Newsletter | May 14, 2026

05.14.26 -- Do Changes Signal The End Of Biosimilar Regulatory Redundancy?

INDUSTRY INSIGHTS

A 5-Step Guide To Achieving Your Biosimilar Milestones On Time

As the biologic patent cliff looms, biosimilar developers must strategically plot their approach to development and manufacturing to secure a corner of their market and reach their target patients.

From Fermentation To Vaccination

Non-animal-origin squalene is gaining momentum in vaccine adjuvants. See how fermentation-derived squalene delivers comparable performance, strong stability, and regulatory alignment.

FEATURED EDITORIAL

U.S. Pharma Tariffs And MFN Become Law After April 2 Update

Beginning July 31, 2026, a U.S. pharmaceutical tariff will apply to patented products and their APIs, beginning with large companies. Beroe Inc.'s Mathini Ilancheran breaks down the tariff's impact, explores its risks, and proposes five procurement strategies to addressing them.

FDA's First cGMP Enforcement Action On AI Misuse In Drug Manufacturing

The warning letter, issued to Purolea Cosmetics Lab, describes a manufacturer that used AI agents to generate drug product specifications and more. Here's why the outsourced pharma industry should take note.

Do Changes Signal The End Of Biosimilar Regulatory Redundancy?

First came excitement over the looming patent cliff. Then, FDA and EMA took big swings at what many have called redundant work. Combined, they make a more attractive environment for biosimilar developers.