Archive: 2026/03

First generics and authorized generics both offer cheaper versions of brand-name drugs, but their timing and strategy differ dramatically. Authorized generics, launched by the original brand company, often enter the market on the same day as the first generic - slashing profits and limiting price drops. This tactic undermines the incentives built into the Hatch-Waxman Act.
Replicate study designs are essential for assessing bioequivalence in highly variable drugs, reducing sample sizes by up to 75% while maintaining statistical rigor. Learn how full and partial designs work, regulatory differences between FDA and EMA, and why they’re now the industry standard.