Biologics

Janssen Sues Amgen Over Stelara Biosimilar Plans

Janssen has filed a patent infringement suit in Delaware federal court against Amgen and its plans to seek FDA approval and market a biosimilar copy of Janssen’s blockbuster Stelara (ustekinumab), indicated for treating plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.

Earlier this month, Amgen provided Janssen notice that the biosimilar will be marketed in 180 days (5/6/2023) or immediately once FDA approves the product. “If Amgen carries through with its stated plan, it will infringe at least two Janssen patents that cover Stelara,” Janssen says in its complaint. “Specifically, Amgen’s launch of ABP 654 will infringe at least U.S. Patent No. 6,902,734 (the ’734 patent) covering ustekinumab (the active compound in Stelara), and U.S. Patent No. 10,961,307 (the ’307 patent) covering methods of treating ulcerative colitis with this medicine.”

Janssen’s complaint asks the court for a declaratory judgment of infringement, and to preliminarily and permanently enjoin Amgen from infringing the two patents.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome