Sanofi-Aventis has filed a petition for IPR of Immunex Corporation’s U.S. Patent 8,679,487, directed to isolated human antibodies that compete with a reference antibody for binding to human interleukin-4 (IL-4) receptor. The proceeding has been assigned the number IPR2017-01879. The ‘487 patent is also at issue in district court litigation regarding Sanofi-Aventis and Regeneron’s…
Earlier this week Coherus filed a motion to stay the BPICA litigation brought by Amgen in the District of Delaware, arguing that in light of the FDA’s complete response letter delaying the launch of Coherus’ pegfilgrastim biosimilar product, a stay of discovery is appropriate until the Court considers Coherus’ motion to…
The White House released a statement of administration policy on July 12 in response to the House of Representatives passing H.R. 2430, a bill that would reauthorize the FDA’s user fee programs, including FDA’s biosimilar user fees. The White House statement calls for “Congress to provide for 100 percent user…
As we previously reported, following the Supreme Court’s decision in Sandoz v. Amgen, Sandoz requested a remand to the District Court to answer the two questions that the Supreme Court had remanded to the Federal Circuit, i.e. (1) whether an injunction is available under state law; and (2) whether such a…
We previously reported, Amgen filed a BPCIA suit against Coherus Biosciences, Inc., relating to its aBLA for its pegfilgrastim (Neulasta®) biosimilar. In response, Coherus filed a motion to dismiss the suit arguing that Amgen’s complaint failed to state a plausible claim of infringement. On June 12, 2017, we also reported that Coherus…
Earlier this month, the House of Representatives passed H.R. 2430: FDA Reauthorization Act of 2017 (FDARA) by voice vote. The FDARA seeks, among other things, to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar…
Today, the District of Delaware reassigned the AbbVie v. Amgen (adalimumab) litigation from retiring Senior Judge Sue L. Robinson to a visiting judge, Judge Mitchell S. Goldberg of the Eastern District of Pennsylvania. Judge Goldberg is one of four visiting judges from the Eastern District of Pennsylvania to whom the…
There has been some recent activity regarding proposed biosimilars to Roche’s Avastin (bevacizumab). Avastin is indicated for the treatment of various types of cancers, including colorectal, lung, and kidney cancer. The Korea Herald is reporting that the Korean Ministry of Food and Drug Safety has approved Celltrion to start Phase…
Merck & Co. and Samsung Bioepis announced today the U.S. launch of Renflexis (infliximab), a biosimilar of Janssen’s Remicade. Renflexis was approved on April 21 by the FDA for all eligible indications. Renflexis will be priced at a 35% discount to the current list price of Remicade (i.e., 65% of…
Sandoz has filed a petition for inter partes review of AbbVie’s U.S. Patent No. 8,802,100 (IPR2017-01823), which claims stable formulations of an anti-TNFα antibody identified in the petition as Humira® (adalimumab). Sandoz also filed a petition for inter partes review of AbbVie’s U.S. Patent No. 9,512,216 (IPR2017-01824), which claims a…