EU green-lights Samsung Bioepis, Biogen’s Remicade biosimilar Flixabi

pharmafile | May 31, 2016 | News story | Manufacturing and Production, Research and Development, Sales and Marketing Biogen, Samsung Bioepis, biosimilar, drug trial, regulation, research 

Samsung Bioepis and partner Biogen (Nasdaq: BIIB) said the European Commission has approved Flixabi, a biosimilar version of Johnson & Johnson (NYSE: JNJ) and Merck & Co’s (NYSE: MRK) Remicade (infliximab).  

Flixabi is indicated as a treatment for rheumatoid arthritis (RA), Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis.

Alpna Seth, global head of the biosimilars business unit at Biogen said: “The approval of Flixabi marks a major step forward for both Samsung Bioepis and Biogen. It expands our anti-TNF portfolio and furthers Biogen’s commitment to commercializing biosimilars of advanced biologics, while expanding cost-effective treatment options for patients living with chronic inflammatory conditions such as Crohn’s disease and ulcerative colitis.”

Flixabi will be the second anti-TNF biosimilar to be manufactured and commercialized by Biogen in the EU. Earlier this year, Samsung Bioepis received approval for Benepali (etanercept), a biosimilar copy of Amgen’s (Nasdaq: AMGN) Enbrel.

At an estimated $10 billion a year, anti-TNF therapies are among the EU’s largest drug expenditures, the companies said in a joint statement.

Anjali Shukla

Related Content

Alvotech and JAMP Pharma’s Jamteki gains marketing authorisation from Health Canada

Alvotech and JAMP Pharma have announced that Health Canada has granted JAMP Pharma marketing authorisation …


Eisai shares new data for Leqembi for Alzheimer’s treatment

Eisai and Biogen have announced that Eisai has shared new data for Leqembi (lecanemab-irmb) 100mg/mL …

Biogen’s biosimilar Tofidence approved by FDA

Biogen has announced that the US Food and Drug Administration (FDA) has approved Tofidence (tocilizumab-bavi) …

Latest content