Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Biosimilars: US FDA Considering ‘Guardrails’ To Prevent Misinformation

Executive Summary

Agency wants to ensure patients ‘aren’t unnecessarily or unfairly scared off or intimidated’ from taking biosimilars, Office of Therapeutic Biologics and Biosimilars' acting policy director Eva Temkin tells the FDA/CMS Summit; Temkin says recent guidance on biosimilar insulins shows agency is trying to be flexible on interchangeability data requirements.


You may also be interested in...



Biosimilar Insulins (Generally) Won't Need Comparative Clinical Immunogenicity Data, US FDA Says

In a move that will likely be welcomed by industry, the US FDA issued draft guidance stating that sponsors will generally not need to conduct comparative clinical immunogenicity studies in developing biosimilar/interchangeable products.

Biosimilar Switching Studies May Not Be Worth Effort For US Interchangeability, Sponsors Say

Payers are driving the selection of reference products or biosimilars, creating an ‘artificial interchangeability’ unlikely to be affected by the actual regulatory designation, industry reps say; former FDA commissioner Scott Gottlieb says misinformation campaigns around biosimilar and interchangeable products may lead to enforcement by the FDA and Federal Trade Commission.

FDA Biosimilars Chief Leah Christl Joining Amgen; Agency Veteran Sarah Yim Takes Her Place

Christl joins Amgen's policy team in Washington, DC. Yim was reviewer for Inflectra and Amjevita biosimilars.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS141310

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel