Biosimilar Regulatory solution center

1. Do Changes Signal The End Of Biosimilar Regulatory Redundancy? 4/23/2026

   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.

2. FDA's First cGMP Enforcement Action On AI Misuse In Drug Manufacturing 4/22/2026

   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.

3. U.S. Pharma Tariffs And MFN Become Law After April 2 Update 4/15/2026

   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.

4. FDA's New Flexible CMC Framework For CGT 4/14/2026

   The FDA is rethinking CMC oversight for cell and gene therapies, prioritizing science‑based justification over rigid validation models. Learn how this lifecycle‑focused approach could reduce burden.

5. How To Implement Post-Approval Changes On A Global Level 4/14/2026

   To prepare for inevitable process changes after market authorization, this overview provides critical planning advice for assessing risk and minimizing delays.

6. Building Bulletproof Bioprocesses With Equipment Qualification 3/31/2026

   Consistent equipment performance is critical for compliant biomanufacturing. Learn how lifecycle‑based, risk‑driven qualification strategies can reduce risk and improve efficiency.

7. UK's Decentralized Manufacturing Could Be A Revolution; Mind The Risk 3/20/2026

   Decentralized manufacture will only improve patient outcomes if the pharmaceutical quality system at the control site is strong enough to carry the weight of the network.

8. All The Ways Global Biopharma Still Grapples With Annex 1 3/19/2026

   Biopharma companies can't consistently meet Annex 1 expectations. At the heart of the problems, regulators have shifted the burden of proof to manufacturers.

9. Clearing The Fog On New First Air Visualization Expectations 3/18/2026

   Assessing first air using standard smoke studies is qualitative in nature, and it's difficult to establish clear criteria. Here is how regulator positions are evolving.

10. Industry Innovators: APAC's Sharp Advanced Therapeutics Edge 3/17/2026

    APAC is rapidly advancing its role in the global therapeutics landscape, fueled by faster development models. Learn how this momentum is reshaping expectations for innovation and commercialization.