Biocon/Mylan biosimilar progam in manufacturing setback

10 July 2017

Indian drugmaker Biocon (BSE: 532523) closed 4% down at 322.05 Indian rupees on Monday after news emerged in relation to the company’s marketing authorization applications (MAAs) to sell biosimilar versions of three big-selling drugs.

On behalf of the European Medicines Agency (EMA), the French National Agency for Medicines and Health Products Safety (ANSM) conducted pre-approval inspection audits of Biocon’s Bangalore drug substance and drug product sites related to the pending applications for biosimilars referencing trastuzumab, pegfilgrastim and insulin glargine (pen assembly only).

The original version of trastuzumab is sold by Genentech, a unit of Swiss pharma major Roche (VTX: ROG), under the name Herceptin, and is used to treat certain HER2-positive breast and gastric cancers, while pegfilgrastim's original, called Neulasta, is a cancer product belonging to Amgen, and the insulin glargine biosimilar references Lantus, a diabetes treatment from France’s Sanofi (Euronext: SAN).

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