Vermont and Connecticut have recently signed laws providing a pathway for and regulations around the substitution of interchangeable biosimilars for the reference biologic product at the pharmacy level.
A number of states have recently been considering legislation around interchangeable biosimilar substitution at the pharmacy level. Vermont and Connecticut are among the 2 latest states to enact such regulation.
On May 30, 2018, Vermont Governor Phil Scott signed bill S.92 into law as Act No. 193. The Act instructs pharmacists to dispense the lowest-price interchangeable biological product to the patient, as well as notify the prescriber of which biological product has been dispensed.
Specifically, within 5 days of the biological product being dispensed, the pharmacist must communicate to the prescriber electronically through either an interoperable electronic medical records system, an electronic prescribing technology, a pharmacy benefit management system, or a pharmacy record.
In Connecticut, Governor Dannel Malloy signed S. Bill No. 197 into law as Public Act No. 18-74 on June 4, 2018. The Act allows a pharmacist to substitute an interchangeable biological product for a prescribed biological product if it provides a cost saving to the patient. In addition, the Act also includes provisions stipulating the notification to the patient purchasing the drug that there may be a cheaper interchangeable biological product available.
The Act also requires the dispensing physician to make an entry documenting the substitution, as well as inform the prescribing practitioner by facsimile, telephone, or electronic transmission of the substitution.
With the implementation of these laws, Vermont and Connecticut have joined 43 other states and Puerto Rico that have authorized legislation around the substitution of interchangeable biosimilars, despite the FDA having not approved such a product to date.
New Hampshire and Alaska are currently considering similar legislation.
Escaping the Void: All Things Biosimilars With Craig & G
May 4th 2025To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."
Eye on Pharma: Interchangeability Labels and Expanded Biosimilar Partnerships
May 29th 2025The FDA designates 2 biosimilars as interchangeable, enhancing access to treatments for inflammatory diseases and multiple sclerosis, while 2 other companies expand their biosimilar partnership to include more products.
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.
What Stands in the Way of Biosimilar Use Across MENA Countries?
May 21st 2025Despite the clear promise of cost savings and expanded access, the path to integrating generics and biosimilars across the Middle East and North Africa (MENA) region is tangled in a web of distrust, inconsistent policies, and deep-rooted cultural preferences for branded drugs.