Minnesota legislators introduce what could possibly become the first law to curtail payers' rights to determine which biologics patients have access to.
Legislators in Minnesota have introduced a bill that would broaden access to biosimilars by requiring health plans and pharmacy benefit managers (PBMs) to cover all versions of biological agents, including biosimilars. The bill is a response to payer policies that sometimes narrow choices of biosimilars and reference products and may force providers and patients to use agents that are more costly than other versions of the same biologics.
“The change would give all patients access to the most affordable and effective version of their medication without compromising safety standards,” Representative Jennifer Schultz (D, Duluth) and Senator Carla Nelson (R, Rochester) said in a statement announcing the bill (SF 990). Schultz said the draft legislation was developed in consultation with research scientists at Essentia Health and Mayo Clinic.
“Biosimilar medications are just as safe and effective as their brand counterparts,” said Eric Tichy, vice chair of Mayo Clinic Pharmacy Supply Solutions. “They are also the most powerful tool we have to control the cost of prescription drugs. Facilitating provider prescribing of biosimilar products for patients supports high-quality care and reduces delays and red tape while also managing the high costs of medication."
According to the language of the bill, PBMs and health plans would not be permitted to prefer or require the use of reference biologics, biosimilars to reference products, or biologics deemed “interchangeable” to reference biologics. If a PBM or health carrier offers coverage of a reference product or biosimilar, it must also cover all versions of that same drug, including reference and biosimilars.
Also under the bill, the Minnesota commissioner of health would be required to track the legislation’s effect on net prices for different payers of biological products, interchangeable biological products, and biosimilar products.
JD Supra, the legal news website, stated that the bill if enacted would produce the first law of this kind. The bill’s supporters have chosen January 1, 2022 as the proposed go-live date.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Biosimilar Approvals Streamlined With Advanced Statistics Amidst Differing Regulatory Requirements
February 25th 2025The FDA and European Medicines Agency (EMA) mandate high similarity between biosimilars and reference products, but their regulatory processes differ, especially with multiple reference products.
Biosimilars Gastroenterology Roundup for November 2024—Podcast Edition
December 1st 2024On this episode of Not So Different, we discuss market changes in the adalimumab space; calls for PBM transparency and biosimilar access reforms grew; new data for biosimilars in gastroenterology conditions; and all the takeaways from this year's Global Biosimilars Week.
Resolution of Injection Site Reactions After Switching to Adalimumab Biosimilar
February 22nd 2025A 15-year-old girl with ulcerative colitis who developed injection site reactions to the adalimumab reference product was successfully switched to the biosimilar LBAL without recurrence of symptoms, demonstrating the safety and effectiveness of switching for medical reasons, likely due to an allergic reaction to an excipient in the originator.