Innovator drug developer Genentech, maker of the biologic therapies Avastin (bevacizumab) and Rituxan (rituximab), faces challenges from biosimilar developers in the United States and abroad. This week saw developments in cases concerning both molecules in US and Japanese courts of law.
Innovator drug developer Genentech, maker of the biologic therapies Avastin (bevacizumab) and Rituxan (rituximab), faces challenges from biosimilar developers in the United States and abroad. This week saw developments in cases concerning both molecules in US and Japanese courts of law.
Genentech Holds That Amgen Infringed on Avastin Patents With Mvasi
On Thursday, a California federal judge paused Amgen’s lawsuit that sought to invalidate 27 patents covering Genentech’s innovator bevacizumab, Avastin. The judge will await further action in another case, filed by Genentech, in a Delaware district court.
In October 2017, Amgen filed its California lawsuit, seeking a judgment that Amgen’s FDA-approved bevacizumab biosimilar, Mvasi, did not and will not infringe on the 27 patents at issue for Genentech’s Avastin. It also claimed that it had complied with the information exchange process provided for under the Biologics Price Competition and Innovation Act (BPCIA). Amgen argued that not only did Genentech fail to state a claim on which relief can be granted, but it also mischaracterized Amgen’s statements concerning when it may begin marketing Mvasi.
Genentech, for its part, filed a patent infringement lawsuit against Amgen in a Delaware district court, saying that the biosimilar developer did not provide information required by the BPCIA, other than its abbreviated Biologics License Application, to Genentech, and that Amgen refused to negotiate the scope of litigation concerning patent infringement.
Genentech Sues Sandoz and Kyowa Hakko Kirin Over Rituximab
Genentech has also filed suit against Novartis division Sandoz in a Tokyo District Court, according to The Pharma Letter. Genentech has alleged that the biosimilar developer has infringed on 3 of its patents for Rituxan.
Sandoz’s biosimilar (Rixathon, Riximyo) was approved by Japan’s Ministry of Health, Labor and Welfare in September 2017. In January 2016, Sandoz entered into an exclusive license agreement with Kyowa Hakko Kirin for the distribution and promotion of its biosimilar in the Japanese market.
Under the terms of the agreement, Kyowa Hakko Kirin paid Sandoz an up-front fee and subsequent payments for the regulatory filing and approval of the drug, and will take responsibility for all sales, marketing, and promotional activities within Japan.
Challenges and Guidance in Biosimilar Assessment: An ISPOR Report on HTA Agency Approaches
May 14th 2024The ISPOR report highlights the urgent need for clear guidance on when and how to conduct health technology assessments (HTAs) for biosimilars, emphasizing the challenges faced by HTA agencies and the evolving role of HTAs in evaluating biosimilar value.
Biosimilars Policy Roundup for April 2024—Podcast Edition
May 5th 2024On this episode of Not So Different, The Center for Biosimilars® glances back at all the major biosimilar policy updates from April, including 2 FDA approvals, 1 European approval, and several insights into possible policy changes from the Festival of Biologics USA conference.
Cordavis Report Outlines Strategies for Biosimilar Development, Access in the US Health Care Market
May 8th 2024Cordavis, a CVS Healthspire company, released a report detailing the current hurdles faced in developing and commercializing biosimilars in the US and highlighting efforts by the organization to enhance access and affordability for these products.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Cencora Analysis Shows Differences in Payer Coverage Between G-CSF Biosimilars
May 2nd 2024Data from a Cencora study showed some misalignment in payer coverage of granulocyte colony-stimulating factor (G-CSF) biosimilars, highlighting that while filgrastim biosimilars are often favored over the originator, reference pegfilgrastim still dominates over its biosimilars.