April Breyer Menon, Author at Venable's BiologicsHQ

Fresenius Kabi’s Actemra® biosimilar Tyenne® (tocilizumab-aazg) Approved in the U.S.

by April Breyer Menon | Mar 12, 2024

On March 5, 2024, the FDA approved Fresenius Kabi’s Tyenne® (tocilizumab-aazg) as a biosimilar of Chugai, Genentech and Hoffman-La Roche’s Actemra® (tocilizumab). This is the second Actemra® biosimilar to be approved in the U.S., following the approval of Biogen and...

Merck Files Four IPRs Challenging The Johns Hopkins University Pembrolizumab Patents

by April Breyer Menon | Mar 12, 2024

On March 4, 2024, Merck Sharp & Dohme, LLC (“Merck”) filed four IPRs challenging The Johns Hopkins University (“JHU”) patents covering methods of treatment using pembrolizumab, which Merck sells under the trade name Keytruda®. The four IPRs are IPR2024-00622...

Stelara® Biosimilar Updates: Settlement of IPR and FDA Review of Proposed Biosimilar

by April Breyer Menon | Mar 6, 2024

On March 4, 2024, the PTAB granted Biocon and Janssen’s joint motion to terminate IPR2023-01444 due to a settlement reached prior to an institution decision. The parties announced in a press release that their settlement and license agreement allows Biocon to...

First High-Concentration Humira® Interchangeable, Alvotech and Teva’s Simlandi®, Approved in the U.S.

by April Breyer Menon | Feb 29, 2024

On February 23, 2024, the FDA approved Alvotech and Teva’s Simlandi® (adalimumab-ryvk) as biosimilar to and interchangeable with AbbVie’s Humira® (adalimumab). Simlandi® is the tenth Humira® biosimilar to be approved, and the third interchangeable, following...

Ha Kung Wong Discusses Patent Shift Predictions and Legal Landscapes of Biosimilars with The Center for Biosimilars

by April Breyer Menon | Feb 26, 2024

In an interview with the Center for Biosimilars, Venable’s Ha Kung Wong examines proposed patent law changes that could significantly impact the biosimilars sector, including limitations on asserted patents, elimination of interchangeability requirements, and...

« Older Entries

Next Entries »

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.