Biosimilars in the United States: Current Status and Future Implications
Biosimilars in the United States: Current Status and Future Implications
Perspective from Seth Ginsberg
July 13, 2016
2 min read

FDA advisory committee unanimously recommends approval of biosimilar to Enbrel

Perspective from Seth Ginsberg
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The FDA Arthritis Advisory Committee voted 20-0 in favor of recommending the approval of GP2015, Sandoz’s proposed biosimilar to Amgen’s Enbrel.

Sandoz is seeking licensure to use the biosimilar to treat rheumatoid arthritis, polyarticular juvenile idiopathic arthritis (JIA) in patients aged 2 years or older, psoriatic arthritis, ankylosing spondylitis and plaque psoriasis. If approved, Sandoz noted GP2015 will help expand treatment options available to patients, health care providers and payers.

“We are encouraged by today’s favorable advisory committee recommendation for our proposed biosimilar etanercept,” Mark McCamish, MD, PhD, head of global biopharmaceutical development at Sandoz, said in a company press release. “As a global market leader in biosimilars, we are pleased to move one step closer toward our goal of expanding patient access with our proposed biosimilar etanercept, and look forward to continuing to work with the FDA as they complete their review of our application.”

According to the release, analytical, preclinical and clinical studies, including four comparative pharmacokinetic studies in 216 healthy volunteers and a confirmatory efficacy and safety similarity study in 531 patients with chronic plaque psoriasis, demonstrated biosimilarity between the company’s biosimilar etanercept and etanercept.

Despite positive outcomes, panel members raised a few concerns about labeling and post-marketing studies. Andreas M. Reimold, MD, chief of rheumatology at the Dallas VA Medical Center, noted the label for the biosimilar should “clearly state that this is a biosimilar, not an interchangeable drug.”

David J. Margolis, MD, PhD, professor of dermatology and epidemiology at the University of Pennsylvania School of Medicine, stressed the importance of post-marketing studies to “demonstrate that extrapolation was correct and it is in the overall safety of the products long term.”

“I think non-medical switching is a major concern of clinicians and policy makers that we have to have some greater clarification from the agency. If there is some statement to be made, make it soon,” David Solomon, MD, MPH, acting chair on the advisory board and chief of the Section of Clinical Sciences, Division of Rheumatology, Division of Pharmacoepidemiology at Brigham and Women’s Hospital, said. “I think the post-marketing surveillance issues are going to be critical to understand the validity of the extrapolation.”

Mara L. Becker, MD, MSCE, associate professor of pediatrics at the University of Missouri-Kansas City, also noted that with 25 mg/0.5 mL being the lowest strength of GP2015, which corresponds to the approved strengths of Enbrel, some pediatric patients may still be limited with treatment options.

“The reality is that, [with] the data present[ed] today, it was convincing that this application is similar enough to etanercept that I would feel comfortable using it in the children that I treat,” Becker said. “However, at this time, I cannot because there are plenty of kids less than 20 kilos that we may need to use this on. So, with an indication for JIA down to the age of 2 [years], you are limiting some patient accessibility with the current formulations.” – by Casey Tingle