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


Merck’s Revised Biosimilar Strategy Poised To Deliver

This article was originally published in The Pink Sheet Daily

Executive Summary

The big pharma has five biosimilars in Phase III development with its partner Samsung Bioepis, and expects to file them for regulatory approval in 2015 and 2016.

You may also be interested in...

Remicade Biosimilars: Samsung Looks To Follow Celltrion's Footsteps

351(k) application relies on data extrapolation from Phase III trial in rheumatoid arthritis to support approval across infliximab's indications, including inflammatory bowel disease.

Korean Green Light For Samsung Bioepis’s Biosimilar Etanercept

Within just three and a half years since its establishment, Samsung Bioepis has received its first regulatory approval for a biosimilar, meaning the Samsung Group affiliate is now set to release its version of Amgen’s Enbrel (etanercept) in South Korea late this year or early next. It will be the fourth locally developed biosimilar to hit the domestic market and is expected to be priced at about a 30% discount.

Samsung Prepping For First Biosimilar Launch

Samsung Bioepis' biosimilar version of Amgen's rheumatoid arthritis blockbuster Enbrel (etanercept) is set to become the firm’s first biosimilar product to hit the market, possibly being released in South Korea late this year and in Europe in the first half of next year.

Related Content


Related Companies

Related Deals

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