A couple weeks ago, Oregon passed a law that allows pharmacists to automatically substitute a biosimilar for the reference branded biologic. According to this new legislation, before a biosimilar can be automatically substituted, it must be approved by the FDA as an “interchangeable” biosimilar, and the prescriber must not have…
FDA today approved Celltrion’s Inflectra, a biosimilar to Janssen’s Remicade (infliximab). This is the second biosimilar to be approved by FDA under the new BPCIA regime. For more information, see FDA’s press release on the approval, here: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm494227.htm.
On April 1, Sanofi and Regeneron announced positive results in two placebo-controlled Phase 3 studies of dupilumab, a monoclonal antibody under evaluation for the treatment of adult patients with inadequately controlled moderate-to-severe atopic dermatitis. According to Sanofi’s and Regeneron’s press release: “There are no approved systemic therapies in the U.S….
On April 1, the U.S. Patent & Trademark Office published new rules for AIA proceedings before the Patent Trial & Appeal Board, including inter partes reviews (IPRs). IPRs are becoming an important tool for biosimilar manufacturers to challenge patents on biologic drugs (for example, see here, here, and here). Some of the most…
Attorneys for Amgen and Apotex appeared before the Federal Circuit yesterday to argue about whether the notice of commercial marketing provision, 42 U.S.C. § 262(l)(8)(A), is optional when a biosimilar applicant has provided its application and information to the reference product sponsor (RPS) under paragraph (l)(2)(A). The notice of commercial marketing triggers a…
Since the TPP’s signing by twelve Pacific Rim countries this past February, the agreement has been making its way through the “next phase” of its development—ratification through the signatory countries’ “respective domestic processes.” As we’ve covered previously (see our posts here and here), if enacted, the TPP’s intellectual property provisions…
This is an update on the latest activity before the United States Supreme Court in the ongoing dispute between Amgen and Sandoz regarding Sandoz’s biosimilar application for Zarxio® (filgrastim-sndz). Federal Circuit Proceedings As we previously reported, in May last year, a split Federal Circuit panel held that the patent dance…
In December, AbbVie filed a citizen petition on interchangeability. In its citizen petition, AbbVie argued that before a biosimilar can be designated interchangeable, the FDA should: Require interchangeability be established in each condition of use for which the reference product is licensed, regardless of whether the applicant intends to label…
As we posted yesterday, Amgen has filed a brief in opposition to Sandoz’s petition to the Supreme Court for review of the Federal Circuit’s decision in Amgen v. Sandoz. Amgen’s brief is now available here. The Biosimilars Council also filed a brief, as amicus curiae in support of Sandoz’s petition. Their…
We recently posted about Sandoz’s petition to the Supreme Court for review of the Federal Circuit’s decision in Amgen v. Sandoz here. In their opposition brief filed Monday, Amgen argued that delaying the 180-day notice until after approval would confirm that any requested injunction blocking the biosimilar is factually based….