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

Biocon Gets FDA Observations At Key Biosimilars Facilities

US Agency Finds Multiple Form 483 Deficiencies Across Bengaluru And Malaysia Sites

Executive Summary

Biocon has revealed that an FDA inspection of key biosimilars manufacturing facilities in Bengaluru and Malaysia in August has resulted in numerous Form 483 observations across three Biocon Biologics sites.

You may also be interested in...



Viatris Swats Away Concerns Over Divestment Valuations

Viatris remains committed to completing the sale of its global biosimilars unit to Biocon Biologics, while continuing efforts to generate up to $9bn in pre-tax proceeds by the end of 2023 from divestments.

Biocon Insulin Aspart US Opportunity: 'Not Completely Lost But Not The Best Situation'

Biocon may not be able to make it to the current contracting cycle in the US for its Viatris-partnered biosimilar aspart, but all is not lost, the management indicates. The Indian firm is also buoyant about the prospects of taking its franchise of potentially interchangeable recombinant human insulin to the US.

Biocon Joins Fray For Denosumab, Ustekinumab Biosimilars

Biocon is progressing trials for biosimilar rivals to Amgen’s Prolia/Xgeva (denosumab) and J&J’s Stelara (ustekinumab), even as it gears for other large opportunities coming its way via the Viatris deal including for blockbusters Humira and Eylea.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

GB152128

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