Pink Sheet 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

First Lucentis Biosimilar Among Drugs Awaiting Verdict On EU Approval Filings

Executive Summary

Sponsors of several new medicines, including the first ever CAR-T for multiple myeloma, will find out this week if their products are on track to get EU marketing authorizations. Also, three sponsors might be asked to address outstanding issues about their products in the final stages of review.

You may also be interested in...



EMA OKs BMS/bluebird bio’s CAR-T Abecma For Multiple Myeloma

A gene therapy for multiple myeloma, a new drug for achondroplasia, and the first biosimilar version of Roche’s Lucentis are among eight products recommended for EU marketing authorization this week.

Samsung Bioepis Backed By EMA For First Lucentis Biosimilar

Samsung Bioepis is set to make waves with the first ophthalmic biosimilar after the European regulator recommended that its ranibizumab biosimilar Byooviz receive a pan-European marketing authorization.

Incyte/MorphoSys Await EU Verdict On Tafasitamab For DLBCL

Is the benefit-risk profile of tafasitamab good enough for it to be recommended for EU-wide marketing approval? Codevelopers Incyte and MorphoSys may find out this week.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS144534

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