Biocon to Re-Submit Biosimilar Applications to EMA

August 21, 2017

Biocon said it plans to re-submit applications for European approval of two cancer-treatment biosimilars as soon as it corrects serious GMP deficiencies found at a Bangalore manufacturing plant. The company said it intends to fix the problems by Sept. 30.

The applications were filed in partnership with Mylan. The companies are also in the FDA approval pipeline for biosimilars of trastuzumab and pegfilgrastim.

Originally developed by Roche and branded as Herceptin, trastuzumab is a leading breast cancer drug. Pegfilgrastim, sold as Neulasta by Amgen, is administered to chemotherapy patients to reduce the risk of infection.

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