Sarfaraz K. Niazi, PhD, a professor, entrepreneur, and biosimilar advocate, took aim at criticisms of the Inflation Reduction Act to 2022 that was passed in the Senate and critiques the argument that the bill should be considered a “price control” measure.
On August 7, the US Senate approved the Inflation Reduction Act of 2022 strictly by political divide line, with the vice president breaking the majority vote.
This act allows Medicare to negotiate prices of 10 drugs first and then expand later. This bill caps seniors’ out-of-pocket spending for prescription drugs at $2000 per year. In addition, 13 million Americans covered under the Affordable Care Act will see their health insurance premiums reduced by $800 on average. Senate Republicans on Sunday blocked a $35 monthly cap on the patient out-of-pocket cost of insulin in the private market, though it stays for Medicare patients.
While everything looks good for patients, a barrage of negative views of the bill has filled the media, hoping to turn it at the House level. Opposing this bill are the Biosimilars Council and its parent Association for Affordable Medicines, both with a charter to reduce the cost of drugs to patients. Craig Burton, Executive Director of Biosimilars Council, said that the "price control" will hurt the industry.
However, there is no mention of price control in the bill; it is price negotiation, and no one is forced to accept it. No change is made in the exclusivity of biological drugs so that it will not hurt big pharma; it will help the adoption of biosimilars as they are in a better position to negotiate.
In a letter to vice president Kamala Harris, I recorded the history of my involvement since meeting the CMS in 2019, when I found them disconnected and disinterested in reducing the cost of Medicare; my suggestion was to allow Medicare to negotiate the pricing that required Congressional approval—we have it now.
Those opposing this bill are misleading the public by calling it "price control." Those responsible for reducing the drug cost, which is 5 times greater for Americans compared to the following country, are influenced by big pharma. Biosimilar Council's position is entirely misleading, failing to fulfill the purpose of their association. It is sad the politics take charge of the humanitarian causes.
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 chariman 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®.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Review Calls for Path to Global Harmonization of Biosimilar Development Regulations
March 17th 2025Global biosimilar regulatory harmonization will be needed to reduce development costs and improve patient access, despite challenges posed by differing national requirements and regulatory frameworks, according to review authors.
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.
From Amjevita to Zarxio: A Decade of US Biosimilar Approvals
March 6th 2025Since the FDA’s groundbreaking approval of Zarxio in 2015, the US biosimilars market has surged to 67 approvals across 18 originators—though the journey has been anything but smooth, with adoption facing hurdles along the way.