Sarfaraz K. Niazi, PhD

The FDA's new artificial intelligence (AI)-based modeling on characterizing protein aggregation could directly impact the safety assurance of biosimilars and other therapeutic proteins.

Sarfaraz K. Niazi, PhD, explained why Indian manufacturers aren’t bringing biosimilars to the United States and how FDA policies and procedures discourage global companies from pursuing US market entry.

Although a complete response letter (CRL) is not an official rejection letter, it can result in approval delays by listing out shortcomings in an application and giving companies an opportunity to respond. In his latest column, Sarfaraz K. Niazi, PhD, goes over how companies can avoid these approval postponements.

Sarfaraz K. Niazi, PhD, goes over some misconceptions surrounding biosimilar adoption as well as some national efforts to make biosimilar uptake easier and biosimilar development more economically efficient.

Sarfaraz K. Niazi, PhD, explains the FDA's changes to the drug review process, the significance of each change, and the published pieces of work that helped inform the FDA's decisions.

In his column, Sarfaraz K. Niazi, PhD, chronicles the potential for biosimilars referencing some of the biggest cell and gene therapies as well as why companies should begin looking into biosimilar development efforts in this space.

Sarfaraz K. Niazi, PhD, summarizes some of the lessons that the entire biosimilar industry can take away from 2022, including what new legislation and policy changes could mean for future biosimilar development.

Sarfaraz K. Niazi, PhD, breaks down the current status of biosimilar development and makes suggestions for which molecules manufacturers should target next in his newest column installment.

In his newest column, Sarfaraz K. Niazi, PhD, looks into the domestic and international support for removing interchangeability for biosimilars in the United States.

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.

Sarfaraz K. Niazi, PhD, explains the significance of the European Medicines Agency (EMA) declaring that biosimilars are interchangeable with their reference products and calls for the United States to do the same in the first installment of his new monthly column.

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.

Sarfaraz K. Niazi, PhD, a professor and biosimilar advocate, chronicles the current efforts to remove animal testing from application requirements for biosimilars under the Biologics Price Competition and Innovation Act (BPCIA), including recent congressional action.

An expert on biotherapeutics recommends more science be applied to World Health Organization (WHO) biosimilar guideline revisions.

Convinced that he could circumvent the time-consuming process of aging whiskey, Center for Biosimilars® Advisory Board member Sarfaraz K. Niazi, PhD, used a lab process to create "biosimilar" whiskey.

The Center for Biosimilars® Advisory Board member Sarfaraz K. Niazi, PhD, explains an “against the grain” approach to tapping unmet need and revenue potential in biosimilars.

Refinements to the analytical testing of biosimilar candidates to verify similarity were worked into 2019 guidance from the FDA. These changes offer what the author considers a more "rational approach."

Animal toxicology studies still get included with biosimilar approval applications, although there are strong arguments that most of these studies are unnecessary. Sarfaraz K. Niazi, PhD, explains the pros and cons.

Clinical efficacy studies are not always required for biosimilars, and it's possible to resist if the FDA does ask for them. Sarfaraz K. Niazi, PhD, suggests a game plan.

Use of the 351(k) biosimilar approval pathway entails legal challenges, high costs, and potentially higher clinical evidence standards. Sarfaraz K. Niazi, PhD, suggests that using the 351(a) pathway for standalone drugs and copy products may be faster and better. This is part 3 of a series.

The road to production of biosimilar messenger RNA (mRNA) vaccines could be very swift compared with the experience for other biologics. With fewer intellectual property restrictions, small manufacturers could step right in, according to Sarfaraz K. Niazi, PhD.

Sarfaraz K. Niazi, PhD, discusses the regulatory approval of future messenger RNA (mRNA) vaccines, which will likely face fewer patent issues and are easy to replicate.

Sarfaraz K. Niazi, PhD, a member of The Center for Biosimilars® Advisory Board, reports on his citizen petition to the FDA to rationalize testing of biosimilars.

Sarfaraz K. Niazi, PhD, a member of The Center for Biosimilars® Advisory Board, recounts a debate with a young clinician over the reliability of biosimilarity testing.

Biosimilars have come a long way, and their path has mirrored that of generics—fraught with obstacles. Still, a stronger embrace is needed from physicians and payers.

Boehringer Ingelheim's argument hinges on how "strength" of formulation is defined in regulatory language.

The FDA may require comparative clinical efficacy for biosimilar approval, but on top of all the other required and available evidence, these trials add little value, Sarfaraz K. Niazi, PhD, states.

Although devastating in its toll on human life, the coronavirus disease 2019 will likely bring new understanding and technology and leave us better prepared to manage the next health threat of this scope.

Now is the time for the FDA to lead again in revising the biosimilar development guidance by eliminating all animal toxicology studies, and replacing them with larger-species pharmacokinetic (PK) studies, allowing the conduct of human PK studies using novel clinical protocols to combine the PK/pharmacodynamic/immunogenicity testing in a single study, and, where possible, avoid these studies if an in-silico approach can provide the confidence of pharmacologic similarity.