Biocon and Mylan Team Up for Biosimilar Regulatory Filings

Biocon, a prominent Indian biopharma company, entered into a partnership with Mylan in 2009 for joint research and development of biosimilars. That partnership now appears to be yielding results.  The companies expect to submit regulatory filings in both the U.S. and EU 2016: trastuzumab, pegfilgrastim, adalimumab, and insulin glargine.

As Big Molecule Watch has reported, pegfilgrastim is proving to be a very popular early biosimilar play. Sandoz and Coherus announced that they plan to file applications for pegfilgrastim biosimilars this month, and pegfilgrastim is the bioisimilar at issue in Amgen v. Apotex, pending appeal at the Federal Circuit.