Biosimilars
Development, Approval & Interchangeability — biosimilar vs generic, the comparability exercise, CDSCO-DBT / EMA / US FDA 351(k) pathways, immunogenicity & pharmacovigilance (an RGUHS Paper IV LAQ)
Past RGUHS · 1
RGUHSMay '22
Definition & terminology
- Biosimilar — a biological/biotechnology-derived product that is highly similar to an already-licensed reference biologic (innovator), with no clinically meaningful differences in safety, purity, potency and efficacy, despite minor differences in clinically inactive components — similar, NOT identical.
- Similar Biologic — the Indian regulatory term of art — a product similar in quality, safety & efficacy to an already-authorised Reference Biologic. Even two lots of the same reference biologic are not identical to each other. [CDSCO]
- Reference biologic — the innovator's product approved on a complete (full safety/efficacy/quality) dossier; another similar biologic can never serve as the reference. [CDSCO]
- Distinguish the follow-on terms — generic = follow-on of a small molecule, API identical, shows bioequivalence; biosimilar = follow-on of a biologic, API highly similar, shows biosimilarity; "biobetter" = an engineered improvement (modified glycosylation, longer t½) regulated as a new biologic, not a biosimilar.
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Biosimilars
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