Ustekinumab Biosimilars Approved, Data Support Biosimilar Safety, and Adalimumab Biosimilar Offers Cost Savings
核心洞察
The FDA approved ustekinumab-srlf (IMULDOSA) as a biosimilar to ustekinumab (STELARA) for treating chronic inflammatory conditions, based on comprehensive clinical data demonstrating similar pharmacokinetics, efficacy, safety, and tolerability.
A new presentation of ustekinumab-aekn (Selarsdi) was approved, expanding its label to include the treatment of adults with Crohn's disease and ulcerative colitis (搜索), matching the indications of reference ustekinumab.
Research indicates that etanercept and infliximab biosimilars do not pose a significantly increased risk of infections compared to their originators, Enbrel and Remicade, alleviating concerns about safety outcomes.
The biosimilars landscape continues to evolve with new approvals, safety data, and cost-saving measures. Recent developments include the approval of ustekinumab biosimilars, data supporting the safety of etanercept and infliximab biosimilars, and significant cost savings offered by an adalimumab biosimilar.
Ustekinumab Biosimilar Approvals
The FDA has approved ustekinumab-srlf (IMULDOSA), a biosimilar to ustekinumab (STELARA), for the treatment of chronic inflammatory conditions such as psoriasis (搜索), psoriatic arthritis (搜索) (PsA), Crohn’s disease (搜索) (CD), and ulcerative colitis (搜索) (UC). Accord BioPharma (搜索)'s biosimilar was approved based on a comprehensive development program demonstrating similar pharmacokinetics, efficacy, safety, and tolerability to STELARA. The approval confirms IMULDOSA's adherence to FDA guidelines for biosimilar products.
Furthermore, the FDA approved a new presentation of ustekinumab-aekn (Selarsdi; Alvotech, Teva), expanding its label to include the treatment of adults with Crohn's disease (CD) and ulcerative colitis (搜索) (UC). This new presentation is a 130 mg/26 mL (5 mg/mL) solution in a single-dose vial for intravenous infusion. With these new indications, the biosimilar now matches the reference ustekinumab's list of indications.
Safety Data for Etanercept and Infliximab Biosimilars
New research suggests that etanercept and infliximab biosimilars do not increase the risk of infections compared to their originators, Enbrel and Remicade. A retrospective cohort analysis of Canadian data from prescription drug utilization information systems showed that available biosimilars for etanercept and infliximab are not linked to significantly increased risks of infection, a key outcome associated with these autoimmune disease-treating agents. This data addresses concerns regarding the safety of biosimilar options.
Cost Savings with Adalimumab Biosimilar
Blue Shield California (搜索) has reached an agreement with Fresenius Kabi to offer the adalimumab biosimilar adalimumab-aacf (Idacio) at a quarter of the price of reference adalimumab (Humira). Facilitated by Evio Pharmacy Solutions, the agreement sets the net price of the biosimilar at $525 per monthly dose, compared to Humira's market reported net price of $2,100. This represents a substantial cost-saving opportunity for patients requiring adalimumab treatment.