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…
On November 9, Amgen gave the latest signal of its intention to market a biosimilar to AbbVie’s Humira (adalimumab) by presenting detailed findings from a head-to-head phase III clinical study. The study, presented orally at the 2015 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) annual meeting in…
IPR2016-00172 (Coherus BioSciences Inc.) (U.S. Patent No. 8,889,135) Petitioner: Coherus BioSciences Inc. Patent: U.S. Patent No. 8,889,135 Patent Title: Methods of administering anti-TNF-α antibodies Patent Owner: AbbVie Biotechnology Ltd.
In a decision that could have implications for biosimilar drug manufacturers whose products are used for off-label uses, on October 30, 2015, Texas judge Michael Mery threw out strict liability, implied warranty, and negligence claims brought by plaintiff Robert Burt against Genentech Inc. and Genetech USA, Inc. The complaint alleged…
Last Friday, Oct. 30, Janssen filed a motion for leave to file a brief as amicus curiae in support of Amgen in Amgen v. Apotex. As we’ve covered in previous posts, Janssen is one of the plaintiffs litigating the question of what is required under the BPCIA’s 180-day notice of commercial marketing provision in Janssen…