Year in Review: Top Five Events in Biosimilars in 2015

2015 was a milestone year for biosimilars in the U.S. It was also our first year bringing you the latest biosimilars news and analysis.

Here are our picks for the top-five most significant events in the world of biosimilars this year:

5) 2015 saw a marked increase in inter partes review petitions for patents related to biologic drugs (see, for example, our posts here, here, here, here, and here), as potential biosimilar makers increasingly sought to use the PTAB as a forum to clear the way for new biosimilar products.

4) December 10, 2015: In the first decision to interpret the BPCIA patent dispute resolution provisions post-Amgen v. Sandoz, the District of Florida ruled in Amgen v. Apotex that the 180-day notice of commercial marketing set forth in the BPCIA cannot be given before FDA approval even if the biosimilar applicant complies with the “patent dance.”

3) July 21, 2015: The Federal Circuit issued its landmark opinion in Amgen v. Sandoz, the first major Federal Circuit decision interpreting key provisions of the BPCIA. The court’s decision was split: the “patent dance” is “optional,” but notice of commercial marketing can only be given after FDA approval.

2) October 5, 2015: The United States and eight other countries reached an agreement on the Trans-Pacific Partnership. Once enacted, the intellectual property provisions of the TPP promise to play a major role in the biosimilars industry for years to come.

1) September 3, 2015: Sandoz launched Zarxio, a biosimilar version of Amgen’s Neupogen® (filgrastim). Zarxio is the first biosimilar product to be marketed in the United States.

And finally, on January 12, 2015, Goodwin Procter published Biosimilars: A Guide to Regulatory and Intellectual Property Issues, a detailed guide to regulatory approval pathways and intellectual property issues for biologic drug products. Look out for an updated version early in 2016.

Happy New Year from all of us at Big Molecule Watch, and we look forward to another exciting year of biosimilars industry news and analysis in 2016!