Coherus announced completion of initial phases of the Biologic Price Competition and Innovation Act patent exchange with Amgen for its pegfilgrastim biosimilar candidate CHS-1701. Coherus reported that it has received a complete response letter from FDA for CHS-1701’s biologic license application (BLA) and it anticipates resubmitting the BLA in the…
In response to Coherus’s motion to stay discovery in Amgen v. Coherus, Amgen filed an answering brief yesterday opposing this motion. Amgen claimed that any delay in the proceedings would “unduly prejudice Amgen and present a clear tactical advantage to Coherus by impeding Amgen’s ability to enforce its patent rights…
Below are some highlights from second quarter earnings reports recently released by biologics and biosimilar companies. Coherus reported that it has cash and cash equivalents of $118.3 million as of June 30, 2017 and that its total revenue for the first half of 2017 was $1.6 million. In response to a question…
In its Q2 2017 Earnings Call last week, Momenta reported that it continues to work towards a first submission for approval of its wholly owned HUMIRA biosimilar, M923, with a possible commercial launch by 2020. Momenta also reported that it is looking for potential collaborators as it further develops M923. In…
Yesterday during Regeneron Pharmaceutical’s Q2 earnings call, Regeneron announced that its Antibody Discovery Agreement with Sanofi will be ending on December 31, 2017 without an extension. Regeneron’s President and Chief Scientific Officer, George D. Yancopoulos, stated that Regeneron and Sanofi will continue their collaboration with respect to drugs discovered and initially developed under…
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…