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

Biosimilar Guidances Expected In ‘Near Future,’ But Unnecessary, FDA Says

This article was originally published in The Pink Sheet Daily

Executive Summary

Naming and labeling questions will likely be resolved with agency actions on pending biosimilar applications.

You may also be interested in...



Apotex Biosimilar Goes To FDA, But May Enter Crowded Market

Pegfilgrastim product, a collaboration with the Indian firm Intas, may have to compete with multiple filgrastim products, along with its reference biologic, Amgen’s Neulasta.

Sandoz’s Biosimilar Filing Is Culmination Of Paradigm Shift In FDA Drug Review

FDA clinical reviewers moved from traditional “new drug” review mode to determining the evidence needed to demonstrate a follow-on product is highly similar to the reference biologic, Sandoz exec says, describing firm’s interactions with FDA on its filgrastim 351(k) application.

US FDA Finds Pfizer’s COVID Vaccine For Kids 5-11 Worth The Risk Even In Lowest Incidence Model

Overall benefit still favorable when there could be excess hospitalizations due to vaccine-related myocarditis because of ‘the different clinical implications of hospitalization for COVID-19,’ FDA concludes ahead of the advisory committee.

UsernamePublicRestriction

Register

PS076781

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