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On 29 July 2026, Alvotech announced that the US FDA has closed its inspection of Alvotech’s manufacturing facility in Reykjavik, Iceland with the inspection classification “Voluntary Action Indicated (VAI)”.  The routine cGMP surveillance inspection was conducted in M...

On 29 July 2026, Biocon announced that it has received Notice of Compliance (NOC) approval from Health Canada for ustekinumab (Yesintek®), biosimilar to Janssen’s Stelara®, in an autoinjector pen format (45 mg/0.05mL and 90 mg/mL).

Yesintek® was first approved in Can...

On 29 July 2026, Sandoz announced that Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA) has approved Owozy® (semaglutide), a generic version of Novo Nordisk’s Ozempic®, for type 2 diabetes.  Sandoz is expecting to launch the product in the second half of 2026.

On 29 July 2026, the EPO published the Board of Appeal’s decision of 6 May 2026 upholding the Opposition Division’s 13 March 2024 revocation of EP 3 288 980, for a composition comprising nivolumab for use in a method of treating PD-L1-positive melanoma.  The patent was oppo...

On 28 July 2026, AstraZeneca announced that India’s Central Drugs Standard Control Organisation (CDSCO) has approved an indication extension for Enhertu® (trastuzumab deruxtecan), followed by taxane, trastuzumab and pertuzumab (THP)), for the neoadjuvant treatment of HER2-p...

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...