Sarfaraz K. Niazi, PhD, is an adjunct professor of biopharmaceutical sciences at the University of Illinois and the University of Houston, and founder of biosimilars companies Karyo Biologics and Adello Biologics. He also founded the biosimilar advisory company PharmSci.
BioRationality: Withdrawal of Proposed Terminal Disclaimer Rule Spells Major Setback for Biosimilars
December 10th 2024The United States Patent and Trademark Office (USPTO)’s withdrawal of its proposed terminal disclaimer rule is seen as a setback for biosimilar developers, as it preserves patent prosecution practices that favor originator companies and increases costs for biosimilar competition, according to Sarfaraz K. Niazi, PhD.
BioRationality: Should mRNA Copies Be Filed as NDAs or Biosimilars?
November 4th 2024The article by Sarfaraz K. Niazi, PhD, argues that the FDA’s classification of future copies of messenger RNA (mRNA) products could be reconsidered, suggesting they might be eligible for new drug applications (NDAs) or a hybrid biosimilar category due to their unique characteristics and increasing prevalence.
BioRationality—The Evolution of the BPCIA and the Bright Future of Biosimilars in the US
October 7th 2024The Biologics Price Competition and Innovation Act (BPCIA) of 2010 initially posed significant barriers to biosimilar development, but regulatory reforms over the years have drastically reduced costs and approval times, with further advancements expected by 2025 that will foster competition and drive down prices.
BioRationality—The Missing Rationality in Biosimilar Discussions and the Path Forward
September 23rd 2024The article by Sarfaraz K. Niazi, PhD, critiques the irrationality surrounding biosimilars, suggesting that regulatory changes and cost reductions in manufacturing could make biosimilars as affordable as generic drugs.
BioRationality: FDA Clarification Provides New Indications and Process Change for Biosimilars
September 9th 2024Sarfaraz K. Niazi, PhD, explains the FDA's new guidelines on post-approval changes for biosimilars, emphasizing the processes for reporting modifications, comparability assessments, and the potential for biosimilars to introduce new indications or formulation changes, which could significantly impact their market competitiveness and accessibility.
BioRationality: FDA Opens Up Biosimilar Inquiries on Reddit
August 26th 2024Sarfaraz K. Niazi, PhD, urges stakeholders to engage with the FDA on its Reddit forum—where a representative will answer complex biosimilar questions—encourages clearing misconceptions, and advocates for updates to the Biologics Price Competition and Innovation Act guidelines.
BioRationality: Bill to Remove Double Patenting That Harms Biosimilars Heads to the House
August 12th 2024Sarfaraz K. Niazi, PhD, argues that the S-150 bill, also known as the "Affordable Prescriptions for Patients Act of 2023," aims to reduce drug prices by addressing anti-competitive practices, such as patent thickets and product hopping, which hinder the entry of cheaper biosimilars and generics into the market.
BioRationality: Time to Get Rid of PBMs if Biosimilars Are to Succeed
July 15th 2024Sarfaraz K. Niazi, PhD, discusses the challenges with pharmacy benefit managers (PBMs) that plague the biosimilar industry and new legislation that attempts to reform their practices and encourage biosimilar adoption.
BioRationality: MHRA's Procedure Enables Automatic Registration of Biosimilars Approved Elsewhere
March 18th 2024Sarfaraz K. Niazi, PhD, explains how the new international recognition procedure under the Medicines and Healthcare Products Regulatory Agency (MHRA) could expand biosimilar access within the United Kingdom, in his latest column.
BioRationality: EMA Announces Readiness to Waive Comparative Efficacy Studies of Biosimilars
March 4th 2024Sarfaraz K. Niazi, PhD, takes a look at the European Medicines Agency's (EMA) announcement that it will investigate whether comparative efficacy tests should be needed for a biosimilar to receive regulatory approval.
BioRationality: Bringing the FDA and the USP Together to Revolutionize Biosimilars
February 5th 2024In his latest column, Sarfaraz K. Niazi, PhD, highlights challenges in biosimilar development, emphasizing the crucial role of US Pharmacopeia (USP) and advocating for collaboration and standardized guidelines to expedite cost-effective development without compromising safety or efficacy.
BioRationality: It Takes 4 to Tango—How US Entities Can Make Biosimilars Accessible
January 22nd 2024The FDA, Congress, biologic developers, and associations dedicated to evaluating the US biopharmaceutical space will need to work together to overcome challenges to biosimilar accessibility, says Sarfaraz K. Niazi, PhD, in his new column.
BioRationality: An Analysis of the Future of Biosimilars Through the Eyes of History
January 8th 2024Sarafraz K. Niazi, PhD, previews the new year and his hopes for the end of clinical efficacy testing for biosimilar approvals using examples from history of other scientific concepts that took time to gain traction.
BioRationality: In FDA We Trust—A Commentary on FDA Efforts to Educate Biosimilar Stakeholders
December 18th 2023Sarfaraz K. Niazi, PhD, offers his perspective on FDA biosimilar education efforts and the role these efforts and stakeholder perspectives play in uplifting—or undermining—biosimilar adoption.
BioRationality: FDA Launches a New Opportunity to Remove Redundant Trials of Biosimilars
November 6th 2023The FDA introduced a plan to improve clinical trials, including a provision to possibly eliminate clinical efficacy testing for biologic products, which evidence has suggested may not be necessary, according to Sarfaraz K. Niazi, PhD.
BioRationality—A DMF Route to Biosimilars: CDMOs Can Make Biosimilars Accessible and Affordable
October 16th 2023Sarfaraz K. Niazi, PhD, chronicles how drug master files (DMF) can be used in the biosimilar approval process and the role contract development and manufacturing organizations (CDMOs) can play in improving biosimilar accessibility.
BioRationality: Calling on Developers to Help Address Remaining Biosimilar Issues
October 3rd 2023Sarfaraz K. Niazi, PhD, summarized the citizen petitions he's filed to the FDA as well as changes he believes are needed to propel the biosimilar industry into the future, including calling on biosimilar manufacturers to help.