Section 1: What Biosimilar Cost-Effectiveness Actually Measures The Misread Metric Most coverage of biosimilars collapses cost-effectiveness into a single question: […]

Somewhere in a regulatory affairs department right now, a development team is arguing about whether to run a comparative clinical

There is a certain type of pharmaceutical executive who still thinks of patent searching as something lawyers do—a back-office function

Generic drug approval is, at its core, a race with rules. The company that reads the rules fastest and most

Biosimilar-to-Biosimilar Switching: The Complete IP, Clinical, and Market Playbook For pharma IP teams, portfolio managers, R&D leads, and institutional investors

The 55% figure should stop every pharma IP team in its tracks. That is the share of new small-molecule drugs

Generic drug development has never been a solo endeavor, but the industry has spent the last decade pretending otherwise. Companies

The average generic drug program takes 3 to 4 years from target identification to FDA approval. For most companies, that

Strategic Patent Barriers and Market Exclusivity in the Pharmaceutical Industry Pharmaceutical companies use patent portfolios to prevent generic and biosimilar