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OPPORTUNITY OF A NEW CLASS OF BIOSIMILAR ORPHAN BIOLOGIC MEDICINES OFFERING ACCESS TO AFFORDABLE MEDICINE

Advancement in biosimilar development and approvals EU and USA

The European Legislation for medicines has formed the basis of a regulatory pathway laid down by the European Medicines Agency (EMA) since 2004 by which biologics similar to ones already on the market can get approved with an abbreviated development programme.

By the E MA d efinition “A biosimilar is a biological medicinal product that contains a version of the active substance of an already authorised original biological medicinal product (reference medicinal product) in the European Economic Area (EEA).” The US Food and Drug Administration (F DA) the d efinition is equivalent but more precise, namely, “A “biosimilar” is highly similar to the reference product notwithstanding minor differences in clinically inactive components and no clinically meaningful differences in terms of safety, purity and
potency.”

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