News

News

Fresenius Kabi and Formycon Announce Approval of Stelara® Biosimilar Otulfi™ in the U.S. and E.U.

by Robert S. Schwartz, Ph.D.
October 1, 2024

On September 27, 2024, the FDA approved a fourth biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab): Fresenius Kabi and Formycon’s Otulfi™ (ustekinumab-aauz).  Fresenius and Formycon announced Oltufi™’s approval in the E.U. on the same day.  Oltufi™’s FDA-approval follows Amgen’s Wezlana™ (ustekinumab-auub), approved as an interchangeable biosimilar in October 2023, Alvotech and Teva’s Selarsdi™ (ustekinumab-aekn), approved in April 2024, and Samsung Bioepis and Sandoz’s Pyzchiva® (ustekinumab-ttwe), approved as interchangeable in June 2024.

According to Fresenius Kabi’s press release, under a settlement agreement with Johnson & Johnson, Otulfi™ can be marketed in the U.S. starting no later than February 22, 2025.  Under their settlement agreements, Wezlana™ can enter the U.S. market no later than January 1, 2025, Selarsdi™ no later than February 21, 2025, and Pyzchiva® no later than February 22, 2025.

There are numerous aBLAs for Stelara® biosimilars awaiting approval by the FDA, including Celltrion’s CT-P43 (accepted in June 2023), Accord BioPharma’s DMB-3115 (accepted in January 2024), Biocon’s Bmab 1200 (announced in February 2024), and Bio-Thera’s BAT2206 (ustekinumab) (accepted in July 2024).

There are no pending patent disputes related to Stelara® biosimilars.

Johnson & Johnson reported Stelara® U.S. sales of $6.97B in 2023.

For more information on these biosimilars and other biosimilar patent disputes, please visit BiologicsHQ.com.

 

_____________________________________________________

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