State legislators in Nebraska have unanimously approved a biosimilar substitution bill in the first round of debate and plan to advance it through the legislature after revisions.
According to State Senator John Kuehn, who introduced the bill, “LB 481 is a critical piece of legislation for Nebraska to provide guidance for clinicians and dispensers as biosimilar products pass through the FDA approval process.” It would amend the Nebraska Drug Product Selection Act to allow pharmacists to substitute interchangeable biosimilar products in place of branded drugs.
Similar to the biosimilar substitution laws enacted in 28 other states, the proposed addition to Nebraska’s law requires pharmacists to notify patients if they dispense a biosimilar and must notify the prescribing provider of the switch via electronic health records. The text of the law specifies that providers can prevent biosimilar substitution by writing on the prescription that they do not wish the pharmacist to select another drug. Patients and their caregivers may also indicate they want the product written on the prescription with no substitutions, if desired.
To help consumers become more educated about biosimilars, LB 481 also includes a requirement that Nebraska’s Department of Health and Human Services website must publish and update a list of all biological products deemed interchangeable by the FDA.
“Transparent communication between the patient, physician, and pharmacist is the hallmark of high quality patient care,” said Kuehn on his website. “Proactively establishing the communication framework for use of interchangeable biologics is a common sense step for promoting patient understanding of their own health care and communication among all members of the health care team.”
A press release about the proposed legislation included an account from Jackie Newman, whose young daughter has juvenile rheumatoid arthritis (RA). According to Newman, her daughter Zoe struggled with her painful condition before trying a biosimilar drug, which “relieved much of Zoe’s pain and drastically improved her quality of life.”
Newman now hopes that LB 481 will expand access to biosimilars for other patients and families seeking relief. The bill’s passage, she said, “will dramatically affect not only children like Zoe, but also the thousands of Nebraska patients who stand to benefit from the innovative new treatments biosimilars have to offer.”
The proposed legislation has also received support from the Coalition of State Rheumatology Organizations (CSRO), as some biosimilars are used to treat conditions like RA. The group said in a statement that the bill “provides important pathways for access to these unique medications” while ensuring they are used with proper supervision. “CSRO supports the safe introduction of interchangeable biologic drugs into the practice of medicine in Nebraska and urges the passage of LB 481,” it concluded.
The bill was designated a priority by Jim Scheer, the Speaker of the Nebraska legislature. It is currently in the Enrollment & Review stage of the legislative process and will next move to the Final Reading, where a majority vote will determine whether it will proceed to Governor Pete Ricketts to be signed.
For more information on state biosimilar substitution laws as of March 2017, see the infographic here.
Partnering for Biosimilar Security: India's Role in US Health Care Savings, Supply Chain Stability
May 9th 2024As Indian pharmaceutical companies supplied 4 of every 10 prescriptions in the US in 2022, generating $1.3 trillion in health care savings, a new IQVIA report highlights concerns about supply chain risks and advocates for partnerships to bolster biosimilar security and overall supply chain resilience.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
Eye on Pharma: EU Ustekinumab Approval; New Golimumab Data; Evernorth Adds Humira Biosimilar
April 29th 2024The European Union gained a new ustekinumab biosimilar; Alvotech released positive results from a clinical trial evaluating a golimumab biosimilar and the reference products (Simponi and Simponi Aria), and Evernorth announced that it is set to cover an adalimumab biosimilar at zero cost to patients.
AMCP Posters Tackle Interchangeability and Medicaid, Factors Driving Biosimilar Access
April 24th 2024Two posters from the Academy of Managed Care Pharmacy (AMCP) annual meeting explore how an interchangeable insulin glargine biosimilar plays into Medicaid budgets and the top factors driving access to biosimilars.