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

Not A Biosimilar: Mylan’s Insulin Glargine ‘Deemed’ A BLA With Long-Awaited US FDA Approval

Executive Summary

Semglee, a follow-on version to Sanofi’s Lantus, finally wins approval more than two months after insulin products transitioned to regulation as biologics; the product is not a biosimilar but can serve as a reference biological for future biosimilar or interchangeable applications from other sponsors.

You may also be interested in...



With Interchangeability Nod, Viatris' Semglee Loses Its Identity

Now approved as an interchangeable biosimilar, US labeling for Viatris’ insulin aspart mirrors that of Sanofi’s Lantus and has shed data from two studies in type 1 and 2 diabetics that showed noninferiority to Sanofi’s Lantus; Viatris appears in line for one year of exclusivity.

Biosimilars: US FDA Developing Guidance For First Interchangeable Exclusivity

The first biosimilar with interchangeability status compared to its reference will be entitled to one year of exclusivity, a largely overlooked advantage in the early days of the US biosimilar market.

Biosimilars: US FDA Developing Guidance For First Interchangeable Exclusivity

The first biosimilar with interchangeability status compared to its reference will be entitled to one year of exclusivity, a largely overlooked advantage in the early days of the US biosimilar market.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS142359

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