Legislation, Regulations & Guidances (US)

Pathway for Biosimilars Act (H.R. 1548): To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes.

Promoting Innovation and Access to Life-Saving Medicine Act (H.R. 1427): To amend the Public Health Service Act to provide for the licensing of biosimilar and biogeneric biological products, and for other purposes.

Promoting Innovation and Access to Life-Saving Medicine Act (S. 726): A bill to amend the Public Health Service Act to provide for the licensing of biosimilar and biogeneric biological products, and for other purposes.