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Will GMP Lapses Stall Biocon-Mylan’s Biosimilars Build-Up?

 
• By Anju Ghangurde

Compliance deviations flagged by French regulator ANSM at Biocon’s Indian site have raised questions around commercialization timelines in the EU for the firm and partner Mylan’s biosimilars, including trastuzumab. The news comes ahead of an FDA advisory panel review later this week for the product. Biocon, though, appears confident of setting compliance woes right quickly.

Shares of Biocon Ltd. were on a tailspin on the Bombay Stock Exchange in early trade on July 10 after a pre-approval inspection by the French regulator, ANSM, flagged compliance deficiencies at its Bommasandra site in Bangalore for three biosimilars - pegfilgrastim (Fulphila), trastuzumab (Ogivri) and insulin glargine (Semglee).

The ANSM inspection raised 35 deficiencies, including 11 “major” ones such as those pertaining to OOS (out-of-specification) results management, cross...

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