Here are our picks for the top-five most significant legal developments regarding biosimilars in 2017: 5. In January 2017, the FDA released a draft guidance on biosimilar interchangeability, entitled “Considerations in Demonstrating Interchangeability With a Reference Product.” The guidance provides an overview of scientific considerations for demonstrating the interchangeability of a biosimilar…
We previously reported that on September 12, 2017, the FDA accepted for review Sandoz’s aBLA for a proposed biosimilar of Rituxan® (rituximab), which is indicated for the treatment of certain blood cancers and immunological diseases. Yesterday, Genentech filed a complaint in the District of New Jersey based on Sandoz’s proposed rituximab biosimilar, Rixathon/GP2013. Genentech…
As we previously reported, in Amgen v. Sandoz, which relates to both Sandoz’s filgrastim biosimilar (Zarxio) and its pegfilgrastim biosimilar, Sandoz had filed motions for summary judgment regarding non-infringement of Amgen’s ‘878 patent — the only remaining patent at issue in the case — and damages. Amgen opposed both motions, and…
Earlier today, the Federal Circuit Court of Appeals issued its long-awaited decision in the remand of Amgen v. Sandoz from the U.S. Supreme Court. In that decision, the Federal Circuit held that Amgen’s state law claims, based on the failure to follow procedures of the BPCIA patent dance, “are preempted on both field and…
On December 8, 2017, Sandoz, a division of Novartis, announced data purportedly showing that its pegfilgrastim biosimilar candidate matches the reference biologic, Neulasta® in terms of pharmacokinetics, pharmacodynamics, safety and immunogenicity profiles. The data were presented at the 2017 San Antonio Breast Cancer Symposium that was held December 5-9. As we…
The Federal Circuit today ruled decisively in favor of Sandoz in the long-running battle with Amgen over whether state law can be used to compel a biosimilar applicant to participate in the BPCIA’s “patent dance.” The panel unanimously held that the answer is no, because federal law preempts any such state-law…
Below is our fall update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly updates (Summer 2016, Fall 2016, Midwinter 2017, Spring 2017, Summer 2017).
Here are some updates since our last IPR update: HUMIRA On November 6, 2017, Sandoz filed an IPR Petition challenging AbbVie’s U.S. Patent No. 9,187,559 (IPR2018-00156). The ‘559 patent is directed to a method for treating idiopathic inflammatory bowel disease. RITUXAN On November 6, 2017, the Board denied institution of an IPR on Pfizer’s…
On November 14, 2017, Sandoz announced data from four clinical trials comparing its proposed adalimumab and rituximab biosimilars to their reference drugs, Humira® and Rituxan®. We previously reported that the Sandoz adalimumab biosimilar is currently under EMA review. As we reported here, the Sandoz rituximab biosimilar has been approved by the European Commission…
Below are some highlights from third quarter earnings reports recently released by biologics and biosimilar companies. Johnson & Johnson reported that Remicade (infliximab) sales declined more than 1% in the U.S. and more than 8% worldwide year-over-year. During its earnings call, company executives explained that two-thirds of the decline in sales in Europe…