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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