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FDA Reviewing Bevacizumab Biosimilar

Gina Columbus @ginacolumbusonc
Published: Thursday, Mar 05, 2020

The FDA has accepted a biologics license application for a proposed biosimilar for bevacizumab (Avastin), according to an announcement by Mylan during its fourth quarter 2019 earnings call.

In the fourth quarter 2019 earnings call, Mylan also announced that it had submitted a European application for the bevacizumab biosimilar, adding that it is currently in the validation stage with authorities.

References

  1. Mylan Launches Biosimilar Bevacizumab, ABEVMY, in India [news release]: Bengaluru, India. Published November 27, 2017. https://bit.ly/3anI3Ee. Accessed March 5, 2019.
  2. Socinski MA, Hummel M, Bosje T, et al. A bioequivalence study of proposed bevacizumab biosimilar, MYL-1402O (A) vs EU-Avastin (B) and US-Avastin (C). J Clin Oncol. 2017;35(suppl_15). doi: 10.1200/JCO.2017.35.15_suppl.e14034

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