Lupin’s marketing authorization application (MAA) for biosimilar Etanercept has been accepted for review by Europe drug regulator, European Medicines Agency (EMA).
MAA means an application submitted by a drug manufacturer seeking permission, from the regulator to sell the drug. Etanercept is suggested for treating Rheumatoid Arthritis (RA), Psoriatic Arthritis, Ankylosing Spondylitis, Axial spondyloarthritis, Non-radiographic axial spondyloarthritis and Plaque Psoriasis.
Furthermore, Lupin’s MD Nilesh Gupta stated, “The application for our Etanercept biosimilar and its acceptance in Europe is a significant milestone for our foray into biosimilars in key developed markets. This is also an encouraging development as we continue building our pipeline of higher complexity products.”
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