FDA to Review Second Remicade Biosimilar Product

May 26, 2016

Earlier this week Samsung Bioepis announced that FDA has accepted for review its BLA for SB2, a biosimilar version of Remicade (infliximab).  SB2 is indicated for the treatment of rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis, and is the first biosimilar product that the company has submitted.

In reviewing Samsung Bioepis’ BLA, the FDA will assess data from phase I and phase III clinical trials, which compare SB2 to the reference product – Janssen’s Remicade (infliximab).  If approved, the product will be marketed and distributed in the US by Merck.

As it has been less than two months since FDA approved Inflectra, the first Remicade biosimilar, it will be interesting to see what the future holds for Samsung Bioepis’ product.

Do you have a biosimilar or other FDA-regulated product in development?  We can help you develop your 315(k) BLA or any other FDA submission.  To learn more about how we can help you, contact us today.


January 28, 2016

FDA Accepts BLA for Amgen’s Humira® Biosimilar

On November 25, 2015, Amgen Inc. submitted a Biologics License Application (BLA) for ABP 501, the company’s biosimilar candidate to Humira® (adalimumab). Earlier this week, Amgen announced that its...

January 29, 2016

Bill to Support the Development of Regenerative Medicine Introduced in Senate

On Tuesday, January 12, 2016, Senator Tammy Baldwin (D – WI) introduced the “Advancing Standards in Regenerative Medicine Act,” a bill supporting the development of regulatory science and the...

February 3, 2016

FDA’s CBER Announces Invitation to Participate in the Regulatory Site Visit Training Program

On February 2, 2016, the FDA’s Center for Biologics Evaluation and Research (CBER) published its annual invitation for biologics facilities to participate in the Regulatory Site Visit Training...