The FDA published two draft guidances for comment this week: “Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease” and “Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research.” The guidance on targeted therapies is intended to provide guidance on…
Fresenius Kabi today announced it has submitted an application seeking marketing authorization for its biosimilar version of Humira® (adalimumab) in the EU. This is Fresenius Kabi’s first biosimilar regulatory filing. Four adalimumab biosi.0milar products have been approved in the EU: Amgen’s AmgevitaTM and Solymbic, Samsung Bioepis’s Imraldi®, and Boehringer Ingelheim’s…
Below are IPR updates from this week. LANTUS On December 13, 2017, the Board instituted two IPRs on Mylan’s petitions (IPR2017-01526 and IPR2017-01528) challenging Sanofi’s U.S. Patent Nos. 7,713,930 and 7,476,652, respectively, both related to insulin glargine. As we have reported, both patents are the subject of litigation pending in the…
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…
Today, the FDA announced that it has approved Pfizer’s Ixifi® (infliximab-qbtx) as a biosimilar to Remicade®. Ixifi® is indicated for the treatment of most of the same conditions as its reference product: Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis (in adult patients), rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis. (Remicade®…
The FDA has announced a draft guidance, titled “Refuse to File: NDA and BLA Submissions to CDER.” The guidance is intended to clarify the circumstances where the CDER (Center for Drug Evaluation and Research) may refuse to file a submitted NDA or BLA, and it reinforces the importance of submitting…
The FDA granted final approval of Sanofi’s 505(b)(2) application for Admelog yesterday. According to the FDA, Admelog is a follow-on product that, for approval, relied in part on FDA’s finding of safety and effectiveness of Eli Lilly’s Humalog and also relied on Admelog-specific data from two phase 3 clinical trials. The FDA had…
We have been following the Delaware Amgen v. Coherus (pegfilgrastim case). In response to Amgen’s Complaint, Coherus filed a motion to dismiss the entire suit arguing that Amgen’s Complaint failed to state a plausible claim of infringement. According to the case docket, last Thursday, Magistrate Judge Christopher J. Burke issued his Report…