More Questions As Biocon Pulls EU Filings For Two Biosimilars

Biocon and partner Mylan have withdrawn the European application for their biosimilar trastuzumab and pegfilgrastim in the backdrop of compliance blips at Biocon’s Indian site, raising critical questions on how soon things can be set right in an increasingly competitive scenario.

Domino effect — GMP ISSUES HAVE DENTED BIOCON'S BIOSIMILARS BUILD-UP

Investors slammed Biocon Ltd. on Indian bourses after the firm and partner Mylan NV retracted applications for their biosimilar trastuzumab and pegfilgrastim in the EU in the backdrop of manufacturing compliance lapses, though Biocon has underscored that it was only following the requisite regulatory procedure.

A pre-approval inspection by the French regulator, ANSM, had earlier flagged compliance deficiencies at Biocon’s Bommasandra site in Bangalore for...