Yesterday, two groups announced the submission of applications seeking FDA approval of biosimilars of Herceptin® (trastuzumab), which is indicated for the treatment of HER2-positive early breast cancer, adjuvant breast cancer, metastatic breast cancer and metastatic gastric cancer. First, Celltrion and Teva announced that the FDA has accepted for review a BLA…
Novartis recently released its Q2 2017 financials, which included updates on various biosimilar products in its subsidiary Sandoz’s pipeline. Pegfligrastim As we previously reported last July, the FDA last year issued a complete response letter (CRL) rejecting Sandoz’s aBLA for LA-EP2006, a proposed biosimilar of Neulasta® (pegfilgrastim). Sandoz subsequently indicated…
The Board granted Hospira a mixed result in its numerous challenges to Genentech’s patents directed to different aspects of Genentech’s trastuzumab product: The Board instituted IPR of U.S. Patent No. 7,371,379 (IPR2017-00805), U.S. Patent No. 6,627,196 (IPR2017-00804), and U.S. Patent No. 7,892,549 (IPR2017-00737). The Board denied institution of IPR of…
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…
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…
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…