Sarfaraz K. Niazi, PhD

March 14, 2023

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.

March 13, 2023

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.

February 27, 2023

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.

February 13, 2023

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.

January 30, 2023

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.

January 16, 2023

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.

January 04, 2023

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.

December 20, 2022

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.

December 13, 2022

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

November 07, 2022

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.