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Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more
Our readers may recall that nine HUMIRA biosimilars have been licensed to launch in July 2023, with Amgen’s AMJEVITA the only one to launch to date....more
As we previously reported, on February 11, 2020, Amgen sued Pfizer and its affiliate Hospira, alleging that their proposed biosimilar of Amgen’s NEULASTA (pegfilgrastim) would infringe U.S. Patent No. 8,273,707 (“the ’707...more
As we start the new year, we look back at the top U.S. biosimilar market developments of 2019. Here are some of our highlights, in no particular order...more
As we previously reported, earlier this year Coherus filed a complaint against Amgen in the District of Delaware alleging infringement of patents claiming “stable aqueous pharmaceutical compositions” comprising adalimumab and...more
On December 6, 2019, the Federal Circuit will hear oral argument in a rituximab-related appeal by Biogen. The appeal stems from a final written decision of the Patent Trial and Appeal Board (PTAB) in an inter partes review...more
Here are some recent developments in U.S. legal proceedings relating to biosimilars: On December 10, 2018, in the Southern District of Florida, Apotex filed a motion to dismiss the patent infringement complaint that Amgen...more
On November 8, 2018, on its quarterly earnings call for Q3 2018 (transcript available here), Coherus BioSciences provided updates regarding its commercial launch plans for its recently approved Udenyca™ (pegfilgrastim-cbqv)...more
As we previously reported, Amgen is appealing the District Court’s decision to dismiss, with prejudice, Amgen’s patent infringement complaint against Coherus regarding its (recently approved) biosimilar of Neulasta®...more
Today, Coherus BioSciences announced that the U.S. FDA has approved Udenyca™ (pegfilgrastim-cbqv), its biosimilar of Amgen’s Neulasta®, for patients with cancer receiving myelosuppressive chemotherapy. Udenyca™, which...more
As we previously reported, currently pending before the Federal Circuit are consolidated appeals from five final written decisions of the Patent Trial and Appeal Board (Board) in inter partes review (IPR) proceedings finding...more
In an update on the Amgen v. Coherus appeal regarding Coherus’s biosimilar application for pegfilgrastim, Amgen filed its opening brief on August 20. Amgen’s statement of the issues are...more
There are presently seven biosimilar-related appeals pending before the Federal Circuit. Two of those appeals, Amgen v. Sandoz (Case No. 18-1551) and Amgen v. Coherus (Case No. 18-1993), are from district court judgments in...more
Below is a rundown of some recent developments in BPCIA litigations concerning biosimilars of Neupogen® (filgrastim) and/or Neulasta® (pegfilgrastim). Amgen v. Adello (filgrastim) - As we previously reported, in March,...more
Over the past several weeks, there have been numerous developments in U.S. patent litigation activity relating to biosimilars of Neupogen® (filgrastim) and Neulasta® (pegfilgrastim). Below is a summary of these developments....more
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...more
We previously posted that Coherus had filed a motion to stay discovery in Amgen v. Coherus (involving pegfilgrastim) pending resolution of Coherus’s motion to dismiss. On September 13, Coherus withdrew its motion to stay. ...more
The PTAB has been a busy place for biologics patents in the past few weeks. Here are some of the highlights...more
Below is our summer update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly updates...more
As we have previously reported, on July 25th, Coherus filed a motion to stay discovery pending the result of its motion to dismiss in its litigation against Amgen regarding pegfilgrastim, and Amgen filed an opposition on...more
Coherus Biosciences filed a petition at the US Patent and Trademark Office last week, seeking to cancel the claims of U.S. Patent 8,163,522 (the ’522 patent), entitled “Human TNF Receptor,” and assigned on its face to...more
In response to Coherus’s motion to stay discovery in Amgen v. Coherus, Amgen filed an answering brief yesterday opposing this motion. Amgen claimed that any delay in the proceedings would “unduly prejudice Amgen and present a...more
Coherus announced completion of initial phases of the Biologic Price Competition and Innovation Act patent exchange with Amgen for its pegfilgrastim biosimilar candidate CHS-1701. Coherus reported that it has received a...more