Mi­cro­cap's ef­fort to take on Eylea with Avastin biosim­i­lar faces sig­nif­i­cant FDA road­block

A small biotech try­ing to de­vel­op an Avastin biosim­i­lar to treat wet AMD has run in­to a set­back.

Out­look Ther­a­peu­tics with­drew its BLA for be­va­cizum­ab, the ac­tive com­pound in Roche/Genen­tech’s Avastin can­cer ther­a­py, af­ter the FDA re­quest­ed ad­di­tion­al in­for­ma­tion to com­plete the ap­pli­ca­tion, the biotech said Tues­day. Out­look plans to re­sub­mit its BLA by Sep­tem­ber of this year.

“We re­main con­fi­dent in ONS-5010 and its po­ten­tial to be the first FDA-ap­proved oph­thalmic for­mu­la­tion of be­va­cizum­ab that avoids the pub­lic health risk to pa­tients of off-la­bel treat­ment,” CEO Rus­sell Tre­nary said in a state­ment.

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