FDA re­jects Bio­con and Vi­a­tris' Avastin biosim­i­lar af­ter in­spec­tion ques­tion marks

Af­ter the FDA found mul­ti­ple is­sues at Bio­con’s man­u­fac­tur­ing fa­cil­i­ties in Malaysia and In­dia, the agency has shot down Bio­con and Vi­a­tris’ biosim­i­lar to Avastin (be­va­cizum­ab).

In a no­ti­fi­ca­tion to the stock ex­change, biosim­i­lar gi­ant Bio­con said the com­plete re­sponse let­ter from the FDA “in­forms the need for a sat­is­fac­to­ry res­o­lu­tion of the ob­ser­va­tions made dur­ing the fa­cil­i­ty in­spec­tion con­duct­ed in Au­gust, 2022.” The FDA has al­ready ap­proved four oth­er be­va­cizum­ab biosim­i­lars dat­ing back to 2017.

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