Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

GPhA Battles State Biosimilar Bills; 5 Passed, 10 Rejected

Executive Summary

Generic Pharmaceutical Association wants to assure legislation on biologics substitution does not impose more restrictions than required for small molecules; opposes measures pushed by Amgen and Genentech.

You may also be interested in...



Sandoz Biosimilar Strategy For Etanercept: Start Small, But Test Globally

Sandoz has begun a global Phase III trial with its biosimilar version of Amgen's Enbrel (etanercept), targeting psoriasis rather than the more lucrative indication for rheumatoid arthritis, with the aim of winning quicker regulatory approval which can be built on as it gains insights testing the medicine.

FDA Biosimilars Guidances Address Immunogenicity Studies, European Bridge Data, Analytics

The agency’s first three draft guidances on biosimilar product development describe how to characterize biosimilar and reference products and extrapolate data on one condition of use to another. FDA says interchangeability is difficult to determine now and will require a switching study.

Amgen, Watson Aim To Launch First Joint Oncology Biosimilar In U.S. In 2017

The partners’ flexibility allows them, together and separately, to establish solid footholds in a still-evolving field with plenty of potential but also uncertainties.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS055474

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