Dear friends and readers, I hope you would have enjoyed reading our previous issue. Once again, I am delighted to bring to you the July 2019 edition of Microbioz India magazine, supported by the cover story entitled “Biologics vs Biosimilars : Research and Development in Pharma” a review study on comperative study of Biosimilars and Biologics.A biosimilar is exactly what its name implies — it is a biologic that is “similar” to another biologic medicine (known as a reference product) which is already licensed by the U.S. Food and Drug Administration (FDA).
Biosimilars are highly similar to the reference product in terms of safety, purity and potency, but may have minor differences in clinically inactive components. In approving biosimilars, the FDA may require that manufacturers conduct a clinical study (or studies) sufficient to establish safety, purity or potency in one or more uses for which the reference product is licensed and the biosimilar seeks licensure.
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