The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has announced a positive opinion for marketing authorisation of Sandoz’s proposed biosimilar, infliximab.
The positive recommendation covers the use of the biosimilar for various gastroenterology, rheumatology and dermatology conditions.
Infliximab is an inhibitor of the tumour necrosis factor (TNF)-alpha protein in certain autoimmune conditions characterised by excess TNF-alpha activity. Excess activity can be harmful or lead to onset of disease.
Sandoz CEO Richard Francis said: “Sandoz is proud to be at the forefront of diversifying the biologics treatment landscape by bringing biosimilar medicines to market for patients living with devastating autoimmune diseases.
“Today’s positive CHMP opinion marks a strong step forward in our efforts to accelerate patient access to biologics, and specifically infliximab, through our leading portfolio.”
The recommendation is based on a comprehensive data package expected to confirm the biosimilarity of infliximab to the reference medicine with analytical, preclinical and clinical data matching across quality, efficacy and safety.
A Phase III confirmatory clinical study conducted in rheumatoid arthritis patients is reported to have met its primary endpoint of equivalent efficacy of the proposed biosimilar as measured by the American College of Rheumatology 20 (ACR20) response at week 14, compared with the reference medicine.
In February 2016, Sandoz gained the development, commercialisation and manufacturing rights of infliximab from Pfizer for the 28 European Union (EU) markets, Norway, Iceland and Liechtenstein.
Pfizer holds the commercialisation and manufacturing rights to infliximab in other countries.