comprehensive -WSS

comprehensive

author：focus 2025-09-28 00:50:12 - browse：22

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： Medical records are filled with copy
Next article： Did the public have the right to know Arthur Ashe had AIDS?

WSS

STAT wants to know your pick for a great summer read or listen

Illumina board agrees to spin off Grail, as divestment plans proceed

Grail is spending more than ever lobbying Congress

Inside the fall of star MIT scientist David Sabatini

A new study asks: Are we harming blood donors by taking blood?

Stopping antidepressants leads to symptoms for 1 in 6 patients

leisure time

comprehensive

hotspot

Medical records are filled with copy

Van's Gluten Free Original Waffles recalled for possible wheat allergen

The Supreme Court will review a ruling striking down a domestic violence federal gun ban

Meta looks to target Twitter with a rival app called Threads

How one medical school became remarkably diverse

Pfizer's Covid pill remains 89% effective in final analysis, company says

23andMe had bad news about my health. I wish a person had delivered it

New case study details death in closely watched Alzhiemer's trial

Medical records are filled with copy

Eli Lilly’s Zepbound improved liver scarring in mid

explore

Connecting traumatic brain injury and domestic violence

Listen: PBM conflicts, RSV vaccines, & the future of flu season

Brain 'hot spot' may explain why African Americans feel greater pain

A new study asks: Are we harming blood donors by taking blood?

Van's Gluten Free Original Waffles recalled for possible wheat allergen

Ukraine, Russia accuse each other of planning to attack Europe's biggest nuclear plant

explore

entertainment

focus

knowledge