In a quick follow-up to withdrawing a pivotal guidance on biosimilars on 21 June 2018, after Sarfaraz Niazi, CEO of Pharmaceutical Scientist, Inc., had filed a citizen petition and provided detailed advice on modernizing biosimilars regulatory process to Dr. Janet Woodcock, Head of CDER and FDA Commissioner Dr. Scott Gottlieb, the FDA has just-issued a Biosimilar Action Plan (BAP) that considers most of the recommendations made by Sarfaraz Niazi, including:
- Standardized review templates tailored to regulatory dossier preparation;
- Harmonization of regulatory guidance to create global regulatory dossiers;
- In silico models and simulations to correlate pharmacokinetic and pharmacodynamic responses with clinical performance;
- Increased use of non-U.S.-licensed comparator products to remove bridging studies;
- Additional clarity and flexibility for product developers on analytical approaches to evaluating product structure and function to support a demonstration of biosimilarity, including by publishing revised draft guidance on the use of data analysis methods, including statistical approaches; identifying physical produce quality attributes that are most critical to evaluate;
- Exploring ways to reduce the number of lots required for testing;
- Enhanced education program to allow adoption of biosimilars for naïve patients.
The FDA is also establishing an Office of Therapeutic Biologics and Biosimilars (OTTB) to expedite review process, and to invite modern scientific approaches to demonstrate biosimilarity; FDA is further engaging in a public dialogue through a Part 15 hearing and opening a docket to request additional information from the public on what additional policy steps the FDA should consider as we seek to enhance our biosimilar program.
"This fast action by the FDA is a giant step in assuring faster approval of biosimilars and opens up new possibilities of scientific investigation to support claims of biosimilarity," said Sarfaraz Niazi, who has written the largest number of books and papers on the subject of biosimilars. He has also advised global regulatory authorities on designing their goal-specific guidance on the approval of biosimilars.
Pharmaceutical Scientist, Inc., is a consulting company that works closely with the FDA to assist biosimilar companies in securing faster approval by creating science-based, creative development plans to avoid testing in patients.
