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

Will 2016 Be The Year of the Biosimilar?

This article was originally published in RPM Report

Executive Summary

The first wave of biosimilars seemed ready to come to market in 2015, but only one product actually made it through FDA. The coming year might be the year when multiple biosimilars enter the US.

You may also be interested in...



India’s Revised Biosimilar Guidelines Ready In A Month

A top Indian government official says revisions to the government’s regulatory guidelines for the development of biosimilars, which could herald the next wave of opportunity for the country's $15bn drug industry, should be ready in a month and will "address ethical questions."

Biosimilar Policy Update: Extrapolation Looks Like Default Approach

As FDA nears the first review deadlines for biosimilar applications, some policy points are coming into sharper focus. Clinical studies for immunogenicity sound like a benchmark requirement, while extrapolation of indications also seems like the agency’s default position.

Medicare Reaffirms Faith In Formulary Review Process Ahead Of Part D Changes

Dramatic transformation in the US Medicare Part D benefit design does not require any changes to CMS’ overall approach to reviewing formulary submissions from private drug plan sponsors, the agency says in its final guidance implementing the design changes for 2025.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS079886

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