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

Biosimilar Clinical Trials Face Enrollment Challenges

Executive Summary

Education for investigators and patients about the biosimilar development process, including what’s already known about a product being studied, could help trial recruitment, FDA, industry and patient reps say.

You may also be interested in...



Pfizer Sets Inflectra Launch Date; J&J Plans To Fight Back

Pfizer commits to “late November” launch for its biosimilar version of infliximab, partnered with Celltrion, which will be the second biosimilar to reach the US market. Remicade innovator Janssen considers it an “at risk” launch and will continue patent litigation, as well as commercial tactics to protect its market.

Biosimilar Advisory Committee Reviews: Necessity Or Nuisance?

FDA panelists' confusion over biosimilarity and overwhelming approval endorsements following glowing agency reviews suggest the meetings may not be having much impact on FDA deliberations; however, agency sees an opportunity to learn from what its external experts don't understand about biosimilars.

Clinical Trial Diversity Would Benefit From Regulatory, Financial Incentives, Experts Say

Access to expedited regulatory pathways, marketing exclusivity and tax credits in exchange for enrolling and retaining diverse clinical trial populations could provide a ‘carrot’ to the ‘stick’ in US FDA guidance and legislative proposals; attorneys Sarah Thompson Schick and Winston Kirton also call for a re-examination of concerns about remuneration for trial participants.

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS119341

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