Novartis and Sandoz’s new biosimilars accepted for EU review

Novartis and Sandoz have announced that their new biosimilar versions of adalimumab and infliximab have been accepted for European regulatory review.

The European Medicines Agency has validated the marketing authorisation applications for biosimilars of AbbVie's Humira and Janssen's Remicade, 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, including rheumatoid arthritis and inflammatory bowel disease.

Comprehensive data packages have been submitted to demonstrate that each biosimilar is able to match its respective reference medicine in terms of quality, efficacy and safety.

Dr Mark Levick, global head of development for biopharmaceuticals at Sandoz, said this represents "a significant step towards improving patient access to these important biologic medicines, both of which are part of our steadily advancing immunology pipeline".

It means Sandoz remains on course to launch five biosimilars of major oncology and immunology biologics, including adalimumab and infliximab, by 2020.

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