July 23, 2018 PR-M07-18-NI-074
CHICAGO /PRNewswire/ -- 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:
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.
Contact: niazi@pharmsci.com.com; +1-312-297-0000; www.niazi.com; www.pharmsci.com
FDA New Plan: https://tinyurl.com/yc8bjpcs
Citizen Petition: https://tinyurl.com/y9okcwhy
Papers: https://karyobio.com/news/
Nice Insight, established in 2010, is the research division of That’s Nice, A Science Agency, providing data and analysis from proprietary annual surveys, custom primary qualitative and quantitative research as well as extensive secondary research. Current annual surveys include The Nice Insight Contract Development & Manufacturing (CDMO/CMO), Survey The Nice Insight Contract Research - Preclinical and Clinical (CRO) Survey, The Nice Insight Pharmaceutical Equipment Survey, and The Nice Insight Pharmaceutical Excipients Survey.