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

Poor Biosimilarity Practices, Impurities and New Technologies Debated At European Pharmacopoeia Event

Executive Summary

Some regulators are wrongly using monographs rather than a biosimilarity exercise to show comparability of a biosimilar with its reference product, it was suggested at the European Pharmacopoiea’s latest conference. Also discussed were issues such as how to align the PhEur with the new ICH guideline on elemental impurities, and how advances in technology are being dealt with.

Advertisement

Related Content

Topics

Related Companies

Advertisement
UsernamePublicRestriction

Register

PS119267

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