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.



Agency Alerts

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...

Read the Full Article
Agency Alerts General Regulatory

June 9, 2016

FDA Simplifies Process for Requesting Expanded Access to Investigational Drugs

On Thursday, June 2nd FDA released the final Individual Patient Expanded Access Investigational New Drug Application (Form FDA 3926), which is a new form for physicians to use when requesting...

Read the Full Article
General Regulatory Regulatory Sciences

April 26, 2012

Cetero FDA Action

If your company has used Cetero Research's Houston facility to conduct bioanalytical studies between April 1, 2005 and June 15, 2010, your marketing applications may need to be repeated or confirmed....

Read the Full Article