Biosimilar Regulatory solution center

1. FDA RIFs Might Delay Your Review — Here Are Tips For Mitigating 4/24/2025

   Mounting concerns that FDA reviewers could start missing PDUFA deadlines have put many on edge. The moment calls for defensive and offensive strategies.

2. ICH Revises Q1 Guideline, Advancing Stability Testing Standards 4/24/2025

   In April 2025, the International Council for Harmonisation (ICH) released draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades.

3. Navigating Tariffs: Implications And Strategies For Pharmaceuticals Manufacturers 4/17/2025

   The U.S. tariffs on trading partners bring a whole new set of challenges, but there are tactics and strategies companies can deploy to help offset the cost and operational impacts. 

4. How AI Is A Game-Changer For Auditing Compliance And Efficiency 4/9/2025

   In the life sciences, audits have long been bogged down by repetitive tasks. AI is changing the way auditors operate, making compliance more seamless than ever.

5. AI Model Cards Make Function And Risk Easier To Understand 3/31/2025

   AI doesn’t follow predefined logic like traditional software. Here's a tool, including a downloadable template, to answer critical compliance questions quickly.

6. Amgen's Deep Learning Approach To Vial Inspection 3/31/2025

   The company is testing how artificial intelligence can help bring down the number of false rejections caused by factors like glare on the glass or bubbles in the vial.

7. Indian Biosimilar Companies Are Poised To Succeed In The Global Market 3/31/2025

   For Indian biosimilar developers looking to capitalize on the upcoming patent cliff, it is vital to play to your strengths and identify strategies for breaking into competitive regulatory markets.

8. A 5-Step Guide To Achieving Your Biosimilar Milestones On Time 3/24/2025

   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.

9. Do Patient Needs Define Biologic Product Specifications? 3/14/2025

   Enhanced product understanding acknowledges the technology advancements of the last 25 years and substantially more complex drug modalities.

10. Trends In FDA FY 2024 Inspection-Based Warning Letters 3/7/2025

    Of the 190 warning letters that the FDA issued to drug and biopharma manufacturers in fiscal year 2024, this article provides a deep dive on trends pertinent to the 111 inspection-based letters. You may be surprised at some of them.