Chicago, IL /PRNewswire/ - The US is the only country with two classes of biosimilars; an interchangeable status is awarded to approved biosimilars after extensive switching and alternating testing in patients; this designation is mandated in the Biological Price Competition and Innovation Act (BPCIA), which is part of the Affordable Healthcare Act.1 This dual status has caused much harm in creating confidence in the safety of biosimilars. This news is provided by Novel351k, Inc.
In a press release,2 Senator Lee of Utah announced placing a bill in the Senate to forbid FDA from awarding interchangeable status to biosimilars, acknowledging the contributions of Professor Sarfaraz Niazi, a pioneer of biosimilars, stating:
"Of the bill, Professor Sarfaraz Niazi, who has extensively written and studied biosimilars, said, 'I fully support the Biosimilar Red Tape Elimination Act introduced by Senator Lee to forbid the FDA from requiring additional switching and alternating studies in patients to allow interchangeability. According to the FDA, 'biosimilars have no clinically meaningful difference with their reference product,' so if there is no difference, they should be interchangeable without the extensive and expensive switching and alternating studies in patients. First, such studies can never fail, as statistics teaches us and as the hundreds of such studies reveal. These studies are tantamount to human abuse. Creating two classes of biosimilars has weakened the trust in biosimilars. The amendments suggested in the bill are based on scientific and ethical considerations, and it must be voted in by the Senate.'
Professor Niazi has published extensively and argued that an interchangeable status harms the adoption of biosimilars in the US.3 Removing the interchangeable category will significantly reduce biosimilars' price and better serve the patients in the USA. Professor Niazi anticipates giving testimony to the US Senate to support this bill. He is planning similar actions to remove animal and clinical efficacy testing of biosimilars as superfluous exercises that will save billions of dollars and make biosimilars affordable.
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Professor Niazi is a member of University of Illinois faculty and founder of Novel351k, Inc. (351k.com)
1 TITLE VII—IMPROVING ACCESS TO INNOVATIVE MEDICAL THERAPIES Subtitle A—Biologics Price Competition and Innovation https://www.fda.gov/media/78946/download
2 Senator Lee Press Release. https://www.lee.senate.gov/2022/11/sen-lee-introduces-biosimilar-red-tape-elimination-act
3 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.