- The FDA has rejected a marketing application for a biosimilar version of cancer therapy bevacizumab that Viatris ( NASDAQ: VTRS ) submitted, the U.S. drugmaker's partner in India Biocon, announced.
- Bevacizumab is the active ingredient of Roche's ( OTCQX:RHHBY ) ( OTCQX:RHHBF ) cancer therapy, Avastin which generated CHF 2.1B sales in 2022 globally.
- Issuing a so-called Complete Response Letter (CRL) regarding Viatris' ( VTRS ) Biologics License Application (BLA), the FDA has cited the need to resolve manufacturing issues found in a facility inspection in August.
- The companies have responded to the regulatory concerns and "are confident of addressing the observations within the stipulated timeframe ," Biocon said, adding that the CRL did not indicate issues about scientific data in the BLA.
- In early 2022, Biocon agreed to purchase Viatris' ( VTRS ) biosimilar assets in a cash-and-stock deal worth up to ~$3.3B.
- "Viatris isn't a very exciting business for a lot of investors," Seeking Alpha contributor Valkyrie Trading Society argued in October, adding that Biocon might have found its value "quite a lot more than where it's currently trading."
For further details see:
Viatris hit with FDA snub for cancer biosimilar