Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more
On July 10, the Senate unanimously passed the Affordable Prescriptions for Patients Act of 2023 (S.150), which seeks to increase competition and lower drug prices by imposing limits on patent litigation related to biological...more
We recently posted on a new FDA draft guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers,” aimed at providing “answers to commonly asked questions...more
Regeneron filed an eighth BPCIA litigation (Case No. 2:24-cv-08760 (D.N.J.)) related to an EYLEA® (aflibercept) biosimilar, against Sandoz’s Enzeevu™ (aflibercept-abzv). The Complaint alleges infringement of 46 of...more
Welcome to the latest issue of Blockbuster Biologics Review, which covers the status and developments of post-grant challenges and patent litigations implicating blockbuster biologics and legislative proposals related to...more
Recent history of Congress's performance as a legislative body has been, to be kind, mixed, and a great many bills, resolutions, and other activities have appeared to be more for show than to accomplish anything worthwhile. ...more
Recently the Senate passed S.150 entitled the Affordable Prescriptions for Patients Act. Those paying attention might recall that Senator Cornyn (R-TX) introduced this bill (joined by Senator Blumenthal (D-CT) and seven other...more
Venable’s BiologicsHQ Monthly Injection - May 2024...more
Last November, the U.S. Patent and Trademark Office issued Guidance to the Examiner Corps that was disclosed to the public at the March 19, 2024 Biotechnology, Chemical, and Pharmaceutical Partnership Meeting, on resources to...more
The U.S. Food and Drug Administration (FDA) recently released a podcast on biosimilars, featuring Dr. Sarah Yim, director of FDA’s Office of Therapeutic Biologics and Biosimilars (OTBB), that seems to indicate a potential...more
As we previously reported, in May 2023, Amgen filed a BPCIA complaint in the District of New Jersey alleging infringement based on Sandoz’s denosumab biosimilars of Amgen’s PROLIA and XGEVA (“the Sandoz Denosumab...more
As we previously reported, the Judicial Panel on Multidistrict Litigation recently granted Regeneron Pharmaceutical’s (“Regeneron”) motion to establish a multi-district litigation (“MDL”) for its aflibercept BPCIA litigation....more
Hosted by American Conference Institute, the Summit on Biosimilars & Innovator Biologics returns to New York City, on June 20 - 21, 2024. Now in its 15th year, the 2024 conference will dive deep into the latest legal,...more
In this review, we discuss the most important recent developments in the biosimilars space, including new biosimilar approvals and launches, litigation under the Biologics Price Competition and Innovation Act (BPCIA),...more
On March 5, 2024, the FDA approved Sandoz’s Jubbonti® and Wyost® (denosumab-bddz) as the first biosimilars of Amgen’s Prolia® and Xgeva® (denosumab). The launch date for these biosimilars has not been announced as Amgen and...more
On March 5, Sandoz announced that the FDA approved its denosumab biosimilars, WYOST and JUBBONTI, as interchangeable with Amgen’s XGEVA and PROLIA. These are the first and only FDA-approved denosumab biosimilars....more
ACI’s FDA Boot Camp – now in its 42nd iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under the Food and Drug Omnibus Reform Act (FDORA). This...more
As previously reported by Big Molecule Watch, trial in Regeneron’s BPCIA case against Biocon regarding Biocon’s proposed aflibercept biosimilar concluded on June 15, 2023 in the Northern District of West Virginia. The...more
A major new research paper has concluded what many doctors had long believed was true – that patients can be switched between reference (or name brand) biologics and biosimilars with no issues involving the safety profiles or...more
On November 17, 2023, Genentech, Hoffman-La Roche, and Biogen (collectively “plaintiffs”) filed a complaint in the federal district court for the District of New Jersey against Dr. Reddy’s Laboratories and Fresenius Kabi...more
On October 31, 2023, the FDA approved Amgen’s Wezlana™ (ustekinumab-auub) as the first biosimilar and interchangeable of Johnson & Johnson / Janssen’s Stelara® (ustekinumab). In May 2023, Amgen and Janssen settled their...more
Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. Since the enactment of the Biologics Price Competition and Innovation Act...more
As we previously reported, in July 2023 Genentech, Inc., Hoffmann-LaRoche, Inc., and Chugai Pharmaceutical Co., Ltd. (collectively, “Genentech”) filed BPCIA litigation against Biogen MA Inc. and Bio-Thera Solutions,...more
Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the biopharmaceutical arena. Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series...more
ACI’s FDA Boot Camp is back in Boston! This essential training course – now in its 41st iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under...more