Tony Hagen is senior managing editor for The Center for Biosimilars®.
The reference product rights holder contends that Centus has not provided complete information about its manufacturing processes related to FKB238, the proposed biosimilar.
Genentech has filed suit attempting to block the anticipated sale in the United States of a bevacizumab biosimilar by Centus Biotherapeutics, a joint venture between Fujifilm Kyowa Kirin Biologics and AstraZenenca. The reference product is Avastin, which already faces biosimilar competition in the United States. Centus has a biologics license application (BLA) under review with the FDA for the bevacizumab biosimilar candidate FKB238, and the company has filed a notice of intent to commercialize the agent.
Genentech alleges that Centus and its constituent corporate owners and partners failed to disclose sufficient information about the proposed biosimilar to enable Genentech to do a sufficient analysis of potential patent infringements. However, the suit claims potential infringement of at least 10 patents related to the manufacture of bevacizumab reference product.
The suit was filed in the US District Court for the Eastern District of Texas. The US drug candidate was approved for marketing this fall in Europe, under the name of Equidacent.
According to the suit, the FDA accepted the BLA for FKB238 on November 18, 2019. The drug is a genetically engineered antibody that inhibits the growth of blood vessels that promote the development of tumors. Avastin, the reference product, was first approved in 2004 and is currently indicated for colon cancer, lung cancer, glioblastoma, ovarian cancer, and cervical cancer.
Genentech and its parent company, Roche, have much to lose from another bevacizumab biosimilar. Owing to biosimilar competition, Avastin saw US sales erosion of approximately $900 million in the first 9 months of 2020, according to Roche.
The first bevacizumab biosimilar to appear on the US market was Amgen’s Mvasi. This launched in July 2019 and was followed by Pfizer’s Zirabev in January 2020. These 2 biosimilars have gained a 40% share of the US market for bevacizumab, according to Amgen.
Genentech asserts that Centus has unfairly abridged its rights to conduct a review of the biosimilar candidate by having access to the BLA and information about the manufacturing processes involved in making the product. The company asserts that Centus provided only partial information and “only conclusory assertions that the patents identified by Genentech…were invalid.”
Quoting from statute, Genentech declared, “Centus was required to provide Genentech with a ‘detailed statement that describes, on a claim by claim basis, the factural and legal basis of [its] opinion…that [the patents identified by Genentech are] invalid, unenforceable, or will not be infringed by the commercial marketing’ of Centus' FKB238 product.”
Commercial notice of marketing must be issued 180 days before the date of the launch of the product. Centus indicated to Genentech via this notice that it would begin marketing FKB238 as soon as October 21, 2020. Marketing cannot begin, however, unless and until the FDA approves the biosimilar candidate, and Genentech said that Centus has asserted, in recent exchanges, that it has complied with all information requests from Genentech as required under the Biologics Price Competition and Innovation Act (BPCIA), which spells out the biosimilar approval pathway, including the “patent dance” exchange of information concerning potential exclusivity infringements.
“Genentech seeks an order declaring that Centus’ actions are contrary to the BPCIA and that the manufacture, use, offer for sale, sale, and/or importation of Centus’ proposed biologic product infringes Genentech’s intellectual property rights,” Genentech said.