Biosimilar Regulatory solution center

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

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 What FDA Draft Guidance Tells Us About In-Process Control Strategies 2/28/2025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

  8. 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?"

  9. 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.

  10. 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.