Generics Bulletin 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

Pfenex And Alvogen May Face Delay In Teriparatide Equivalence Rating

Executive Summary

Pfenex remains hopeful of receiving US approval for its teriparatide hybrid rival to Eli Lilly’s Forteo in October this year. But commercial partner Alvogen may have to wait for a therapeutic equivalence rating to the osteoporosis original.

You may also be interested in...



Keeping Track: Scenesse, Reyvow, and Beovu Make Trio Of Novel Approvals

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

Pfenex Gets US Teriparatide Nod

Pfenex’ PF708 version of Forteo, submitted under the US 505(b)(2) hybrid regulatory pathway, has been approved by the FDA. Marketing partner Alvogen is expected to launch as soon as the FDA decides on the product’s equivalence rating after Pfenex submits a key study.

Teva Expects Launches To Hold North American Generics Sales At $4bn Per Year

With a roster of launches planned over coming months, Teva is confident it can keep returning sales by its North American Generics operation in the region of $1bn per quarter.

Related Content

Topics

UsernamePublicRestriction

Register

GB140602

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