Earlier this year, the Center for Medicare and Medicaid Services (CMS) proposed new rules that would regulate payment for biosimilars, creating a single payment category for all biosimilars of the same reference biologic. Under the proposed scheme, Medicare and Medicaid payments for those biosimilars would be based on the average…
As we reported in a previous post, Amgen is the plaintiff in another suit litigating the patent information provisions of the BPCIA, this time against Hospira. Amgen’s complaint alleged that Hospira violated the BPCIA by (1) not providing manufacturing information within 20 days of FDA’s acceptance of Hospira’s biosimilar application for review…
Momenta and Baxalta have announced a global clinical trial to study the safety, efficacy and immunogenicity of M923, a biosimilar to AbbVie’s Humira (adalimumab). The trial is intended to support regulatory filings in both the U.S. and the E.U. with the goal of launching commercially in 2018. Read more here.
As we’ve reported previously, the parties in Amgen v. Apotex have completed the first wave of the BPCIA patent dance and are now litigating the first round of patent infringement claims. In its complaint, Amgen also alleged that Apotex provided Amgen with an “ineffective” Notice of Commercial Marketing pursuant to 42 U.S.C. §…
We recently posted about the PTAB declining to sanction CFAD for filing IPRs. In light of that holding, Erich Spangenberg, owner of nXn Partners, revealed his intention to make publicly available substantially final draft versions of IPR petitions for pharmaceutical patents that he believes are invalid. Spangenberg does not care who…
On October 5, 2015, Apotex filed its answer and counterclaims in the ongoing Amgen v. Apotex Neulasta® (pegfilgrastim) litigation. As we previously reported, Amgen’s complaint alleged that Apotex provided Amgen with an “ineffective” Notice of Commercial Marketing pursuant to 42 U.S.C. § 262(l)(8)(A), because “a subsection (k) applicant may only give…
It was announced this morning that the U.S. has reached an accord on the Trans-Pacific Partnership Agreement (TPP). As we reported in previous posts on this topic, one major point of dispute between parties to the negotiations was the length of the data exclusivity period that member-states would need to…
On September 24, 2015, the Federal Circuit issued an opinion in Shire LLC v. Amneal Pharm., LLC. The opinion may be of interest to readers of this blog for its holding that a company supplying the active pharmaceutical ingredient to abbreviated new drug application (“ANDA”) filers (so that they can file…
Amgen and Allergan announced their biosimilar candidate ABP 215 “met its primary and secondary endpoints” in a Phase 3 study by demonstrating “clinical equivalence in efficacy, and comparable safety and immunogenicity, to bevacizumab.” ABP 215 is a biosimilar of Avastin (bevacizumab), a recombinant immunoglobulin G1 monoclonal antibody, for treatment of…
As we’ve covered in previous posts (here and here), the parties in Janssen v. Celltrion have been supplementing their briefings on whether Celltrion’s notice of commercial marketing, given before FDA approval of its biosimilar application, was legally effective under the BPCIA as interpreted by the Federal Circuit in Amgen v. Sandoz. Janssen has…