Biosimilars Month in Review: May 2023

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The biosimilars month in review highlights infliximab biosimilars data presented at Digestive Disease Week (DDW) 2023, California’s proposed plan to produce and market biosimilar insulin which could result in $100 million in annual savings, and new US Food and Drug Administration (FDA) approvals.

FDA Approvals

In May, the adalimumab-adbm autoinjector pen and the high-concentration, citrate-free formulation of the biosimilar adalimumab-aaty, were approved by the FDA. These approvals highlight the continued growth of the biosimilars market and further expand the treatment options for patients living with inflammatory, autoimmune diseases.

FDA Approves Biosimilar Adalimumab-adbm Autoinjector Pen

The adalimumab-adbm (Cyltezo) autoinjector pen was approved by the FDA ahead of the July 1 commercial launch, according to a statement from Boehringer Ingelheim. The drug is an FDA-approved interchangeable biosimilar to adalimumab (Humira) and is used to treat a variety of chronic inflammatory diseases, including rheumatoid arthritis, juvenile idiopathic arthritis, and psoriatic arthritis. The pre-filled pen will be available in 2-, 4-, and 6-pack options.

"The FDA approval of the Cyltezo Pen is great news for patients living with chronic inflammatory diseases who may prefer administering the medication needed to manage their conditions via an autoinjector," said Stephen Pagnotta, executive director and biosimilar commercial lead at Boehringer Ingelheim. "We're excited to be able to offer the Cyltezo Pen as an additional option to patients.”

FDA Approves High-Concentration, Citrate-Free Biosimilar Adalimumab-aaty

The FDA approved adalimumab-aaty (Yuflyma), a high-concentration (100 mg/mL) and citrate-free biosimilar version of adalimumab (Humira), according to a statement released from Celltrion USA.

The approval was based on a comprehensive assortment of preclinical, clinical, and analytical studies which showed the biosimilar was comparable to the reference drug regarding safety, efficacy, immunogenicity, and pharmacokinetics following treatment initiation.

The drug, which is the first high-concentration and citrate-free adalimumab biosimilar to receive European Commission approval in Europe, will be available via a pre-filled syringe as well as an autoinjector to meet patients’ different preferences and needs.

The Latest Infliximab Biosimilars Data

Data on infliximab biosimilars data included a study presented at Digestive Disease Week (DDW) 2023 in which investigators enrolled adolescent and young adult patients to assess a one-time non-medical shift to an infliximab biosimilar. Other data at the conference included a study demonstrating a switch to an infliximab biosimilar was not linked to adverse events when compared with the originator, and an evaluation of switch back rates among patients receiving ABP 710 (infliximab-axxq).

Non-Medical Switch to Infliximab Biosimilar Did Not Impact Remission in Young Patients

“Studies in adults with inflammatory bowel disease (IBD) have demonstrated that a one-time switch from the originator to a biosimilar has not resulted in loss of response, increased side effects, or antibody development,” wrote Ross Maltz, MD, associate professor and pediatric gastroenterologist in the Department of Pediatrics at the Ohio State Wexner Medical Center. “Data describing non-medical switching is limited in adolescents and young adults.”

A retrospective review was conducted to evaluate the clinical outcomes of one-time non-medical switches from the infliximab originator to a biosimilar in young patients with IBD.

Of those who had a full 12 months of follow-up data (n = 33), 91% remained on the biosimilar (n = 30/33). No statically significant differences in erythrocyte sedimentation rate(ESR), C-reactive protein (CRP), tumor necrosis factor inhibitor (TNF) levels, and albumin were observed pre- and post-switch.

Infliximab Biosimilar Not Associated With Adverse Events in IBD

Investigators evaluated the safety of biosimilar switching in a US cohort of veterans with Chron’s disease and ulcerative colitis who received maintenance originator infliximab between 2017 and 2019.

Of the 790 patients included in the analysis, adverse outcomes occurred in 35.6% of patients at 12 months (35.6% in the switch cohort and 35.3% in the non-switch group). No statistically significant differences in infusion reaction, serious reaction, or immunogenicity rates were observed between both groups.

Study Observes Low Switch Back Rates in Infliximab Biosimilar ABP 710

ABP 710 is an FDA-approved drug for the treatment of inflammatory bowel disease (IBD)-related, immune-mediated diseases such as CD and UC.

Patients with IBD who received the infliximab biosimilar ABP 710 (infliximab-axxq) persisted on treatment during a median follow-up period of 295 days. Further, although most patients switched from the originator, the switch back rate back to the reference drug was generally low.

During the study follow-up period, 74.5% of switchers and 51.3% of infliximab-naïve patients remained on ABP 710 treatment without a treatment gap.

California’s Proposed Insulin Biosimilar Plan

California Insulin Biosimilar Plan Could Save $100 Million in Annual Spending

A cross-sectional analysis of California’s strategy to provide its own low-cost and price-transparent biosimilar insulin to in-state patients showed the proposal could lead to an approximate $100 million decrease in health care spending through the state.

“Insurers and pharmacy benefit managers can incentivize patients to switch to lower-cost products through tools such as formulary placement and out-of-pocket costs,” investigators wrote. “However, including state-led insulin products only on formularies for California plans may require administrative changes, such as using a different plan identification for the California portion of nationwide plans.”

Investigators believe the strategy may be applicable across other states and within other fields with high-cost therapies.