On November 19, 2015, the European Medicines Agency’s (EMA) Committee for Medicinal products for Human Use (CHMP) recommended the granting of a market authorization for Benepali, a biosimilar intended for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and plaque psoriasis. This is the second biosimilar antibody drug that…
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…
As we have written about extensively, here, here, and here, the Federal Circuit recently interpreted two key provisions of the BPCIA in Amgen v. Sandoz. Three cases currently pending before District Courts raise related issues and each have the potential to reach the Federal Circuit. In this post, we provide…
As we’ve covered previously (here and here), Amgen has moved for a preliminary injunction to prevent Apotex from launching its biosimilar version of Amgen’s Neulasta until at least 180 days after FDA licensure of Apotex’s product. In its reply to Apotex’s opposition to its motion for a preliminary injunction, Amgen reiterates its…
The TPP agreement was reached on October 5, 2015, and the full text of it was released on November 5, 2015. But it hasn’t become law yet in the U.S., and may not for some time. What are the various requirements needed before the TPP can be finalized as law?…
Yesterday, Sandoz announced that the FDA has accepted its Biologics License Application (BLA) under the 351 (k) pathway for its proposed biosimilar to Amgen’s Neulasta® (pegfilgrastim). This is the second of ten proposed regulatory filings Sandoz has promised to make over the next three years (the first of which is…
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…
Yesterday Judge Cohn issued a supplemental scheduling order in Amgen v. Apotex. The hearing for Amgen’s Motion for Preliminary Injunction has been rescheduled for December 3, 2015. Claim construction briefing will occur in December and January, and the claim construction hearing will be held on February 5, 2016. Expert reports…
In the wake of Amgen’s decision to drop Count II from its Complaint, which sought declaratory judgment that Hospira’s failure to provide manufacturing information violates 42 U.S.C. § 262(l)(2)(A), (discussed on the blog here), Hospira has sent a letter to the Court stating that it intends to refile its motion…
On Tuesday, Chris Christie, Governor of New Jersey, signed an automatic substitution bill into law that would allow pharmacists to substitute a biological product that has been determined by FDA to be “interchangeable with” or “therapeutically equivalent to” a prescribed biological product unless the prescriber indicated that there should be…