Pink Sheet 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


Celltrion Biosimilar Is Latest To Run Into GMP Compliance Concerns

Executive Summary

An FDA inspection uncovered a wide-ranging list of GMP problems at biopharmaceutical manufacturer Celltrion in South Korea. Among some of the problems that inspectors found were mold on walls in sterile areas, operators leaning over sterile areas with bare hands and arms, and employees using shared passwords. A resulting Form 483 report is the latest in a number of recent enforcement actions targeting proposed biosimilar drugs.

You may also be interested in...

Keeping Track Of Bad News: Alkermes' Depression Candidate Gets Refuse To File; Teva/Celltrion Biosimilars Land CRLs

The dark side of US FDA review news this week. 

FDA Warning Letter Calls Attention to Celltrion's 'Poor' Aseptic Practices

FDA warning letter to South Korean manufacturer Celltrion cites an extensive list of problems related to inadequate contamination controls and shows how companies launching biosimilars can be tripped up by GMP compliance problems.

More Questions As Biocon Pulls EU Filings For Two Biosimilars

Biocon and partner Mylan have withdrawn the European application for their biosimilar trastuzumab and pegfilgrastim in the backdrop of compliance blips at Biocon’s Indian site, raising critical questions on how soon things can be set right in an increasingly competitive scenario.

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