Pink Sheet is part of the Business Intelligence Division 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 Pathway Dilemma: When Should Sponsors Pick (k) Before (a)?

Executive Summary

Extrapolation and interchangeability appear to be the linchpins for biosimilar sponsors mulling whether to send applications to the emerging 351(k) pathway or the traditional novel biologics approval system.
Advertisement

Related Content

Sandoz Pushing FDA To Make Biosimilar Interchangeability Decisions
Biosimilar Players Will Be Manufacturers Large And Small, Analyst Predicts
And Now For The Real Biosimilar Opportunity: Antibodies And Complex Biologics
Could Judges Require Independent Experts To Explain Biosimilars?
Could Judges Require Independent Experts To Explain Biosimilars?
FDA “Busy” With Biosimilars; Sponsors Already In Pre-IND Meetings
Biosimilars: FDA Trying Group-Think Negotiating Strategy For User Fee
Waxman Says Biosimilar Pathway Will Push Applicants To BLA
Waxman Says Biosimilar Pathway Will Push Applicants To BLA
FDA Searches For Clinical Trial Middle Ground At Biosimilar Hearing

Topics

Advertisement
UsernamePublicRestriction

Register

PS053415

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