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

Insulin Biosimilars: US FDA Hears Wide Range Of Views From Small Set Of Sponsors

Executive Summary

US FDA heard a predictably wide range of advice on the appropriate standards for approving biosimilar and interchangeable insulin during a public hearing on the topic. What is surprising is how few sponsors decided to speak out.

You may also be interested in...



Interchangeable Insulins Could Be Left Out Of Diabetes Treatment ‘Ecosystem’

US FDA assessment of proposed biosimilar and interchangeable insulins in existing delivery forms should be separate from a future determination of whether the products can be safely used as part of a digitally connected treatment system, Lilly says. FDA, AAM representatives suggest this ecosystem approach could become a barrier to access for follow-on products.

The Real ‘Pill Penalty’: US Biosimilar Law, Not The IRA

Biopharma industry is making some modest headway in quest to change the new US Medicare drug price process to treat drugs and biologics on equal footing. But eliminating the so-called ‘pill penalty’ would not on its own equalize the incentives for small molecule and large molecule R&D.

Medicare Price Negotiation Poses Challenges For Safety Net Providers

New drug pricing program under the Inflation Reduction Act could reduce the value of the 340B drug discount for safety net providers by as much as $1 billion in the first year, an analysis by the 340B Health association suggests.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS125292

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