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On 26 July 2026, Roche and Genentech commenced BPCIA proceedings in the US District Court in New Jersey against Biocon in relation to Biocon’s Bmab 1500, biosimilar to Genentech’s Perjeta®.  The litigation arises from Biocon’s submission of an abbreviated Biologics License ...

On 24 July 2026, Celltrion announced that it has submitted an application for marketing approval to the European Medicines Agency (EMA) for CT-P55, biosimilar to Novartis’ Cosentyx® (secukinumab), seeking all approved reference indications.

The announcement follows C...

On 24 July 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its July 2026 meeting, including positive opinions for one biosimilar and two biopharmaceuticals.

Aurobindo Pharma subsidiary, CuraTeQ Bio...

On 24 July 2026, Outlook Therapeutics announced that the FDA has approved ONS-5010/Lytenava™ (bevacizumab-vikg) for the treatment of neovascular age-related macular degeneration (nAMD/wet AMD).  Outlook expects Lytenava™ will be available to eligible patients in the US befo...

On 23 July 2026, Samsung Bioepis published the 14th edition of its US Biosimilar Market Report, which has been released every quarter since April 2023.  The report provides an overview of the US biosimilar market and details average sales price (ASP) and wholesale acquisiti...

On 23 July 2026, Accord BioPharma announced its US launch of Osvyrti® and Jubereq® (denosumab), interchangeable biosimilars to Amgen’s Prolia® and Xgeva®, respectively.  The denosumab biosimilars are the first products of Accord developed and manufactured “end to end”...

On 22 July 2026, Medtas announced that it has launched a new in-pharmacy program (myMedtas-Care), following the 1 July 2026 listing of Wezlana®, biosimilar to Janssen’s Stelara® (ustekinumab), on the Australian Pharmaceutical Benefits Scheme (PBS).  The in-pharmacy program ...

On 22 July 2026, the Economic Times reported that Intas Pharmaceuticals has received marketing approval from India’s Central Drug Standard Control Organisation (CDSCO) for its trastuzumab emtansine biosimilar, referencing Roche’s Kadcyla®.  No launch plans have ...

On 22 July 2026, the Australian Pharmaceutical Benefits Advisory Committee (PBAC) published the agenda for its November 2026 meeting, with a number of biosimilars and biopharmaceuticals to be considered for reimbursement.

New Biosimilar Listings

PBAC will cons...

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