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

Sanofi's Admelog, a Humalog Follow-On, Approved In US As 'Black Hole' For Insulins Looms

Executive Summary

Short-acting insulin approved under 505(b)(2) pathway appears poised to receive three years of Hatch-Waxman exclusivity but would lose nine months of this protection under FDA's current interpretation of the 'transition provisions' for certain protein products that take effect in March 2020.

You may also be interested in...



Sanofi's Vaccines Performance Helps Offset Diabetes Decline

Performance of Dupixent, which just picked up a new indication, was a third quarter highlight and bodes well for future growth, but sales of the blockbuster insulin glargine Lantus are crumbling.

Keeping Track: Mylan Wins First US FDA Approval For Neulasta Biosimilar, But Lands A CRL For Insulin Glargine; Genentech Nabs Broad Full Approval For Venclexta, PV Indication For Rituxan

The latest drug development news and highlights from our US FDA Performance Tracker.

Lowering Insulin Costs: Sanofi Seeks HHS Support For Expanding Assistance To Medicare Patients

HHS endorsement of company-sponsored discount programs for cash-paying customers with Medicare would be preferable to lowering list pricing.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

GB150348

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