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

US FDA Moves To Codify Size-Based Threshold For Drugs To Be Deemed Biologics

Executive Summary

Agency proposes to define by regulation which proteins previously approved as drugs will be deemed licensed biologics, and therefore potentially subject to biosimilars competition. Industry has opposed the size-based thresholds, preferring a structure-based approach.

You may also be interested in...



Mylan And Biocon's Insulin May Get US Reprieve

Bill addresses ‘dead zone’ for pending applications for protein products transitioning to biologic status; generic and brand industries each win in different legislative provisions: inclusion of the CREATES Act, and a revised definition for ‘biologics’ that includes chemically synthesized polypeptides.

Mylan/Biocon’s Insulin Glargine Would Get A Respite Under US Budget Legislation

Bill addresses ‘dead zone’ for pending applications for protein products transitioning to biologic status; generic and brand industries each win in different legislative provisions: inclusion of the CREATES Act, and a revised definition for ‘biologics’ that includes chemically synthesized polypeptides.

Insulin Application Reviews Would Continue After March 2020 Under Senate Bill

Bill would change US FDA's approach to handling follow-on applications submitted under Section 505 once products become "deemed" as biologics 23 March 2020, and could amend a provision in the Senate HELP Committee's health care bill, which aligns with FDA policy.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS124411

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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