Pathway to Biosimilars Act (H.R. 5629)
Recent legislation has been introduced in the United States Congress that is a compromise of two years of debate on an abbreviated approval pathway for Follow-on biologics. The two original bills were House Resolution 1038 and House Resolution 1956. The newly introduced legislation is known as The Pathway for Biosimilars Act, H.R. 5629.
Representative Barton's new legislation requires:
- The biosimilar must present information demonstrating that their product is similar based on analytical studies and clinical studies.
- For the biosimilar to be considered interchangeable with the original product, the Secretary of the FDA must issue guidance advising that it is feasible in the current state of scientific knowledge to make a determination of interchangeability for that class of biologic.
- 12 years of data exclusivity for the original product and an additional 6 months of exclusivity for pediatric biologics so that future innovation in the biologic field continues to make advances and brings new medications to the market.
The following Texas organizations have written to Representative Charles Gonzalez in support fo this legislation:
- Texas Healthcare & Bioscience Institute
- Texans for Advancement of Medical Research
- Texans for Safe and Innovative Medicine
- The Alliance for Medical Research
More information can be found on the website for the Coalition for Safe and Innovative Medicine.