The FDA has announced a draft guidance, titled “Refuse to File: NDA and BLA Submissions to CDER.” The guidance is intended to clarify the circumstances where the CDER (Center for Drug Evaluation and Research) may refuse to file a submitted NDA or BLA, and it reinforces the importance of submitting…
The FDA granted final approval of Sanofi’s 505(b)(2) application for Admelog yesterday. According to the FDA, Admelog is a follow-on product that, for approval, relied in part on FDA’s finding of safety and effectiveness of Eli Lilly’s Humalog and also relied on Admelog-specific data from two phase 3 clinical trials. The FDA had…
We have been following the Delaware Amgen v. Coherus (pegfilgrastim case). In response to Amgen’s Complaint, Coherus filed a motion to dismiss the entire suit arguing that Amgen’s Complaint failed to state a plausible claim of infringement. According to the case docket, last Thursday, Magistrate Judge Christopher J. Burke issued his Report…
On December 5, 2017, the Federal Circuit heard oral argument in Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Company, 17-1694. Momenta is appealing a PTAB decision upholding the validity of BMS’s U.S. Patent No. 8,476,239 (“the ’239 patent”) which covers BMS’s Orencia® product. One of the issues raised in the appeal is whether Momenta,…
In October, a Federal Circuit panel vacated a permanent injunction (which the Federal Circuit had earlier stayed pending appeal) that would have otherwise prohibited the sale of Sanofi and Regeneron’s Praluent® (alirocumab) product and remanded the appeal to the district court for a new trial on the defendants’ written description…
Below are recent updates in biosimilar-related IPR proceedings: GENERAL BIOLOGICS PATENTS On December 1, 2017, the Board granted institution of four IPRs on Celltrion’s petitions (IPR2017-01373 and IPR2017-01374) and Pfizer’s petitions (IPR2017-01488 and IPR2017-01489 [decisions under seal]) challenging Genentech’s Carter patent, U.S. Patent No. 6,407,213, directed to humanized antibodies. This same patent…
As we previously reported, Janssen and Samsung Bioepis jointly filed a stipulation of voluntary dismissal requesting that the District of New Jersey dismiss with prejudice Janssen’s patent infringement claims against Samsung Bioepis based on Samsung Bioepis’s filing of its aBLA for Renflexis® (infliximab-abda). Samsung Bioepis launched Renflexis®, a biosimilar of Remicade®, in…
On Friday, Biocon and Mylan announced that the European Medicines Agency has accepted applications for their proposed trastuzumab and pegfilgrastim biosimilars. As we previously reported, Biocon had earlier requested withdrawal and resubmission of these applications, which it said was part of the EMA’s procedural requirements linked to the re-inspection of Biocon’s…
Today, the FDA announced that it has approved Mylan’s Ogivri (trastuzumab-dkst) as a biosimilar to Genentech and Roche’s Herceptin (trastuzumab). Ogivri is indicated for adjuvant treatment of breast cancer and treatment of metastatic breast cancer or stomach cancer in patients whose tumors overexpress the HER2 gene. Ogivri is the first biosimilar version…
As we previously reported, Amgen and Hospira both filed motions asking the Court to partially set aside the jury verdict in the Amgen v. Hospira litigation. In its motion, Hospira had asked the Court to set aside the jury verdict as to its accused batches under the § 271(e)(1) safe harbor, and…