House hearing on HB 117: sponsors seek flexibility so state law can track FDA changes on biosimilar interchangeability

Representative Michael Leon introduced HB 117 to the House Committee on Health, Human Services and Elderly Affairs, describing the bill as narrow: it would allow state law to adapt to federal changes if the Food and Drug Administration alters regulatory pathways for designating biosimilars as interchangeable with originator biologics. Leon and other supporters said the goal is to avoid a state statute becoming outdated if the FDA adopts new scientific standards that obviate the historical need for in‑patient switching studies.

Sponsor testimony stressed the potential for cost savings and improved access. Leon described how biosimilars can reduce out‑of‑pocket costs for patients and said the bill is intended to permit pharmacists to substitute therapeutically equivalent products as soon as federal guidance allows. He urged caution about misinformation and "nocebo" effects, noting federal agencies (FDA and FTC) are working to prevent anti‑competitive or misleading statements that create unwarranted fear of biosimilars.

Healthcare and industry witnesses had mixed reactions. The New Hampshire Insurance Department told the committee it supports HB 117, emphasizing competition and lower drug prices when biosimilars enter the market. The New Hampshire Medical Society and practicing OB‑GYNs present said protecting patient access to affordable biologic therapies is critical to preserving the clinical workforce and residency enrollment.

Manufacturers represented by Amgen opposed the bill. Amgen state affairs representative Christopher Kent said the interchangeable designation is an important safeguard and argued that pharmacists substituting one interchangeable for another without prescriber involvement could raise dosing or safety issues in some contexts. He also noted the national pharmacy‑substitution statute enacted in 2018 (pharmacy substitution for interchangeable biosimilars) is already in place in state law and functioning, and that New Hampshire would be an outlier if it further loosened interchangeability criteria before federal action.

Physician testimony emphasized both the science and the clinical benefit: Dr. Michael Leon (pharmacologist/trainer) explained the biologics approval pathway and testified that clinical testing and analytical comparability are the bases for biosimilar approval and that, where approved, biosimilars are not distinguishable clinically from reference products.

Ending: Committee members asked technical questions about FDA timelines, how pharmacist authority would function, and how patients could decline substitution. Sponsors said the bill would not act ahead of FDA guidance but would allow the state to implement federal changes promptly to enable competition and lower costs.