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
UsernamePublicRestriction

Sandoz To Seek Omnitrope Therapeutic Equivalence With Genotropin

Executive Summary

Sandoz plans to submit additional data to FDA to establish therapeutic substitutability for its follow-on human growth hormone product Omnitrope

You may also be interested in...



AB Or Not AB? Barr & Sandoz Ponder The Biogeneric Substitution Question

Generic manufacturers may not want substitutability for follow-on biologics, Barr CEO Bruce Downey said Sept. 19 at the Generic Pharmaceutical Association Annual Policy Conference in Washington, D.C

AB Or Not AB? Barr & Sandoz Ponder The Biogeneric Substitution Question

Generic manufacturers may not want substitutability for follow-on biologics, Barr CEO Bruce Downey said Sept. 19 at the Generic Pharmaceutical Association Annual Policy Conference in Washington, D.C

Pfizer’s Omnitrope Options Include Approval Challenge, Substitutability Fight

Pfizer's response to the approval of Sandoz' Omnitrope could signal the extent to which industry gauges the legality of approving follow-on biologics under the 505(b)(2) pathway

Related Content

UsernamePublicRestriction

Register

MT142313

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