Biosimilar Regulatory solution center

1. 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.

2. 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.

3. AI Performance Management In Biologic And Drug Development 3/7/2025

   Life cycle maintenance is essential in AI-driven drug development. Regulators recommend continuous updates to AI models to monitor and adjust for data pattern changes.

4. The Patent Cliff Looms – Design Your Biosimilar Approach Accordingly 3/3/2025

   In your pursuit of developing a high-quality biosimilar, think strategically. Consider what type of biologic your team’s expertise can support and which is needed most in your target market.

5. What FDA Draft Guidance Tells Us About In-Process Control Strategies 2/28/2025

   The draft aims to modernize the regulations in 21 CFR 211.110 catching up to progress in the field including advanced manufacturing and analytical technologies.

6. U.S. Biosimilars Surge: Clinical Trials, Regulatory Shifts, And The Path To Dominance 2/28/2025

   Joseph Pategou asks and answers, "Where does the U.S. biosimilar market stand now?"

7. Deciphering FDA's 7-Step Framework For AI-Driven Decision-Making 2/27/2025

   The draft framework, published in January, aims to ensure that AI systems used in drug development are robust, reliable, and aligned with regulatory expectations.

8. Strengthening Shop-Floor QA From The Ground Up 2/24/2025

   Quality is created where and when manufacturing happens, not later through inspection. This approach integrates the QA function into daily production operations.

9. Key Regulatory Considerations For The Next Wave Of Gene Therapies 2/21/2025

   The evolving field of viral vector production, driven by advances in gene and cell therapies, is facing increasing regulatory scrutiny and analytical demands.

10. 10 Ways To Speed Up CMC In Early-Stage Drug Product Development 2/21/2025

    The inherent complexity of living cell-based products, vector-based gene therapies, and highly sensitive analytical methods demands robust change management strategies.