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


Complex Products At US FDA: Adamis' Epi-Pen Alternative OKed; Sandoz Advair ANDA Accepted

Executive Summary

The latest regulatory news on new versions of complex products and delivery systems from our FDA Performance Tracker.

You may also be interested in...

Taking Biosimilars Down A PEG: Why Copying Neulasta Isn’t So Easy

Biosimilar sponsors are 0-3 so far in attempts to win US FDA approval for copies of Amgen’s pegfilgrastim (Neulasta). FDA’s recent review of a novel clotting factor formulation offers a clue why it is turning out to be harder than it seems to copy a pegylated protein.

Neulasta Biosimilar From Coherus Needs Better Immunogenicity Assay After Stumble At US FDA

Despite facing one-year delay, Coherus is buoyed by FDA’s apparent support for its decision not to conduct clinical study in cancer patients; agency requests company develop more sensitive immunogenicity assay and reanalyze subset of samples from study conducted in healthy subjects.

Mylan's Next Up For A Shot At Neulasta Biosimilar After Coherus CRL

FDA issued a complete response letter to Coherus' application for a biosimilar version of Amgen's Neulasta (pegfilgrastim), giving Amgen a reprieve, though Mylan has an application pending at the US agency.

Related Content


Related Companies

Latest Headlines
See All



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