FDA approves Novartis’ biosimilar to treat multiple inflammatory diseases
Posted: 1 September 2016 | | No comments yet
The FDA approval is based on analytical, nonclinical, and clinical data confirming that Erelzi is highly similar to the US-licensed reference product. Clinical studies included four comparative pharmacokinetic (PK) studies in 216 healthy volunteers and a confirmatory efficacy and safety similarity study in 531 patients with chronic plaque psoriasis…
The US Food and Drug Administration (FDA) approved Sandoz’ biosimilar, Erelzi (etanercept-szzs), for all indications included in the reference product label, including rheumatoid arthritis (RA), plaque psoriasis (PsO), psoriatic arthritis (PsA), ankylosing spondylitis (AS) and polyarticular juvenile idiopathic arthritis (JIA).
Erelzi is the second biosimilar from Sandoz, a division of Novartis, approved in the US through the FDA biosimilars pathway established under the Biologics Price Competition and Innovation Act.
“We continue to increase patient access to key treatment options by expanding our offering of biosimilars which helps to reduce costs within the healthcare system” said Carol Lynch, Global Head Biopharmaceuticals, Sandoz.
The FDA approval is based on analytical, nonclinical, and clinical data confirming that Erelzi is highly similar to the US-licensed reference product. Clinical studies included four comparative pharmacokinetic (PK) studies in 216 healthy volunteers and a confirmatory efficacy and safety similarity study in 531 patients with chronic plaque psoriasis.
Extrapolation to all indications approved for use on the reference product label is on the basis that the Sandoz biosimilar etanercept and the reference product are essentially the same.
“Sandoz is proud to have developed two of the three biosimilars that are currently FDA approved, which further demonstrates our commitment to US patients in a growing number of therapeutic areas. We are committed to bringing Erelzi to the US market as soon as possible”.
An application for Sandoz biosimilar etanercept has been accepted by the European Medicines Agency and is currently undergoing review.
Sandoz plans to launch five biosimilars of major oncology and immunology biologics across key geographies by 2020. This will be enabled by 11 filings over a three-year period (2015-2017), with six already submitted.
Indications:
Moderate to Severe Rheumatoid Arthritis (RA): indicated for reducing signs and symptoms, keeping joint damage from getting worse, and improving physical function in patients with moderately to severely active rheumatoid arthritis. Can be taken with methotrexate or used alone.
Moderately to Severely Active Polyarticular Juvenile Idiopathic Arthritis (JIA): indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in children ages 2 years and older.
Psoriatic Arthritis: indicated for reducing signs and symptoms, keeping joint damage from getting worse, and improving physical function in patients with psoriatic arthritis. Can be used with or without methotrexate.
Ankylosing Spondylitis (AS): indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.
Moderate to Severe Plaque Psoriasis: indicated for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
