comprehensive -WSS

comprehensive

author：hotspot 2025-09-06 01:24:47 - browse：24

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： At least 13 dead in Texas as scorching temps continue
Next article： Removing probiotics from the NICU could threaten preemies' health

leisure time

WSS

Victims of gun violence feel impacts long after bullet wound

6 solutions to address cancer drug shortages and others

What we owe ALS patients — and why one company fell short

Extreme heat events are a public health emergency

The new shift in health care is toward less care

Lawsuit highlights wrinkle for disputes over surprise medical bills

hotspot

comprehensive

entertainment

Medicare details structure of new drug price negotiation program

Medicare solvency divides Republicans at the presidential debate

Medicare details structure of new drug price negotiation program

The United States is paying nearly triple for new Covid vaccines

The cancer drug shortage isn’t new — and neither are the solutions

2023 Nobel Prize in Medicine goes to Karikó and Weissman

After affirmative action ruling, medical educators look to 'holistic review'

IVG is promising — but it won’t replace IVF quite yet

Moonlake's readout produced a cash windfall. Risks remain

FDA approves potent Eli Lilly obesity drug, Zepbound

hotspot

Study: New antibiotic targets gonorrhea as well as last existing drug

Victims of gun violence feel impacts long after bullet wound

European officials brace for rough respiratory virus season

Study points to new risk in gene therapy death of Terry Horgan

More doctors should go into startup world

Extreme heat events are a public health emergency

leisure time

hotspot

Wikipedia

focus