Biosimilar

In this Healio video exclusive, Leonard Calabrese, DO, chief medical editor of Healio Rheumatology, discussed the top items from the February issue, including an exploration of how the placebo effect can be applied in rheumatology.

In this Healio video exclusive, Michael V. Chiorean, MD, explains that physicians can safely and “with confidence” switch patients with inflammatory bowel disease from an originator biologic to a biosimilar at any point during treatment.

The FDA has approved Simlandi as the third interchangeable biosimilar to Humira following a rejection in April 2023 stemming from issues at the developer’s manufacturing facility.

The U.S. Department of Veterans Affairs will replace Humira with the biosimilar Hadlima on its national formulary, according to a press release from Organon, which markets biosimilar.

A lot can change in a year. But has it?

Use of a second anti-tumor necrosis factor agent resulted in early clinical response in nearly 50% of patients with ulcerative colitis and long-term remission in about 30%, with no difference reported between IV and subcutaneous agents.

Celltrion USA has submitted a Biologics License Application to the FDA for its tocilizumab biosimilar candidate CT-P47, according to a press release.

An initiative to switch clinically stable patients from Remicade to a biosimilar significantly increased biosimilar use in rheumatology and gastroenterology clinics within the University of North Carolina health system, according to data.

The FDA’s approval of Zymfentra in fall 2023 offers patients the “flexibility” of a subcutaneous therapy option for moderately to severely active ulcerative colitis and Crohn’s disease, Stephen B. Hanauer, MD, told Healio in an interview.

CVS Caremark, one of the nation’s largest pharmacy benefit managers, will remove Humira from its major national commercial formularies effective April 1 in favor of biosimilar options, according to a press release from the company.