The European Medicines Agency (EMA) has accepted for regulatory review Marketing Authorization Applications for biosimilars to AbbVie's Humira (adalimumab) and Janssen's Remicade (infliximab).- Sandoz

Sandoz, a Novartis division, and the pioneer and global leader in biosimilar medicines announced that the European Medicines Agency (EMA) has accepted for regulatory review their Marketing Authorization 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 (PK) 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 PK study and a Phase III confirmatory efficacy and safety, study in rheumatoid arthritis.

Comment: Sandoz acquired the rights from Pfizer for the development, commercialization and manufacture of PF-06438179 in the 31 countries that form the European Economic Area (EEA) in February 2016 where it is known as GP 1111. Pfizer retains commercialization and manufacturing rights to infliximab in all countries outside of the EEA..