News

News

FDA Approves Biocon’s Avastin® Biosimilar Jobevne™ (bevacizumab-nwgd)

by Robert S. Schwartz, Ph.D.
April 14, 2025

On April 10, 2025, Biocon announced the FDA approval of Jobevne™ (bevacizumab-nwgd) as the sixth biosimilar of Genentech’s Avastin® (bevacizumab).  Jobevne™’s approval comes five years after its aBLA acceptance was publicly announced and joins Amgen / Allergan’s Mvasi® (bevacizumab-awwb), approved in September 2017, Pfizer’s Zirabev® (bevacizumab-bvzr), approved in June 2019, Amneal / mAbxience’s Alymsys® (bevacizumab-maly), approved in April 2022, Celltrion’s Vegzelma® (bevacizumab-adcd), approved in September 2022, and Bio-Thera’s Avzivi® (bevacizumab-tnjn), approved in December 2023.  There are at least two pending aBLAs for Avastin® biosimilars, Samsung Bioepis’s SB8 and Centus / Fujifilm Kyowa Kirin’s FKB238, both accepted by the FDA in November 2019.  Currently, there are no pending patent disputes related to Avastin® biosimilars.

According to a Q1 2025 Biosimilar Market Dynamics Report from Samsung Bioepis, Avastin® biosimilars have captured approximately 90% market share in the six years since the first launch and have discounts averaging 49% off the reference product’s average sale price (ASP).

Sales of bevacizumab were approximately $2 billion in 2023.

For more information about these and other biosimilars and biosimilar patent proceedings, please visit BiologicsHQ.

 

__________________________________________

The author would like to thank April Breyer Menon for her contributions to this article.

    Methodology

    Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

    Disclaimer

    The individuals who maintain this site work for Venable LLP. The information, comments and links posted on this site do not constitute legal advice. No attorney-client relationship has been or will be formed by any communication(s) to, from or with the site and/or the author. For legal advice, contact an attorney at Venable LLP or an attorney actively practicing in your jurisdiction. Do not send any confidential or privileged information to the author; neither Venable LLP nor the author will assume any liability or responsibility for it. If you send any information, documents or materials to the site, you give permission for the author to include them on or in the site. No information, documents or materials you send to the site will be considered confidential or privileged by Venable LLP or its lawyers. Also, no such information, documents or materials will be returned to you. All decisions relating to the content belong to the author.

    Subscribe for Future Updates

      captcha