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…
On October 29, 2015, Amgen filed its answer to Apotex’s counterclaims in the Amgen v. Apotex Neulasta® (pegfilgrastim) litigation. As background, 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 effective…
FDA recently proposed a new biosimilar naming convention, whereby the nonproprietary name for a biological product would require a new, random four-letter suffix. The new naming convention is in the spirit of emphasizing that biosimilars, unlike generic drugs, are not replicas of their biologic counterpart. In its response to the…
On September 24, 2015, the United Kingdom’s National Health Service (NHS) released a biosimilars guidance document, available here. In it, the NHS bans automatic substitution of biosimilars, meaning that pharmacists may not switch between biosimilars and reference biologics, or between one biosimilar and another, without the consent of the prescribing…
Last year, Hospira, Inc. (owned by Pfizer, Inc.) submitted an abbreviated Biologics License Application (aBLA) for its proposed biosimilar to Amgen’s Epogen (epoetin alfa). The biosimilar has been available in Europe since 2008 – under the name of Retacrit – for the treatment of anemia associated with chronic renal failure. On its quarterly…
The Federal Circuit today issued its formal mandate in Amgen v. Sandoz, as promised in its October 16th order denying the parties’ petitions for rehearing in the case. With the issuance of the formal mandate, the Federal Circuit has officially ordered that its July opinion in the case must now be implemented. Had…