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.
Budget Impact Analysis of Biosimilar Natalizumab in the US
Projected savings from biosimilar natalizumab were $452,611 over 3 years, driven by decreased drug acquisition costs and a utilization shift from reference to biosimilar natalizumab.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
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.
Hesitancy in MENA Nations to Adopt WHO Biosimilar Guidelines Hinders Market Development
July 17th 2024The World Health Organization’s (WHO) new guidelines for biosimilar approvals aim to save time and money for manufacturers in the Middle East and North Africa (MENA), but hesitancy among nations to adopt the guidelines is stifling market development of biosimilars.
BioRationality: Time to Get Rid of PBMs if Biosimilars Are to Succeed
July 15th 2024Sarfaraz K. Niazi, PhD, discusses the challenges with pharmacy benefit managers (PBMs) that plague the biosimilar industry and new legislation that attempts to reform their practices and encourage biosimilar adoption.