Home / Policies & Legislation / Genentech and Amgen settle biosimilar disputes

Genentech and Amgen settle biosimilar disputes Posted 31/07/2020

Genentech has reached a settlement agreement with Amgen over its biosimilars of Herceptin (trastuzumab) and Avastin (bevacizumab). All claims have been dismissed, allowing Amgen to continue marketing the biosimilars.

The settlement relates to trastuzumab, which is marketed by Genentech as Herceptin, and bevacizumab, marketed by Genentech as Avastin.

Trastuzumab (Herceptin) is a monoclonal antibody that interferes with the human epidermal growth factor receptor 2 (HER2)/neu receptor. In some cancers, notably certain types of breast cancer, HER2 is overexpressed, and causes cancer cells to reproduce uncontrollably. Trastuzumab is therefore used to treat certain breast cancers. It was approved by the US Food and Drug Administration (FDA) in 1998. Genentech’s patent on the drug expired in 2019 in the US allowing biosimilar versions to be developed. Amgen’s biosimilar trastuzumab-anns, sold as Kanjinti, was approved by FDA in June 2019 [1].

Bevacizumab (Avastin) is a humanized monoclonal antibody. It inhibits angiogenesis (the formation of new blood vessels) by blocking the action of vascular endothelial growth factor A (VEGF-A). Bevacizumab can therefore slow the growth of new blood vessels in tumours and is used to treat various cancers, including colorectal, lung, breast, glioblastoma, kidney and ovarian. It first received approval in the US in 2004. In 2017, FDA approved Amgen’s biosimilar version of bevacizumab-awwb, sold as Mvasi [2].

In 2017, Genentech claimed Amgen was violating the Biologics Price Competition and Innovation Act (BPCI Act) with Mvasi (bevacizumab biosimilar), which was soon dismissed. However, in March 2019, Genentech filed a second patent infringement action and attempted to prevent the launch of Mvasi, arguing that the Supplemental Biologics License Application (sBLA) filed by Amgen required them to give new notice of marketing (meaning Amgen would have to wait an extra 180 days before launching the biosimilar).

In July 2019, the district court denied Genentech’s attempts to delay Amgen’s launch of the products on the US market and Mvasi was launched.

Genentech subsequently filed an appeal and emergency motion requesting that Amgen stops selling Mvasi during the appeal. The emergency motion was denied, but the Federal Circuit heard the Appeal in June 2020.

The Federal Circuit on 6 July 2020 confirmed the decision that Amgen’s sBLAs were not new applications that required new notices. One day later, Genentech’s remaining patent infringement cases were dismissed after the parties reached a settlement agreement and voluntarily dismissed all claims.

In a notice to the Federal Circuit, Genentech said they will ‘not petition for any further review of this Court’s decision’.

This is welcome news for Amgen, particularly in combination with the announcement that UnitedHealthcare, the largest insurer in the US, will preferentially cover their anticancer biosimilars [3].

Related articles
Amgen explains the steps of manufacturing a biosimilar

Scientific evidence in development of trastuzumab biosimilar ABP 980

Biosimilars approved in the US

References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves trastuzumab biosimilar Kanjinti [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 31]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-trastuzumab-biosimilar-Kanjinti
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves bevacizumab biosimilar Mvasi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 31]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-bevacizumab-biosimilar-Mvasi
3. GaBI Online - Generics and Biosimilars Initiative. UnitedHealthcare to preferentially cover Amgen’s anticancer biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 31]. Available from: www.gabionline.net/Biosimilars/General/UnitedHealthcare-to-preferentially-cover-Amgen-s-anticancer-biosimilars

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2020 Pro Pharma Communications International. All Rights Reserved.

Source: United States District Court for the District of Delaware; United States Court of Appeals for the Federal Circuit

Comments (0)