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Biosimilar October News Roundup: An Interchangeable Biosimilar Approval and More


The second interchangeable biosimilar approval, estimates of biosimilar savings, and competition for ranibizumab biosimilars characterized the month's developments.

The month of October brought a mixture of payer, regulatory, and clinical news in biosimilars, and these and more stories were covered by The Center for Biosimilars®.

One of the top stories was the approval of interchangeable status for the adalimumab biosimilar Cyltezo. This product was originally approved by the FDA as a biosimilar in 2017. Boehringer Ingelheim has projected a launch date of July 1, 2023.

The Center for Biosimilars® covered multiple poster and speaker presentations at the Academy of Managed Care (AMCP) Nexus 2021 meeting. In surveys presented at the conference, US pharmacists were found to have an insufficient understanding of biosimilars and interchangeability, and patients with immune-mediated disorders were only moderately accepting of these lower-cost-but-equivalent agents.

Also at AMCP, Jeff Casberg, MS, RPh, predicted that “authorized biologics”— manufacturer biosimilar versions of their own originator products—may soon enter the marketplace to compete against biosimilars.

Roche won FDA approval of an implantable device for delivery of ranibizumab, which poses a challenge to biosimilar makers. The implantable (Susvimo) requires refilling every 6 months and delivers a steady flow of ranibizumab to the eye. Biosimilars, on the other hand, must be injected into the eye as often as once a month.

Biocon Biologics reported strengthening biosimilar revenues, which are now one of its profit drivers, although the company has wrestled with FDA concerns about its Malaysia biologics factory. The company said it has established a plan for correcting the problems the regulatory body has identified.

Basaglar has been on the market since 2016, and although it references Lantus, it isn’t technically a biosimilar; but the presence of this drug has had an important effect on the affordability of insulin glargine, according to a recent study. From 2015 to 2020, net prices of Lantus declined by 5.2% per quarter.

It can happen that reference brands end up costing less than biosimilars. Much depends on how aggressive manufacturers are in competing with biosimilars. A specialty pharma report from CoverMyMeds predicted that increasing savings from biosimilar competition could benefit 1.2 million more patients by 2025. The report, however, also charted the rates of prescription abandonment by patients whose medications are priced beyond affordability. At $250 out of pocket, the rate of abandonment is higher than 55%, the report said.

Do varying dosage and infusion intervals for infliximab improve outcomes for patients with rheumatoid arthritis and ankylosing spondylitis? Investigators working on the 5-year RAAS study say the answer is an unequivocal yes. They measured dosage, infusion interval, and combined treatment pattern changes for real-world patients and found the changes reduced disease activity, although survival patterns were not notably different. The agent used in the study was CT-P13.

Lastly, the Biosimilars Forum, a trade association of biosimilar developers and manufacturers, converted biosimilar data from Pacific Research Institute to create a “what if” calculator for biosimilar savings. If biosimilar adoption reached a 75% market share (vs reference products) in each state of the union, the total national savings would be $14.08 billion, the group said. The calculator allows users to look up the respective savings for each state based on a 75% utilization rate.

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