Amgen today announced the submission of its first biosimilar application to FDA. The application seeks approval for a biosimilar version of Humira®(adalimumab). As we’ve covered extensively, Amgen is the biologic reference product sponsor and plaintiff in a number of BPCIA cases: Amgen v. Sandoz, Amgen v. Hospira, and Amgen v. Apotex. This is the first time Amgen has formally appeared on…
On Friday, November 16, 2015, Apotex filed its brief in opposition to Amgen’s motion for a preliminary injunction in Amgen v. Apotex. As we’ve discussed previously here, Amgen has moved to enjoin Apotex from marketing its yet-to-be-approved Neulasta biosimilar until at least 180 days after FDA approval. Amgen has taken…
The Federal Circuit today issued its formal mandate in Amgen v. Sandoz, as promised in its October 16th order denying the parties’ petitions for rehearing in the case. With the issuance of the formal mandate, the Federal Circuit has officially ordered that its July opinion in the case must now be implemented. Had…
The Federal Circuit has denied the petitions for panel rehearing and for rehearing en banc in Amgen v. Sandoz. The order denying the petitions is available here.
As we reported previously, Amgen and Sandoz filed a joint motion to lift the stay of proceedings on Amgen’s patent infringement claims and Sandoz’s related counterclaims in the U.S. District Court for the Northern District of California. The district court had ordered a stay on the proceedings pending the outcome of…
In their reply briefs, Amgen and Sandoz further sharpened their arguments in opposition to the en banc review sought by the other. Sandoz continued to emphasize that the text of the BPCIA and 35 U.S.C. § 271(e)(2)(c)(ii) support the panel majority’s holding that a biosimilar applicant may “opt out” of…
Amgen and Sandoz have filed responses to each other’s petitions for rehearing en banc in Amgen v. Sandoz. Amgen’s response to Sandoz’s petition is available here, and Sandoz’s response to Amgen’s petition is available here. We will be posting a summary of these responses later today, and will continue to…
Amgen and Sandoz have filed a joint motion to lift the stay of proceedings on Amgen’s patent infringement claims and Sandoz’s related counterclaims in the U.S. District Court for the Northern District of California. The district court had ordered a stay on the proceedings pending the Federal Circuit’s opinion on appeal…
Hospira, Inc., Celltrion Healthcare Co., Ltd., and Celltrion Inc. (jointly) and the Biosimilars Council filed amicus briefs today in support of Sandoz’s petition for rehearing en banc in Amgen v. Sandoz. The briefs are now publicly available and are attached here and here. UPDATE: Mylan Inc. has also filed an amicus…
Following the end of the injunction imposed by the Federal Circuit’s July 21st opinion in Amgen v. Sandoz, Sandoz today launched its biosimilar product Zarxio–the first product to be approved under the BPCIA’s abbreviated approval pathway for biosimilars. Zarxio is a biosimilar product referencing Amgen’s Neupogen (filgrastim) product, and will be sold at…