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Merck Sharp and Dohme reports positive data from biosimilar arthritis drug trials
Merck Sharp and Dohme and Samsung Bioepis have announced positive data from phase III clinical trials of their new biosimilar therapies for rheumatic diseases.
The clinical studies of SB4 – an investigational biosimilar of Enbrel – and SB2, a biosimilar version of Remicade, demonstrated equivalence to the originator medicines in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy.
Additionally, three phase I studies of SB4, SB2 and SB5 demonstrated the pharmacokinetic equivalence of each of these biosimilar candidates to their respective originator products.
These results were presented for the first time at the European League Against Rheumatism's annual meeting in Rome.
Dora Bibila, associate vice-president and general manager of Merck's biosimilars business, said: "We are excited by the opportunity to leverage the extensive capabilities of our two companies in the emerging biosimilars marketplace to help meet the growing needs of patients and healthcare systems worldwide."
Biosimilars are an important new area of medicine, offering comparable performance to their originator medicines, but at a much lower price.
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