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On 24 April 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its April 2026 meeting, including positive opinions for one biosimilar and for extended indications of 9 already approved medicines.

Inta...

During its investor call on 22 April 2026, Amneal confirmed that, following its acquisition of Kashiv Biosciences, it is expecting to have 6 biosimilars launched in the US by 2027.  This includes:

biosimilars that are already on the market: Alymsys® (bevacizumab) (...

At its meeting on 22 April 2026, the Subject Expert Committee (SEC) under India’s Central Drugs Standard Control Organisation (CDSCO) recommended approval of Enzene’s Phase 3 clinical trial to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of biosimilar ...

On 22 April 2026, Amneal Pharmaceuticals and Kashiv BioSciences jointly announced that Amneal will acquire 100% of Kashiv BioSciences.  The deal (which is subject to approval by Amneal shareholders and regulatory authorities) is expected to close in the second half of 2026....

On 22 April 2026, Regeneron and Sanofi announced that Dupixent® (dupilumab) has been approved by the FDA for the treatment of children aged 2 to 11 years with chronic spontaneous urticaria (CSU) and inadequate response to histamine-1 antihistamine (H1AH) treatment.  This ap...

On 17 December 2025, Bristol Myers Squibb announced that Canada’s Drug Agency (CDA-AMC) has issued a positive reimbursement recommendation for Opdivo® (nivolumab) in combination with Yervoy® (ipilimumab) for the first-line treatment of adult patients with unresectable or me...

On 21 April 2026, Celltrion announced that the intravenous (IV) formulation of Steqeyma® (ustekinumab), biosimilar to Janssen’s Stelara®, has been approved in Japan.  The newly approved formulation adds to Celltrion’s subcutaneous (SC) formulation of Steqeyma®, which was la...