Today, AbbVie filed a complaint against Boehringer Ingelheim (BI) in the U.S. District Court for the District of Delaware regarding BI’s aBLA for a biosimilar version of AbbVie’s Humira (adalimumab) product. The complaint alleges infringement of 8 patents: U.S. Patent Nos. 8,926,975; 9,018,361; 9,090,867; 9,096,666; 9,255,143; 9,266,949; 9,272,041; and 9,546,212. According to the…
Last week, Boehringer Ingelheim announced that it had enrolled the first patient into its VOLTAIRE-X interchangeability study. This Phase 3 study will investigate the interchangeability of BI’s adalimumab biosimilar candidate, BI 695501, and Humira® in patients with moderate-to-severe chronic plaque psoriasis. According to BI, results from this study are expected in the…
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…
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…