Abstract:

Biosimilars or similar biologics are pharmaceutical products mimicking the already marketed biological medical product. It is just like the innovator product. Biologics or biopharmaceutical is any pharmaceutical drug product synthesized, extracted from, or semi-synthesized from biological sources. They could be vaccines, blood, blood components, allergenic, somatic cells, gene cures, tissues, recombinant therapeutic protein, and living cells used in cell remedies. Biologics may be sugars, proteins, nucleic acids, or a complicated combination of those materials, or can be live cells or tissues. They (or their precursors or components) are obtained from living sources—human, animal, plant, fungal, or microbial. Various terminologies are used to define Biosimilars by different regulatory bodies. Such names terminologies include Follow-on Biologics (US-FDA, Brazil), Similar Biotherapeutic Product (WHO), Similar Biologics (India), Biosimilar (Europe), and Subsequent entry Biologics (Canada).

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