Press
Big Pharma's Exit From Biosimilars May Be Imminent
Biosimilar developers are targeting blockbuster “Big Pharma” biologic originator companies. Roche and AbbVie, two companies most susceptible to biosimilar erosion, have vocalized a need for stringent regulatory frameworks — calling for appropriate data, individualized labels, and unique identification for all biotherapeutics — while attempting to rebuff competition by reformulating their products and beefing up both their pipelines and intellectual property (IP).
Scientist Invented A New Pathway To Approve Biosimilars, And The FDA Is Listening
In an extraordinary move, the FDA has withdrawn the draft guidance, “Statistical Approaches to Evaluate Analytical Similarity,” after receiving public comments and one citizen petition (FDA-2018-P-1876). The goal of the guidance was to provide an action plan for evaluation of similarity between proposed biosimilars and the original products.
Forbes: The Most Interesting Man Revolutionizing the Health World
Dr.Niazi wrote his first world-renowned book at the age of 26. On weekends he recites love poems (ghazals) on Voice of America. He casually – and humbly – references his more than 70 patents that range from aging wine to chewing gum to bioreactors to air scrubbing systems at his infamous Chicago wine parties.
Impact of Proposed Changes to FDA Approach to Biosimilars
Since 2007, the EMA has approved 31 biosimilar products1 and refused or withdrawn around five. The FDA, however, since the enactment of the Biologics Price Competition and Innovation Act (BPCIA) in 2009,2 has licensed six products under PHS 351(k) of the Public Health Service (PHS) Act; approved one product under 505 (b)(2) of the Federal Food, Drug, and Cosmetic (FD&C) Act; and sent out four Complete Response Letters (CRLs) to 351(k) Biologics License Applications (BLAs),3 including two applications each for pegfilgrastim and erythropoietin alfa (Table 1).
Sarfraz K. Niazi Biotech Pharma Summit: Conference Series › Speaker › Sarfaraz K. Niazi
Sarfaraz K. Niazi (1), Adjunct Professor of Biopharmaceutical Sciences, University of Illinois College of Pharmacy, University of Houston and several other academic institutions, is the founder of Karyo Biologics (www.karyobio.com), Adello Biologics (www.adellobio.com) and Pharmaceutical Scientist, LLC (www.pharmsci.com).
Forbes: Scientist Invented a New Pathway to Approve Biosimilars, and the FDA Is Listening
In an extraordinary move, the FDA has withdrawn the draft guidance, “Statistical Approaches to Evaluate Analytical Similarity,” after receiving public comments and one citizen petition (FDA-2018-P-1876). The goal of the guidance was to provide an action plan for evaluation of similarity between proposed biosimilars and the original products.
Keynote Speaker:
13th International Conference on
Biosimilars and Biologics
FDA Withdraws Its Pivotal Biosimilar Products Testing Guideline
CHICAGO, July 2, 2018 /PRNewswire/ — In an unprecedented move on 21 June 2018, the FDA withdrew the draft guidance, “Statistical Approaches to Evaluate Analytical Similarity,” issued in September 2017, after receiving public comments and the only citizen petition (FDA-2018-P-1876) filed by Sarfaraz K. Niazi, Adj. Professor, the University of Illinois and the founder of Pharmaceutical Scientist, Inc, on 14 May 2018, in his individual capacity.
Bioprocess International Editorial January-February: From the Editor
Happy New Year! This is our first combined January–February issue, but it should give you plenty of reading material to compensate for the absence of a January issue. There are some new approaches at work for us this year that bring new opportunities for both end-user and supplier authors, as well as offering us additional options for more timely publication of high-priority information.
4th International Conference and Exhibition on Biologics and Biosimilars
Sarfaraz K. Niazi, Ph.D., a leading authority on today’s biologic drug industry. Founder and Chairman of TheraProteins (TPI), a pure play biosimilar company located in Chicago, he is leveraging his diverse background and experiences to revolutionize the way biologics are made with the goal of enabling greater access to high quality, life-changing biosimilars.
Citizen Petition Asks FDA to Withdraw Contentious Biologic Naming Guidance
Earlier this month, the FDA released updated draft guidance on the naming of biologics, biosimilars, and interchangeable biosimilars. The guidance holds that newly approved biologics, biosimilars, and interchangeable products will be assigned 4-letter suffixes, devoid of meaning, but it explains that the FDA no longer intends to require already approved products, including transition products, have such suffixes. The guidance caused deep concern among some proponents of biosimilars, and one stakeholder has now filed a citizen petition with the FDA in which he asks that the guidance be withdrawn.
The FDA Biosimilar Action Plan: Making Biologics More Accessible
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.
Finalizing FDA Guidance on Biosimilars—Expediting Approvals and Acceptance
Biosimilar drugs have suffered slow entrance and acceptance rates in the US market, due not only to common misperceptions among the public but also US Food and Drug Administration (FDA) licensing laws. This review offers nine major recommendations for the FDA to simplify how biosimilars are licensed and thus make biosimilars more accessible to American citizens.
FDA Withdraws Its Pivotal Biosimilar Products Testing Guideline
In an unprecedented move, the US FDA withdrew its guidelines on the approval of biosimilar products, a multi billion dollar marketplace, after Niazi filed a citizen petition identifying the flaws in the scientific strategies of the guideline. This change will allow faster entry of biosimilars to the market and make them more accessible.
A Biosimilar Delayed is a Biosimilar Denied: Dr. Niazi to Present Reasons Why Biosimilars Fail
. Invited presentation at the Regulatory and Development Strategies Biosimilars Markets Access and Commercialization Strategies Summit, Boston September 18-19, The Westin Boston Waterfront.[1] Biosimilar Market Access and Commercialization Strategies Summit provides detailed presentations, intensive case studies and collaborative panel discussions relevant to many fields including biosimilars.
Dr. Niazi Invited by FDA as a Speaker and Panelist
The American Statistical Association Biopharmaceutical Section Regulatory-Industry Statistics Workshop was originally a meeting for the FDA statisticians that later expanded to include all statisticians interested in statistical practices for all areas regulated by the FDA. This year over 800 people are expected to attend this workshop on Sep. 25-27, 2017 in Marriott Wardman Park, Washington D.C.
FDA Opens Portal for Novel Dissolution Testing in Response to Dr. Niazi's Citizen Petition
In a significant move, the US Food and Drug Administration (FDA) is asking for public comments on bioequivalence testing of generic drugs, specifically novel dissolution methods, to allow biowaivers for all types of drugs.
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