Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Countdown To Transition: US FDA Says 91 Drugs Will Become Biologics In March 2020

Executive Summary

A Pink Sheet infographic shows how insulins account for the largest category of transition products, with 27 NDAs that will be "deemed" BLAs in six months; agency is working on a policy to address the transition of authorized generic insulins to regulation under the PHS Act, Office of Therapeutic Biologics And Biosimilars acting policy director Eva Temkin says.

You may also be interested in...



The Last Days Of NDAs: Uncertainties Remain Ahead Of 23 March Move From Drugs To Biologics

Exactly how many NDAs ultimately will make the switch, the impact of pending applications on 'Orange Book' listings, and the ramifications for ‘authorized generics’ are areas of focus as the regulatory transition date looms.

Amgen Sees A Vibrant US Biosimilars Market

Biosimilar executives Leah Christl and Chad Pettit see reasons for optimism in the US market as new launches and sales begin to add up. Amgen’s portfolio is annualizing at $1bn as of the fourth quarter.

Amgen Sees A Vibrant Biosimilars Market As Its Business Pushes Into Blockbuster Territory

Biosimilar executives Leah Christl and Chad Pettit see reasons for optimism in the US market as new launches and sales begin to add up. Amgen’s portfolio is annualizing at $1bn as of the fourth quarter.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS140589

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