WebJan 22, 2015 · The Biologics Price Competition and Innovation Act: Potential Problems in the Biologic-Drug Regulatory Scheme . By Ryan Timmis * In 2010, Congress passed the Patient Protection and Affordable Care Act, often referred to as “Obamacare.” Though little noticed in the fanfare surrounding this event, Title VII, the Biologic Price Competition … WebThe goal of the BPCI Act is similar, in concept, to that of the Drug Price Competition and Patent Term Restoration Act of 1984 (a.k.a the “Hatch-Waxman Act”) which created abbreviated pathways ...
Federal Register :: Biosimilars: Additional Questions and Answers ...
WebBiologics Price Competition and Innovation Act The Biologics Price Competition and Innovation Act, which is included in the Patient Protection and Affordable Care Act, creates an approval pathway for biosimilar and interchangeable biological products while preserving the incentives that have fueled the development of these medicines. Approval … Web(a) Licensure of biological products as biosimilar or interchangeable.—Section 351 of the Public Health Service Act (42 U.S.C. 262) is amended— (1) in subsection (a)(1)(A), by inserting “under this subsection or subsection (k)” after “biologics license”; and (2) by adding at the end the following: fitbit dress watch
The Biologics Price Competition and Innovation Act 10--A …
WebBackground: The Biologics Price Competition and Innovation Act (BPCIA) of 2009, which included pathways for FDA approval of biosimilar products, was designed to promote more affordable, expanded patient access to biologic therapies. Achieving these BPCIA goals depends on overcoming formidable barriers to biosimilar adoption. Managed care … WebDec 8, 2010 · The Affordable Care Act contains a subtitle called the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) that amends the PHS Act and other statutes to create an abbreviated approval pathway for biological products shown to be highly similar (biosimilar) to, or interchangeable with, an FDA-licensed reference … WebThe Biologics Price Competition and Innovation Act of 2009 (the "BPCIA"), see Pub. L. No. 111-148, §§ 7001-7003, 124 Stat. 119, 804-21, created a new regulatory pathway, 42 U.S.C. § 262(k), by which the FDA could approve a … can food waste be recycled