Rethinking Biosimilars
BioRationality: Should mRNA Copies Be Filed as NDAs or Biosimilars?
November 4, 2024
Biosimilars are only intended for therapeutic proteins, and to establish this, the FDA moved them from Center for Biologics Evaluation and Research to Center for Drug Evaluation and Research, yet they are still approved under the biologics license application (BLA) pathway. There was no rationale except the FDA was unsure how biosimilars would emerge. The determining factor was whether a product could be fully characterized by the amino acid sequence and its secondary and tertiary structures. So far, so good. Now comes a challenge for the FDA.
BioRationality: Developer-Led Biosimilar Education Unnecessary, FDA’s Got It Covered
October 21, 2024
Teaching health care professionals and other stakeholders about biosimilars and how they are developed and approved is common among many associations and groups. This practice should end now, as the FDA releases a comprehensive Teaching Resource Guide as a toolkit to educate health care professionals about biologics, mainly focusing on biosimilars and interchangeable biosimilars.
BioRationality—The Evolution of the BPCIA and the Bright Future of Biosimilars in the US
October 7, 2024
The Biologics Price Competition and Innovation Act of 2010 (BPCIA) was approved within the approval for the Affordable Healthcare Act, yet it contained many elements that would slow the entry of biosimilars. Fourteen years later, the BPCIA and guidelines based on the BPCIA have changed significantly, reducing development costs. Here is a brief history of major events and future projections:
