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…
As we reported in an earlier post, AbbVie filed a Citizen Petition on June 2, 2015 demanding that FDA impose particular labeling requirements on biosimilar applicants. Since then, several entities have submitted comments regarding AbbVie’s petition—some in support and others adamantly opposing—and AbbVie has supplemented its original petition. We’ve summarized those submissions in…
IPR2015-01514 (Amgen Inc.) (U.S. Patent No. 8,916,157) Petitioner: Amgen Inc. Patent: U.S. Patent No. 8,916,157 Patent Title: Formulation of human antibodies for treating TNF-α associated disorders Patent Owner: AbbVie Biotechnology Ltd. IPR2015-01517 (Amgen Inc.) (U.S. Patent No. 8,916,158) Petitioner: Amgen Inc. Patent: U.S. Patent No. 8,916,158 Patent Title: Formulation of human antibodies for…
As discussed in earlier coverage, Amgen has now made good on its intention to seek a preliminary injunction against Apotex. Amgen looks to block Apotex from marketing its Neulasta biosimilar before the expiration of the 180-day pre-marketing notice following FDA approval. Apotex has previously argued that the Federal Circuit’s panel decision…
The Federal Circuit has denied the petitions for panel rehearing and for rehearing en banc in Amgen v. Sandoz. The order denying the petitions is available here.
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…