April 27, 2017
April 27, 2017
On Friday, April 21st, Reneflexis® (SB2, infliximab – abda) was approved by the FDA. Reneflexis is manufactured by Samsung Bioeipis, and is a biosimilar product to Janssen’s Remicade® (infliximab). Reneflexis is the fifth biosimilar product, and the second infliximab biosimilar approved by the FDA.
The FDA approved Reneflexis for all eligible indications, which include the following:
The FDA accepted the product for review in May 2016, and this is the first Samsung Bioepis product that has been approved by the Agency for sale in the US.
April 7, 2016
On Tuesday, April 5th, FDA announced the approval of Inflectra™ (infliximab-dyyb), a biosimilar version of Janssen Biotech's Remicade® (infliximab), for a number of indications. Inflectra is...
September 6, 2016
On Wednesday, August 30th, the FDA announced the approval of Sandoz’s Erelzi™ (etanercept-szzs). Erelzi is biosimilar to Amgen’s Enbrel® (etanercept) and is indicated for the treatment of multiple...
November 24, 2015
Recently, biosimilars have made a definite appearance on the FDA’s radar, an expected result after the first biosimilar product gained FDA approval in March and the FDA’s release of four final...