Sarfaraz K. Niazi, PhD, dived into the benefits of the FDA's recently announced Biosimilar Regulatory Science Program, which is expected to help progress biosimilar development and simplify evaluations for interchangeability status.
Recently, the FDA unveiled a significant effort to streamline the approval of biosimilars. For the first time, the new website highlights how the development of biosimilar products can be advanced and how the interchangeable product evaluation can be simplified and made more practical.
The FDA has made a significant shift in its priorities, as explained below:
I am looking forward to significant changes in the Biologics Price Competition and Innovation Act, but what the FDA has disclosed today should incentivize developers to present novel ideas that will reduce the cost and time to market—an essential paradigm shift needed to make biosimilars affordable. Great News!
Author Bio
Sarfaraz K. Niazi, PhD, is an adjunct professor of biopharmaceutical Sciences at the College of Pharmacy at the University of Illinois at Chicago and a patent law practitioner. Additionally, he is the founder and executive chairman at Pharmaceutical Scientist, Inc, the executive chairman of Karyo Biologics, and the founder of Adello Biologics, which was acquired by Kashiv Biosciences in 2019. Niazi also serves on the advisory board for The Center for Biosimilars®.
Link to Dr. Niazi’s last column: https://www.centerforbiosimilars.com/view/biorationality-a-dr-sarfaraz-niazi-column-the-ema-declares-biosimilars-interchangeable
References
[1]McKoy JM, Stonecash RE, Cournoyer D, et al. Epoetin-associated pure red cell aplasia: Past, present, and future considerations. Transfusion. 2008;48:1754-1762. doi:10.1111/j.1537-2995.2008.01749.x
[2]Boven K, Knight J, Bader F, Rossert J, Eckardt KU, Casadevall N. Epoetin-associated pure red cell aplasia in patients with chronic kidney disease: solving the mystery. Nephrol Dial Transplant. 2005;20S:33-40. doi:10.1093/ndt/gfh1072
[3]Niazi SK. Biosimilars: A futuristic fast-to-market advice to developers. 2021:149-155. doi:10.1080/14712598.2022.2020241
[4] Niazi SK. Molecular biosimilarity-an AI-driven paradigm shift. Int J Mol Sci. 2022;23(18):10690. doi:10.3390/ijms231810690
[5] Niazi S. Scientific rationale for waiving clinical efficacy testing of biosimilars. Drug Des Devel Ther. 2022;16:2803-2815. doi: 10.2147/DDDT.S378813
Strengthening the Supply Chain: Key Insights From FDA Commissioner Robert Califf
October 25th 2024At the GRx+Biosims conference, FDA Commissioner Robert Califf, MD, stressed the urgent need for data transparency in the global supply chain and the role of collaboration and artificial intelligence in ensuring the resilience of biosimilar and generic drug production.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
Calling for Unified Biosimilar Standards, Stronger Education at GRx+Biosims
October 23rd 2024At the GRx+Biosims conference, a fireside chat highlighted the need to streamline biosimilar development and strengthen industry collaboration, with Sarah Yim, MD, of the FDA, emphasizing education's key role in building trust and adoption.
GRx+Biosims: Panelists Discuss Regulatory Shifts in Biosimilar Interchangeability
October 22nd 2024At the GRx+Biosims 2024 conference, panelists explored challenges and progress in biosimilar interchangeability regulations in the US, discussing the FDA's new draft guidance, the removal of switching study requirements, and the need for more education to reduce misinformation and improve biosimilar uptake.