comprehensive -WSS

comprehensive

author：focus 2025-10-02 00:40:25 - browse：135

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： Walensky prepares to leave CDC — and Congress — behind
Next article： In surprise move, FDA calls for advisory committee on Lilly's Alzheimer's drug

focus

WSS

Headspace, Meta partner to launch VR meditation app for Quest

Bacterial infection may be ‘key event’ in endometriosis, study says

Connecting traumatic brain injury and domestic violence

Make 'food is medicine' a key part of White House nutrition meeting

PhRMA sues HHS over Medicare drug price negotiation

Novo Nordisk gets FDA approval to tout heart benefits of Wegovy

entertainment

comprehensive

entertainment

Guidelines to prevent youth baseball injuries need more muscle

Did the public have the right to know Arthur Ashe had AIDS?

What does generative AI mean for health care? We asked experts

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

How to save PrEP access — and even expand it

First medicine developed to treat MASH expected to be approved soon

At least 13 dead in Texas as scorching temps continue

Readout Newsletter: Amylyx, Alto Neuro, and Eli Lilly for the Oscars

FDA approval of Sarepta Duchenne genetic therapy gives me hope

Why is France rioting? What to know about the fatal police shooting of Nahel M

hotspot

Amylyx ALS drug failure raises questions and concerns

Sen. Paul opposes bill to ban Chinese biotechs

How to bring more disabled researchers into academia

Duchenne patients, backed by ‘dark money’ group, to debate drug prices

Why is France rioting? What to know about the fatal police shooting of Nahel M

Why is France rioting? What to know about the fatal police shooting of Nahel M

entertainment

focus

explore

Wikipedia