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

Mylan's Herceptin Advisory Committee May Be First Bumpy One For A Biosimilar

Executive Summary

US FDA did not address production problems in its briefing document for upcoming Oncologic Drugs Advisory Committee meeting, but manufacturing deficiencies found at Biocon's facility could prompt questions.

You may also be interested in...



Will GMP Lapses Stall Biocon-Mylan’s Biosimilars Build-Up?

Compliance deviations flagged by French regulator ANSM at Biocon’s Indian site have raised questions around commercialization timelines in the EU for the firm and partner Mylan’s biosimilars, including trastuzumab. The news comes ahead of an FDA advisory panel review later this week for the product. Biocon, though, appears confident of setting compliance woes right quickly.

Pfizer’s EPO Biosimilar Stalls In US On Hospira Compliance Woes

US FDA hands Pfizer its second complete response letter for its proposed biosimilar to Epogen/Procrit, citing manufacturing compliance concerns at a legacy Hospira manufacturing facility in Kansas that was the target of a February warning letter. Issue “is not directly related to EPO itself,” Pfizer’s Salomon Azoulay says.

EU, US Finally Agree On Mutual Recognition Of GMP Inspections

Reliance on each other’s good manufacturing practice reports should allow EU and US regulators to better focus their limited inspection resources on drug manufacturers in other countries around the world.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

GB001928

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