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The Food and Drug Administration’s Arthritis Advisory Committee (AAC) yesterday recommended that the Sandoz etanercept (Enbrel) biosimilar (GP-2015) be approved for use in the United States. Upon review of the data, the panel unanimously voted 20-0 that GP-2015 be recommended for use in the same indications as etanercept: rheumatoid arthritis (RA), juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis and plaque psoriasis.
GP-2015 is an etanercept biosimilar that targets tumor necrosis factor-alpha (TNF-α) in the management of RA, psoriasis and multiple inflammatory diseases.
Enbrel was approved in 1998 and last year generated $5.4 billion in U.S. sales. Sandoz/Novartis was the first to launch a biosimilar in the USA (Zarxio/Neupogen), Europe, Canada, Japan and Australia.
The biosimilarity of GP-2015 to etanercept was confirmed by in vitro assays, pharmacokinetic studies peptide mapping, FTIR (higher order structure), X-ray crystallography, immunogenicity studies, and TNFα binding and neutralization and stability behavior.
The discussion of this biosimilar hearing was similar to Tuesday's hearing on the Amgen adalimumab biosimilar ABP-501, and the criteria necessary for biosimilarity and presented limited clinical trial data on patients with psoriasis.
Unlike other biosimilar studies (Inflectra, ABP-501) that performed clinical trials in RA, the clinical equivalence trials for GP-2-015 were established in psoriasis patients. Psoriasis was chosen as it was thought to be the most sensitive of all the Enbrel indications to detect a potential difference with GP-2015. Moreover, the psoriasis trials have the advantage of a large effect size, reliable (visible) standardized outcomes (PASI), younger healthier patients with little or no comorbidities and presumably the same mechanism of action as RA, AS and other indications.
For example, the GP15-302 study assessed moderate to severe plaque psoriasis patients with PASI >10 and BSA >10 and a previous history of systemic or phototherapy. After 12 weeks of treatment, the PASI75 responses were 73.4% (GP-2015) and 75.4% (etanercept). During extension period (Period 2), patients were switched between etanercept and GP-2015 without loss of effect or toxicity. Overall, these studies showed no new or unexpected safety signals with the new biosimilar, GP-2015.
GP-2015 will be available in the same doses and delivery forms as the originator product Enbrel; as an injectable solution in a prefilled syringe or autoinjector with the same strengths (25 mg/0.5 mL or 50 mg/1.0 mL) as etanercept for the same indications.
GP-2015 becomes the 3rd biosimilar to be recommended by the FDA’s arthritis advisory board in the last 6 months. Soon after Inflectra was recommended by the AAC, the FDA approved the drug about 8 weeks later. However, the availability of Inflectra and these new TNF targeted biosimilars is likely to be many months away, probably not until 2017.