Authors

Alex Keeton serves as the executive director of the Biosimilars Council.

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FDA Draft Guidance on Biosimilars Is a Win for Patients; Now Congress Must Finish the Job

Aaron S. Kesselheim, MD, JD, MPH

Latest:

Biosimilar Interchangeability and Substitution in the US: What Comes Next?

Changing the FDA biosimilar interchangeability standards is a necessary but likely insufficient step to improve biosimilar competition in the US.

Ayaaz Hussain Khan, PhD

Ayaaz Hussain Khan, Global Head – Generics, Navitas Life Sciences

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Navigating Data Integrity for Generic Drug Approvals

Continuous innovation is required in various technological aspects to effectively manage the challenges of vast clinical data.

Edward Li, PharmD, MPH

Latest:

Budget Impact Analysis of Biosimilar Natalizumab in the US

Projected savings from biosimilar natalizumab were $452,611 over 3 years, driven by decreased drug acquisition costs and a utilization shift from reference to biosimilar natalizumab.

Jim Lichauer, PharmD, BCPS, FASHP

Jim Lichauer, PharmD, BCPS, FASHP, is the performance improvement program director, pharmacy, at Vizient.

Latest:

The Promise of Biosimilars Is Within Reach for Health Systems

A collaborative exercise with 16 health care organizations nets millions in savings.

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Common Questions From Patients About Adalimumab Biosimilars

Drs Lio, Botsoglou, and Alexrad discuss the most asked questions and common concerns patients have on adalimumab biosimilars.

Camlyn Masuda, PharmD, BCACP, CDCES

Camlyn Masuda, PharmD, BCACP, CDCES, is an associate specialist of pharmacy practice at the Daniel K. Inouye College of Pharmacy at the University of Hawai’i at Hilo.

Latest:

Common Patient Questions About Insulin Biosimilars Pertain to Classification

Nuances in classification for insulin biosimilars can lead to frequent areas of confusion, according to 2 pharmacists.

Ted Mathias, JD

Ted Mathias focuses on trying patent cases. In the last 2 years, he tried 2 cases to judgment and served as lead counsel in a case involving 33 patents that settled favorably on the eve of trial. Mathias has litigated patent cases and handled successful appeals to the Federal Circuit in the areas of medical devices, pharmaceuticals, mechanical devices, e-commerce and software.

Latest:

Opinion: Purple Book Patent Listings Are Only a First Step

Intellectual property attorneys from Axinn discuss the limitations of the Purple Book patent disclosure requirements and the burden these impose on biosimilar developers.

Mayuri Mathuria, MBA

Mayuri Mathuria, MBA, is a consultant in

Latest:

The Next Frontier: Oncology Biosimilars in 2025 and Beyond

The US oncology biosimilar market has rapidly evolved since its launch in 2017, driven by steep price discounts, payer adoption, and provider confidence, with an upcoming wave of biosimilars targeting blockbuster biologics promising further market growth, cost savings, and broader patient access.

Brooke McCormick

Brooke McCormick is an assistant editor for

Latest:

Dr Prerakkumar Parikh Reacts to FDA Approvals for First Neurology, Tocilizumab Biosimilars

Prerakkumar Parikh, PharmD, director of specialty clinical solutions at Magellan Rx Management, reacts to recent FDA approvals for the first natalizumab and tocilizumab biosimilars.

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