AUTHOR OF THIS BLOG

DR ANTHONY MELVIN CRASTO, WORLDDRUGTRACKER

Celltrion files Remsima in the United States

 Uncategorized  Comments Off on Celltrion files Remsima in the United States
Aug 182014
 

 

Celltrion files Remsima in the United States:

Celltrion announced that the company, on August 8, 2014, completed the filing procedure to obtain US FDA approval for its infliximab biosimilar. This marks the first 351(k) biosimilar mAb application to be filed in the U.S.A. and the second application for a biosimilar to be filed through the US BPCIA.

READ MORE

http://www.biosimilarnews.com/celltrion-files-remsima-in-the-us?utm_source=Biosimilar%20News%20%7C%20Newsletter&utm_campaign=0b76af10ab-15_08_2014_Biosimilar_News&utm_medium=email&utm_term=0_9887459b7e-0b76af10ab-335885197

Share

First mAb biosimilars backed by EMA advisors

 EU  Comments Off on First mAb biosimilars backed by EMA advisors
Jul 022013
 

Among the latest opinions issued by the European Medicines Agency’s Committee for Medicinal Products for Human Use, perhaps the most eye-catching are recommendations for two biosimilar versions of Johnson & Johnson’s monoclonal antibody blockbuster Remicade.

The CHMP has backed Remsima from South Korea’s Celltrion and Hospira’s Inflectra, both of which contain the same active substance as Remicade (infliximab). They have been recommended for authorisation in the same indications as the J&J drug, ie a range of autoimmune diseases such as rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and and psoriasis.

READ ALL AT

http://www.pharmatimes.com/Article/13-07-01/First_mAb_biosimilars_backed_by_EMA_advisors.aspx

 

Share
Follow

Get every new post on this blog delivered to your Inbox.

Join other followers: