Biosimilar
FDA denies Stelara biosimilar application from Alvotech
The FDA has denied a biologics license application from Alvotech for its biosimilar to ustekinumab, citing “certain deficiencies” at the company’s facility in Reykjavik, Iceland, according to the manufacturer.
FDA approves Abrilada as second interchangeable adalimumab biosimilar
The FDA has approved Abrilada as the second interchangeable biosimilar to adalimumab, according to a press release from Pfizer.
FDA grants de novo status to ‘5-minute’ drug monitoring tests for Humira, Remicade in IBD
The FDA has granted de novo clearance to ProciseDx Inc. for its therapeutic drug monitoring tests for Humira and Remicade, as well as their biosimilars, in patients with inflammatory bowel disease, according to a company release.
Boehringer Ingelheim Humira biosimilar available at low wholesale acquisition cost
Adalimumab-adbm injection is now available at a low wholesale acquisition cost, Boehringer Ingelheim announced in a company press release.
Adalimumab biosimilar ‘costs more than double’ Humira’s launch price despite discount
Although the current net price of adalimumab biosimilar Amjevita is lower for commercial health plans than that of the originator, it is nonetheless “more than double” what Humira cost at launch in 2003, according to a research letter.
FDA approves first tocilizumab biosimilar for treatment of rheumatoid arthritis, JIA
The FDA has approved Tofidence as the first tocilizumab biosimilar in the United States for the treatment of rheumatoid arthritis and other conditions, according to a statement from the manufacturer.
The Latest News and Notes, plus Conversation with Julia Haller, MD
Hosts Jim Mazzo and John A. Hovanesian, MD, FACS, chat with Julia Haller, MD, about the latest developments in retina, residency training and more.
Patients with IBD who revert to infliximab after biosimilar more likely to quit treatment
Patients with inflammatory bowel disease who reinitiated infliximab treatment after using a biosimilar had a threefold increased risk for discontinuation over time due to unwanted response, according to research.
VIDEO: Efficacy, safety of biosimilars discussed at ASRS annual meeting
SEATTLE — In this video, Esther M. Bowie, MD, discusses findings presented at the ASRS annual meeting on the efficacy and safety of ranibizumab biosimilars.The study, which evaluated 3,964 patients, was presented by Carl C. Awh, MD, FASRS.
Samsung Bioepis, Sandoz enter commercial agreement for Stelara biosimilar
Samsung Bioepis Co. Ltd. announced in a press release that the company has entered a commercialization agreement with Sandoz for SB17, a proposed biosimilar to Stelara.