Read our latest updates & insights

On 1 August 2026, the Economic Times reported that the FDA has approved Dr Reddy’s biosimilar to Genentech’s Rituxan® (rituximab).  The product will be commercialised in the US by Fresenius Kabi.

The FDA approval follows a Complete Response Letter (CRL) issued to Dr ...

On 31 July 2026, judgment was published in relation to procedural matters in proceedings commenced earlier this year in the High Court of England and Wales (Patents Court) by each of Fresenius Kabi, Advanz Pharma, Accord Healthcare and Samsung Bioepis (Biosimilar Claimants)...

On 31 July 2026, Polpharma Biologics and Fresenius Kabi announced that Polpharma’s Biologics License Application (BLA) and Marketing Authorisation Application (MAA) for PB016 (vedolizumab), biosimilar to Takeda’s Entyvio®, have been accepted for review by the FDA and Europe...

On 30 July 2026, Seoul Economic Daily reported that Celltrion is partnering with Korean-headquartered G2GBIO to convert antibody drugs to subcutaneous injection formulations.  The companies have signed a strategic memorandum of understanding, including a material transfer a...

On 30 July 2026, Chicago-headquartered Meitheal Pharmaceuticals announced that the FDA has approved Garzulys™ (insulin aspart-fsan) injection, biosimilar to Novo Nordisk’s NovoLog®.  Garzulys™ is indicated to improve glycaemic control in adult and paediatric patients with d...

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...