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Tuesday 19 March 2019
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Biosimilar adalimumab and infliximab accepted for regulatory review by the EMA

Sandoz has announced that the European Medicines Agency (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.

 

"Patients with autoimmune diseases such as rheumatoid arthritis and inflammatory bowel disease rely on biologic medicines like adalimumab and infliximab to stay well, but unfortunately access to these essential medicines can be limited" said Mark Levick MD PhD, Global Head of Development, Biopharmaceuticals, Sandoz. “The EMA’s acceptance of our regulatory submissions for our biosimilar adalimumab and infliximab is a significant step towards improving patient access to these important biologic medicines, both of which are part of our steadily advancing immunology pipeline”.

 

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.1
  • The biosimilar infliximab submission included clinical data from a PK study and a Phase III confirmatory efficacy and safety, study in rheumatoid arthritis.2

 

References

  1. Blauvelt A et al. A randomized, double-blind, multicenter study to compare the efficacy, safety, and immunogenicity of a proposed adalimumab biosimilar (GP2017) with originator adalimumab Poster #5224 presented at the 2017 American Academy of Dermatology (AAD) Annual Meeting, 3-7 March 2017.
  2. Pfizer Inc. Pfizer Announces Positive Top-Line Results from REFLECTIONS B537-02 Study for PF-06438179 (infliximab-Pfizer) a Potential Biosimilar to Remicade® (infliximab). Available at: http://www.pfizer.com/news/press-release/press-release-detail/pfizer_announces_positive_top_line_results_from_reflections_b537_02_study_for_pf_06438179_infliximab_pfizer_a_potential_biosimilar_to_remicade_infliximab (accessed May 2017).

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