Tag: BPCIA

Medications

15 Jul, 2026 0

FDA Listing for Biosimilars: How They Are Rated and Approved

Explore how the FDA evaluates and lists biosimilars. Learn about the BPCIA pathway, the 'totality of evidence' approach, interchangeability standards, and where to find approval data in the Purple Book.

Medications

10 Jan, 2026 10

Biologic Patent Protection: When Biosimilars Can Enter the U.S. Market

Biologic drugs in the U.S. enjoy 12 years of market exclusivity before biosimilars can enter. This delay, enforced by law and patent strategies, keeps prices high and limits patient access. Here's how the system works-and why it's changing.