European countries, including Germany, France and Spain.

Celltrion’s launch strategy in France has involved winning bids from private hospita...

At its December 2025 Intracycle Meeting (the outcomes of which were published on 30 January 2026), the Australian Pharmaceutical Benefits Advisory Committee (PBAC) recommended a broad, multi-indication PBS listing of MSD’s Keytruda® (pembrolizumab) for the treatment of adva...

On 30 January 2026, Samsung Bioepis announced that it has secured a settlement and licence agreement with Regeneron and Bayer for the commercialisation of SB15, biosimilar to Eylea® (aflibercept, 2 mg), in countries excluding the US and Canada.  The announcement comes a day...

On 30 January 2026, a Joint Stipulation of Dismissal was filed in the US District Court for the District of New Jersey dismissing all claims in the BPCIA litigation commenced by Genentech/Roche in August 2025 in relation to Shanghai Henlius/Organon’s Poherdy® (HLX11, pertuz...

On 29 January 2026, the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended authorisation of BMS’s Opdivo® (nivolumab) in combination with brentuximab vedotin for the treatment of children 5 years of age and older, adolescents and ad...

BMS has applied to the Supreme Court of India for leave to appeal against the 12 January 2026 decision of the High Court of Delhi appellate division, which allowed Zydus to launch Tishtha®, biosimilar to BMS’ Opdivo®/Opdyta®, in India pending resolution of the patent infrin...