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23 Apr 2017

USFDA Approves Renflexis Biosimilar to Remicade

USFDA approved another alternative version of Remicade, an expensive injected drug widely used for rheumatoid arthritis and other immune system disorders.

The U.S. Food and Drug Administration approved Renflexis, developed by Samsung Bioepis Co. of South Korea. Its U.S. partner, Merck & Co. of Kenilworth, New Jersey, will market Renflexis.

List of Biosimilar approved by USFDA tilldate 

US approval Year of Approval Biosilimar Brand Company Biomolecule Reference Product Company
1st Biosimilar 2015 Zarxio Sandoz Filgrastim Neupogen Amgen
2nd Biosimilar 2016 Inflectra Celltrion Infliximab Remicade Janssen Biotech
3rd Biosimilar 2016 Erelzi Sandoz Etanercept Enbrel Amgen
4th Biosimilar 2016 Amjevita Amgen Adalimumab Humira AbbVie
5th Biosimilar 2017 Renflexis Samsung Bioepis Infliximab Remicade Janssen Biotech

Renflexis, which is a version of infliximab, is a treatment of rheumatoid arthritis, ankylosing spondylitis and Crohn’s disease in adults. Its reference drug is Remicade, blockbuster drug sold by Janssen, a pharmaceutical division of multinational medical company Johnson & Johnson.

The company had filed for the U.S. FDA approval in March last year.

In Korea, the drug was approved by the Ministry of Food and Drug Safety December 2015 under the brand name of Renflexis. It also gained marketing approval in Europe and Australia last year. It is sold as Flixabi in Europe.

KPE-C-022 – KPE’s Certificate Program in Biologic (Biotech and Biosimilar) Regulation & Strategic 

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