BIOSIMILARS GET APPROVAL FOR INTERCHANGEABILITY IN EU
News:
European Medicines Agency and a network of the heads of the authorities responsible for the regulation of medicinal products for human use in the European economic area, issued a statement that biosimilar medicines approved in the European Union (EU) are interchangeable with their reference medicine or with an equivalent biosimilar.
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Interchangeable status is significant for the revenue-generating potential as interchangeable designation and subsequent lower-price contracting, leaves the decision making regarding automatic substitution at pharmacy level. This increases the competitive intensity for biosimilars in Europe although with positive implications for the likes of Biocon, Zydus Life and Lupin.
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