HR5526-119

What This Bill Does

The Biosimilar Red Tape Elimination Act collapses the separate biosimilar and interchangeable-biosimilar categories. It amends section 351(k) of the Public Health Service Act so a biological product licensed as biosimilar is generally deemed interchangeable with its reference product. Products licensed after the transition date would be interchangeable upon licensure, except where an existing first-interchangeable exclusivity period for the same reference product is still in effect. Products licensed before the transition date would become interchangeable on that date. The bill removes separate application and information requirements for interchangeability, updates related statutory references, and requires FDA to revise, revoke, or update interchangeability guidance within 18 months. It also adjusts pediatric-assessment rules so certain biosimilars are not treated as having a new active ingredient when the relevant pediatric indication is already approved for the reference product and the needed assessment would not require a product strength, dosage form, route, or condition of use outside the biosimilar pathway.

Who Benefits and How

Biosimilar manufacturers benefit because they no longer need a separate FDA interchangeability showing for pharmacist substitution status. Pharmacists dispensing biologics benefit from clearer substitution status when licensed biosimilars are deemed interchangeable. Patients using biologic medicines benefit if broader biosimilar interchangeability increases competition and lowers drug costs. Health insurers and pharmacy benefit managers benefit from easier formulary use of interchangeable biosimilars.

Who Bears the Burden and How

FDA biologics staff must revise or revoke interchangeability guidance and update review practices within 18 months. Reference product manufacturers face more competitive pressure from biosimilars that are automatically deemed interchangeable. Existing first-interchangeable exclusivity holders face a transition rule that protects active exclusivity but removes the separate pathway afterward. State pharmacy regulators must account for the federal change when applying substitution laws tied to interchangeability.

Key Provisions

• Removes the separate interchangeable-biosimilar application pathway.
• Provides that licensed biosimilars are deemed interchangeable with their reference products after transition rules apply.
• Protects existing first-interchangeable exclusivity periods during the transition.
• Requires FDA to update biosimilar interchangeability guidance within 18 months.
• Modifies pediatric-assessment treatment for certain biosimilar products.