April Breyer Menon, Author at Venable's BiologicsHQ

Biosimilar Launch and Approval Updates – Tyenne® (tocilizumab-aazg), Xlucane™ (ranibizumab), Hercessi™ (trastuzumab-strf)

by April Breyer Menon | May 3, 2024

First Actemra® Biosimilar Launch – Fresenius Kabi’s Tyenne® (tocilizumab-aazg) On April 15, 2024, Fresenius Kabi announced the U.S. launch of Tyenne® (tocilizumab-aazg), the first Actemra® (tocilizumab) biosimilar to launch in the U.S., after receiving FDA approval in...

Amgen and Sandoz Settle Prolia® / Xgeva® Biosimilar Litigation

by April Breyer Menon | Apr 30, 2024

Amgen and Sandoz reached a settlement in Case No. 1:23-cv-02406 (D.N.J.) on April 29 just hours before a New Jersey District Court Judge (Christine O’Hearn) was scheduled to announce her ruling on Amgen’s preliminary injunction against Sandoz’s Jubbonti® / Wyost®...

PTAB Issues Final Written Decisions On Zynteglo® Gene Therapy Patents

by April Breyer Menon | Apr 25, 2024

On April 22, 2024, the PTAB issued Final Written Decisions in two related inter partes reviews, IPR2023-00070 and IPR2023-00074, upholding two patents that cover Zynteglo® (betibeglogene autotemcel), a gene therapy treatment for adult and pediatric beta-thalassemia....

Alvotech and Teva’s Selarsdi™ (ustekinumab-aekn), Biosimilar to Stelara® Approved by FDA

by April Breyer Menon | Apr 23, 2024

According to an April 2024 press release, Alvotech and Teva’s Selarsdi™ (ustekinumab-aekn) was approved by the FDA on April 16 as a biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab). The companies announced in June 2023 that they had...

Ha Kung Wong Discusses Navigating the Patent Thicket: Balancing Innovation, Biosimilar Access in the Biologics Market with The Center for Biosimilars

by April Breyer Menon | Apr 23, 2024

In an interview with the Center for Biosimilars, Venable’s Ha Kung Wong explores the challenges of “patent thickets” in the biologics market, where a complex web of patents can hinder development of more affordable biosimilar drugs. The discussion...

« 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.