Biosimilar Regulatory solution center

1. Here's What You Need To Know About The Access Consortium Pathway 11/20/2025

   Five nations are collaborating on a work-sharing program to reduce regulatory duplication in drug development.

2. FDA Draft Guidance On CES Signals More Reliance On Toxicity And PK 11/19/2025

   The technology to measure alternative metrics is vastly improved. Now, FDA joins other regulators in deprioritizing comparative efficacy studies for biosimilars.

3. Maximizing The Value Of An Internal Audit Program In Pharmaceutical Quality Operations 11/18/2025

   A shrinking FDA and rising supply pressures demand stronger risk management and smarter internal audits. Here’s how pharma can truly “see things as they really are.”

4. Phages As A Pharmaceutical: New EMA Guidance On Antimicrobial Drug Development 11/17/2025

   The EMA has now issued a draft guidance on quality aspects of phage therapy medicinal products. Rising antimicrobial resistance has renewed interest in bacteriophages to fight pathogens.

5. Process Validation: Working Toward Harmonization Of Terms Used To Identify Validation Lots 10/31/2025

   The terms “confirmatory" and "conformance" batches are inconsistently used in the industry. Since process validation is essential for maintaining compliance and detecting variability, we must work toward harmonization of the terms to avoid confusion.

6. Pfizer's Accord For A Healthier World Program Challenges Stability Study Norms 10/22/2025

   The company developed a novel approach to address the historic lack of stability testing for underserved parts of the world, near the equator.

7. Takeda Reimagines Biopharma Quality For The Digital Age 10/21/2025

   Artificial intelligence, even in its current form, is especially good at synthesizing large data sets. Here's how one company makes the most of it.

8. Streamline Process Development, Digitize Data, And Maximize Your Investments 10/20/2025

   Discover how AI, digital twins, and automation are transforming biomanufacturing by cutting costs, improving quality, and accelerating timelines for smarter, more efficient production.

9. 100% U.S. Drug Tariffs: Implications For Pharma And Outsourcing 10/17/2025

   Research Manager Mathini Ilancheran explores the effects of U.S. drug tariffs on global supply chains, multinational pharma firms, and critical partners across drug development.

10. What Can The Tech Sector's 'Minimally Viable' Concept Teach Biopharma? 10/9/2025

    Deciding what is good enough to get started can support the mindset of building something without sacrificing quality, functionality, or safety.