Biosimilars Month in Review: October 2024

The biosimilars month in review highlights new ustekinumab (Stelara) biosimilar approvals, new data supporting equivalent safety of etanercept and infliximab biosimilars, and new cost savings with adalimumab biosimilars.

New Approval of Ustekinumab (Stelara) Biosimilars

FDA Approves Ustekinumab (STELARA) Biosimilar for Chronic Inflammatory Diseases The US Food and Drug Administration (FDA) has approved ustekinumab-srlf (IMULDOSA), a biosimilar to ustekinumab (STELARA), for chronic inflammatory conditions including psoriasis, psoriatic arthritis (PsA), Crohn’s disease (CD), and ulcerative colitis (UC).

The biosimilar, from Accord BioPharma, was approved based on clinical data from a comprehensive development program showing that its pharmacokinetics, efficacy, safety, and tolerability were similar to that of STELARA. IMULDOSA was further validated to adhere to the FDA’s current guidelines for biosimilar products.

New Presentation of Ustekinumab Biosimilar Approved for Crohn’s, Ulcerative Colitis The FDA has approved an additional presentation of an ustekinumab biosimilar, ustekinumab-aekn (Selarsdi; Alvotech, Teva), expanding the medication’s label to include the treatment of adults with Crohn disease (CD) and ulcerative colitis (UC).

The new presentation is a 130 mg/26 mL (5 mg/mL) solution in a single-dose vial for intravenous infusion. The new CD and UC indications bring the biosimilar’s list of indications to match that of reference ustekinumab.

New Data Support Safety of Biosimilars

Etanercept, Infliximab Biosimilars Not Linked to Greater Infection Risks

Etanercept and infliximab biosimilars may not put patients at risk of infections any different from their originators, Enbrel and Remicade, respectively, according to new research.

A retrospective cohort analysis of Canadian data from the country’s prescription drug utilization information systems showed that, despite a trend of consumer and prescriber worry over safety outcomes with biologic options, such available products for etanercept and infliximab are not linked to significantly increased risks of infection—a key outcome associated with the autoimmune disease-treating agents.

New Cost Savings for Adalimumab Biosimilar

Blue Shield California Offers Adalimumab Biosimilar for a Quarter of Reference Price Blue Shield California has reached a deal with adalimumab biosimilar manufacturer Fresenius Kabi to offer the drug at a quarter of the price of the market reported net price of reference adalimumab (Humira).

The agreement was reached between Fresenius Kabi, which manufactures adalimumab-aacf (Idacio) and is an operating company of Fresenius, and was facilitated by Evio Pharmacy Solutions. As part of the agreement, Blue Shield California will offer the biosimilar for $525 net price per monthly dose, compared to the market reported net price of Humira at $2,100.