EU review for Sandoz’ Humira, Remicade biosimilars
European regulators have accepted for review Sandoz’ marketing applications for biosimilars to AbbVie’s Humira (adalimumab) and Janssen’s Remicade (infliximab).
The company is seeking approval for its biosimilars for use in all indications of their respective reference medicines, which are used to treat immunological disorders such as rheumatoid arthritis and inflammatory bowel disease.
“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,” noted Mark Levick, global head of development, biopharmaceuticals, at Sandoz.
Sandoz says it is now on track to launch five biosimilars of major oncology and immunology biologics, including adalimumab and infliximab, by 2020.
Amgen’s Amgevita was the first biosimilar of mega blockbuster Humira to win approval in Europe in March this year, while Hospira’s Inflectra was the first biosimilar of Remicade to be approved back in 2013.
Written by Selina McKee
