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Proposed Biosimilars to Humira, Remicade Accepted for Review by EMA
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Sandoz’s proposed biosimilars to Humira and Remicade were accepted for regulatory review by the European Medicines Agency, according to a company release.
“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,” Global Head of Development, Biopharmaceuticals at Sandoz Mark Levick, MD, PhD, said in the release.
For its proposed biosimilars, Sandoz is seeking approval for all current indications of adalimumab (Humira, AbbVie) and infliximab (Remicade, Janssen).
“The [European Medicine Agency’s] EMA’s acceptance of our regulatory submissions for our biosimilar adalimumab and infliximab is a significant step towards improving patient access to these import biologic medicines, both of which are part of our steadily advancing immunology pipeline,” Levick said.
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