To reduce the cost of development of the approval of biosimilars, the FDA is encouraging the introduction of novel analytical methods to establish biosimilarity, reducing more expensive and time-consuming testing.
CHICAGO, Nov. 22, 2022 /PRNewswire/ -- To reduce the cost of development of the approval of biosimilars, the FDA is encouraging the introduction of novel analytical methods to establish biosimilarity, reducing more expensive and time-consuming testing. Professors Schwendenman of the University of Michigan and Niazi of the University of Illinois have received a $2 Million competitive grant from the FDA to introduce validated novel technologies that focus on understanding how post-translational modifications like glycosylation differences impact efficacy, safety, and immunogenicity; the development of alternative methods of using stressing to assess potential structural differences or to assure biosimilarity. The grant title is: “Systematic Analytical Characterization of Innovator and Biosimilar Products with the Focus on Post-translational Modifications.”
Professor Schwendenman is an expert in biopharmaceuticals, nanomedicine, analytical development, and complex generics and has conducted several analytical similarity studies submitted for regulatory approvals. She is a recipient of several FDA and NIH grants.
Professor Niazi is a biosimilar pioneer, having created the term, holds 100+ US patents in biotechnology and dozens of books; he has secured multiple biosimilar approvals from the FDA. Professor Niazi has argued that animal3 and clinical efficacy tastings of biosimilars4 are redundant, slowing down the adoption of biosimilars.5 He convinced the US Senate to consider removing the interchangeable status of biosimilars.6
Together, they are working to streamline the testing of biosimilars, which will reduce the time and cost to market. Other upcoming research of Professors Schwendeman and Niazi includes room-temperature-stable biologics, nano-delivery of complex and combination biologics, mRNA therapeutics, and AI-driven drug discovery and biosimilarity prediction.
Professors Schwendeman and Niazi invite their scientific colleagues and other stakeholders to present their views that can assist in lowering the cost of biosimilars.
For more information, please contact Niazi at sniazi3@uic.edu and Schwendenman at annaschw@med.umich.edu
Professor Schwendenman is a member of the College of Pharmacy, University of Michigan faculty. Professor Niazi is a member of the College of Pharmacy, University of Illinois faculty and founder of Novel351k, Inc. (351k.com)
Novel351k, Inc released this news.
1 https://pharmacy.umich.edu/people/annaschw
2 https://en.wikipedia.org/wiki/Sarfaraz_K._Niazi
3 Niazi SK. End animal testing for biosimilar approval. Science. 2022 Jul 8;377(6602):162-163. doi: 10.1126/science.add4664. Epub 2022 Jul 7. PMID: 35857557.
4 Niazi S. Scientific Rationale for Waiving Clinical Efficacy Testing of Biosimilars. Drug Des Devel Ther. 2022 Aug 24;16:2803-2815. doi: 10.2147/DDDT.S378813. PMID: 36043044; PMCID: PMC9420434.
5 Niazi SK. No two classes of biosimilars: Urgent advice to the US Congress and the FDA. J Clin Pharm Ther. 2022 Sep;47(9):1352-1361. doi: 10.1111/jcpt.13743. Epub 2022 Jul 22. PMID: 35869625.
6 Professor Sarfaraz Niazi Convinces the US Senate. https://finance.yahoo.com/news/professor-sarfaraz-niazi-convinces-us-140000797.html?fr=sycsrp_catchall
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SOURCE Novel351k, Inc.
