FDA ConneKTion

Timely updates and insights on the latest issues affecting FDA-regulated companies from Kilpatrick Townsend

Archive for September 2016

Posted on Tuesday, September 13 2016 at 8:58 pm by -

Just Use Soap and Water . . . . FDA Issues Final Rule on the Safety and Effectiveness of Antibacterial Soaps and Body Washes

By: Carolina M. Wirth

The Food and Drug Administration (FDA or Agency) issued a Final Rule last week establishing that over-the-counter (OTC) consumer antiseptic wash products[1] containing certain active ingredients are no longer generally recognized as safe and effective (GRAS/GRAE) and as a result cannot continued to be marketed.  The Final Rule applies to consumer antiseptic wash products intended to be used with water and rinsed off after use, including antibacterial soaps, hand washes and body washes.[2]  However, excluded from the Final Rule are healthcare antiseptics (80 Fed. Reg. 25,166), consumer antiseptic rubs (81 Fed. Reg. 42,912), antiseptics identified as “first aid antiseptics” and found in the 1991 First Aid Tentative Final Monograph (56 Fed. Reg. 33,644), and antiseptics used by the food industry.[3]


Read the rest of the entry…

Posted on Tuesday, September 6 2016 at 3:39 pm by -

Sandoz Wins FDA Approval for First Biosimilar of Amgen’s Enbrel®

By: Jennifer Giordano-Coltart Ph.D.

On August 30, 2016, the Food and Drug Administration (FDA) approved the third U.S. biosimilar product – Sandoz Inc.’s (Sandoz) biosimilar of Amgen Inc.’s (Amgen) blockbuster Enbrel® (etanercept) – pursuant to the Biologics Price Competition and Innovation Act of 2009 (BPCIA).[1] Sandoz’s biosimilar, GP2015, will be marketed as Erelzi® (etanercept-szzs) and has been approved for all indications on the label of its reference product Enbrel®, including ankylosing spondylitis, plaque psoriasis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, and rheumatoid arthritis. The approval was expected following the unanimous vote for approval of the FDA’s Arthritis Advisory Committee in July.[2]  In approving GP2015, the FDA concluded that the biosimilar was highly similar to U.S.-licensed Enbrel®, notwithstanding minor differences in clinically inactive components.  FDA also found no clinically meaningful differences between GP2015 and the reference product in terms of the safety, purity, and potency of the product.  Sandoz’s abbreviated Biologic License Application (aBLA) was supported by comparative pharmacokinetic studies in healthy volunteers and a confirmatory efficacy and safety similarity study in patients with chronic plaque psoriasis.  Of note, the results of these studies were extrapolated to support approval of GP2015 for all other indications for which the reference product is approved.  While approved as a biosimilar of Enbrel®, GP2015 was not approved as an interchangeable product, though additional studies may support such a finding in the future.


Read the rest of the entry…