Welcome to the Big Molecule Watch!

Big Molecule Watch will be posting updates and analyses on regulatory issues, litigation, legislation, and other news in the ever-developing world of biosimilars. The editors of this blog have collectively been watching and engaging with the world of biosimilars (“big molecules”) since before the inception of the biosimilar industry in the U.S., and we’re excited to share the observations of our active watch on this new forum. If you’re looking for a primer on biologics, check out our background post introducing the world of biologics, biosimilars, and the Biologics Price Competition and Innovation Act (“BPCIA”). We’ve also collected (and will continue to update) some reference documents that might be of interest to visitors of this blog—you can find them under the “Links” section to the right of this page.
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Year in Review: Top Five Legal Developments of 2017

Amgen v. Apotex (pegfilgrastim)  •  Amgen v. Sandoz (filgrastim)  •  Amgen v. Sandoz (pegfilgrastim)  •  Biosimilar News  •  BPCIA and Related U.S. Statutes  •  Interchangeability  •  Legislation Tracker  •  Patent Dance
Here are our picks for the top-five most significant legal developments regarding biosimilars in 2017: 5.  In January 2017, the FDA released a draft guidance on biosimilar interchangeability, entitled “Considerations in Demonstrating Interchangeability With a […]

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