After another milestone year, here are our picks for the top-five biggest deals in the world of biosimilars in 2016: 1) As we reported in January 2016, Mylan N.V. and…
After another milestone year, here are our picks for the top-five biggest deals in the world of biosimilars in 2016: 1) As we reported in January 2016, Mylan N.V. and…
Yesterday, Coherus filed its Petitioner Reply in IPR2016-00188 (U.S. Patent 9.017,680), IPR2016-00189 (9,073,987), and IPR2016-00172 (U.S. Patent 8,889,135). Each of these patents is owned…
Here are our picks for the top-five most significant U.S. market developments in the world of biosimilars in 2016: The FDA approved three biosimilar products in 2016, compared to only…
Here are our picks for the top-five most significant legal developments in the world of biosimilars in 2016: 5) Congress passed and President Obama signed the 21st Century Cures Act….
On Tuesday, Amgen filed its supplemental brief opposing Sandoz’s petition for writ and responding to the Solicitor General’s brief, which we discussed here. In sum, the Solicitor General sided…
Today, the Supreme Court denied certiorari in Apotex v. Amgen, a closely-watched case involving the interpretation of key provisions of the BPCIA. Our most recent blog coverage can be found…
As we posted earlier this week, the Acting Solicitor General (“SG”), on December 7th, filed an amicus brief in which it (a) recommended that the Supreme Court grant Sandoz’s…
The Acting Solicitor General has just filed an amicus brief recommending that Sandoz’s cert petition and Amgen’s cross-petition be granted. The Acting Solicitor General also argues that the…
We recently reported that Amgen and Allergan had submitted an abbreviated Biologics License Application to the FDA for ABP 215, a biosimilar to Avastin® (bevacizumab). Today, the companies…
The parties in Amgen v. Sandoz (N.D. Cal.) (filgrastim, pegfilgrastim) have submitted a joint stipulation to dismiss, without prejudice, Amgen’s U.S. Patent No. 5,824,784 patent from the…