Posted by Michael Wonder on 31 May 2017
Sandoz proposed biosimilars adalimumab and infliximab accepted for regulatory review by the European Medicines Agency
31 May 2017 - These regulatory submissions follow soon after two positive CHMP opinions for Sandoz biosimilars etanercept and rituximab further reinforcing Sandoz immunology pipeline and the broader Novartis immunology portfolio.
Sandoz, a Novartis division, and the pioneer and global leader in biosimilar medicines announced today that the EMA has accepted for regulatory review their marketing authorisation applications for biosimilars to AbbVie's Humira (adalimumab) and Janssen's Remicade (infliximab) both of which are used to treat immunological diseases. Sandoz is seeking approval for biosimilar adalimumab and infliximab for use in all indications of their respective reference medicines.
The comprehensive data packages included in the EMA submissions demonstrate biosimilarity of the proposed biosimilars to their respective reference medicines, with analytical, preclinical and clinical data matching across quality, efficacy and safety.
The biosimilar adalimumab submission included clinical data from pharmacokinetic studies and a Phase III confirmatory efficacy and safety study in patients with moderate to severe chronic plaque psoriasis.
The biosimilar infliximab submission included clinical data from a pharmacokinetic study and a Phase III confirmatory efficacy and safety, study in rheumatoid arthritis.
