Generics Bulletin 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

Pfenex And Alvogen Launch US Teriparatide

First Pfenex Launch Comes As Firm Waits For Equivalence Designation

Executive Summary

Pfenex marketing partner Alvogen has introduced the firm’s Bonsity version of teriparatide in the US. Representing the first Pfenex-developed product to hit the market, the launch comes as the companies are still awaiting a formal equivalence designation from the FDA.

You may also be interested in...



Amphastar’s Forteo ANDA Hit With CRL As Wait Goes On

Amphastar will not be receiving approval in 2022 for its proposed generic version of Eli Lilly’s Forteo (teriparatide) peptide for the treatment of osteoporosis, after the FDA told the company it could not issue an approval at this stage.

The Drugs That Could Face US Generic/Biosimilar Competition In 2021

Other expected generics include Viatris' Perforomist (formoterol fumarate), Pfizer's Sutent (sunitinib), Sanofi's Jevtana (cabazitaxel) and possibly Boehringer Ingelheim's Pradaxa.

Complex Generics: US FDA, Sponsors View Roadblocks Very Differently

As GDUFA III negotiations continue, FDA doesn’t seem ready to make additional changes to approval process, but industry argues guidance practices and communications need fixing and that consumers are missing out on potential savings because of it.

Related Content

Topics

Related Companies

Latest News
UsernamePublicRestriction

Register

GB149985

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