10:31 AM
Nov 09, 2018
 |  BC Week In Review  |  Clinical News  |  Regulatory

Sandoz gives up on Rituxan biosimilar in U.S.

With two competing biosimilars under FDA review, Sandoz will no longer seek U.S. approval of GP2013, its biosimilar of cancer and autoimmune drug Rituxan/MabThera rituximab from Roche (SIX:ROG; OTCQX:RHHBY).

The unit of Novartis AG (NYSE:NVS; SIX:NOVN) said Friday it will not resubmit a BLA for GP2013, which received a complete response letter from FDA in May. The company said it believes "patient and marketplace needs in the U.S. will be satisfied before we can generate the...

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