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

Pfizer Wants FDA To Stop Sponsor Promos From Implying Biosimilars Are Inferior

Executive Summary

Citizen petition requests agency guidance that specifies what communications are false and misleading; Pfizer cites a Janssen Remicade brochure and Amgen YouTube video that suggest switching to biosimilars could lead to different outcomes.

You may also be interested in...



Amgen’s Neulasta Ad Indirectly Targeting Biosimilars Draws US FDA Rebuke

Animated banner ad claiming administration of Neulasta with Amgen’s Onpro on-body injector has less risk of febrile neutropenia than administration via prefilled syringe draws untitled letter and a rare press release. FDA says claims could undermine confidence in biosimilar pegfilgrastim products.

FDA And FTC Offer Advice On Biosimilar Barriers

Speakers suggest ways to eliminate barriers to biosimilar uptake, but Janssen pushes back, saying there is need to inform physicians and patients of a biosimilar's interchangeability status. Biosimilar advocates want prescriber incentives, labeling changes, and FDA education on interchangeability.

FDA/FTC's Hot Ticket: Biosimilar Workshop On How To Boost Market, From Education To Lawsuits

Speakers suggest ways to eliminate barriers to biosimilar uptake, but Janssen pushes back, saying there is need to inform physicians and patients of a biosimilar's interchangeability status. Biosimilar advocates want prescriber incentives, labeling changes, and FDA education on interchangeability.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS123741

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