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

UsernamePublicRestriction

Samsung’s Renflexis: Second US Biosimilar To Janssen’s Remicade, With A Few Firsts

Executive Summary

Infliximab-abda gains FDA licensure without having faced an advisory committee review; under current case law, launch could come as early as mid-October.

You may also be interested in...



VA Changes Infliximab Biosimilars; Merck Formulary Win Could Drive Questions On Patient Switching

Move from one infliximab biosimilar to another could illuminate safety concerns surrounding non-medical switching – or at least Janssen hopes so; VA's national formulary moved from Remicade to Pfizer's Inflectra in 2017.

VA Changes Infliximab Biosimilars; Merck Formulary Win Could Drive Questions On Patient Switching

Move from one infliximab biosimilar to another could illuminate safety concerns surrounding non-medical switching – or at least Janssen hopes so; VA's national formulary moved from Remicade to Pfizer's Inflectra in 2017.

Samsung's Biosimilar Manufacturing Documents Lead Janssen To Drop Infringement Suit

Janssen concludes the manufacturing processes for Renflexis do not infringe its Remicade patents, clearing Samsung and partner Merck from potential damages resulting from their at-risk launch of the biosimilar; innovator's legal action remains against Inflectra partners Pfizer and Celltrion.

Related Content

Topics

Related Companies

Latest News
UsernamePublicRestriction

Register

PS120476

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