knowledge -WSS

knowledge

author：focus 2025-09-30 22:05:01 - browse：5

Two people in protective equipment work in a lab. — JUAN MABROMATA/AFP via Getty Images

Biosimilars are no longer a new and untested class of medicines. Today, they provide critical treatment options across multiple therapeutic areas. Since the Biologics Price Competition and Innovation Act of 2009 created a regulatory pathway for biosimilar medicine review in the U.S., 37 biosimilars have come to market offering the potential to increase patient choice and cost savings. And according to the 2023 analysis from IQVIA, biosimilars are expected to generate $181 billion in savings for the U.S. health care system over the next five years.

This progress is due, in part, to thoughtfully considered, scientifically robust regulatory standards, which have instilled confidence among health care providers and patients while protecting safety. As a former associate director of therapeutic biologics at the Food and Drug Administration, I had the privilege of helping create and lead implementation of the regulatory framework for biosimilars. The FDA took great care to apply appropriate scientific rigor to the development and approval standards. While I have since moved to Amgen, my goals have remained focused on biosimilar product quality and efficacy, patient safety, and prescriber confidence.

More than a decade later, collective efforts by biosimilar manufacturers and the FDA are paying off.

Get unlimited access to award-winning journalism and exclusive events.

Subscribe Log In

Previous article： How one medical school became remarkably diverse
Next article： Alzheimer's risk factor APOE4 may be a distinct form of the disease

WSS

FDA advisers vote against ALS treatment from BrainStorm

Medicare drug price negotiation program allowed for now

Four alarming medical procedures we’re glad history forgot

Medicaid, Medicare dual

Scientists uncover potential path to treating deadly childhood tumor

Hundreds died while taking an arthritis drug, but nobody alerted patients

entertainment

knowledge

hotspot

New air purifier tech could be key to improving indoor air quality

Drug companies' payments and gifts affect physicians' prescribing

Tori Bowie and the unacceptable rates of Black maternal death

Readout Newsletter: Biogen, Eisai, Aardvark Therapeutics, etc.

Moonlake's readout produced a cash windfall. Risks remain

Scientific mystery highlights the blind spots in genomics databases

New air purifier tech could be key to improving indoor air quality

Scientists uncover potential path to treating deadly childhood tumor

How to save PrEP access — and even expand it

Health tech startups drop sharply from 2021 highs

hotspot

Ionis has late

Mindstrong's demise and the future of mental health care

Would Medicare drug price negotiations stall in a shutdown?

First Opinion on colorectal cancer screening: letter and response

Insurer loopholes limit power of law against surprise medical bills

Overprescribed: High cost isn't America's only drug problem

knowledge

entertainment

explore

hotspot