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Biocon Biologics on Tuesday said it has inked a settlement and licensing pact with Regeneron, paving the way to commercialise its biosimilar product Yesafili in the US. Yesafili, a vascular endothelial growth factor (VEGF) inhibitor used to treat several types of ophthalmology conditions, is a biosimilar of its reference product Eylea (aflibercept). Biocon Biologics and Regeneron executed the settlement agreement to dismiss the pending appeal at the US Court of Appeals for the Federal Circuit (USCAFC) and the pending litigation at the US District Court for the Northern District of West Virginia, Clarksburg Division, Biocon Biologics said in a statement. The agreement enables the company, a unit of Biocon Ltd, to launch its product in the US in the second half of 2026 or earlier in certain circumstances, it added. The terms of the settlement are confidential, it stated. "This settlement clears the path for Biocon Biologics to be among the first to bring a reliable, high-quality ..
Central Drugs Standard Control Organisation (CDSCO) has found 41 drug samples tested in the central drug laboratories in November as 'not of standard quality' (NSQ), official sources said. Besides, 70 drug samples tested by the state drugs testing laboratories have also been identified as NSQ in November, they said. Identification of drug samples as NSQ is done based on failure of the drug sample in one or the other specified quality parameters. "The failure is specific to the drug products of the batch tested by the government laboratory and it does not warrant any concerns on the other drug products available in the market," an official said. Two drug samples were identified as spurious drugs in November. Out of the two samples, one was picked by Bihar Drugs Control Authority and the other by CDSCO, Ghaziabad, the sources said. The drugs were made by unauthorised and unknown manufacturers, using brand names of other companies. Action to identify NSQ and spurious medicines is ta