Biosimilars and National One Health Mission Assembly 2025
Context:
The union Health minister recently inaugurated the National One Health Mission Assembly 2025
The theme is Translating Knowledge to Practice - One Earth, One Health, One Future.
The event highlighted the Mission's role in strengthening pandemic preparedness through a whole-of-government approach.
About Biosimilars:
"Similar biologics", also knows as Biosimilars, refer to biologic products that are highly similar to an existing, licensed reference biological product (RBP).
The concept includes products made using recombinant DNA technology that demonstrate no clinically meaningful differences from the reference product
Unlike simple chemical drugs, biosimilars are biologics (for example, antibodies) derived from living organisms.
They possess complex structures characterized by specific protein folding and glycosylation patterns (sugar attachments).
Due to this biological complexity, it is impossible to make an absolutely identical copy of the original parent molecule.
Regulatory authority for Biosimilars:
Central Drugs Standard Control Organisation (CDSCO) — the apex drug regulator under the Ministry of Health & Family Welfare (MoHFW).
Department of Biotechnology (DBT), under the Ministry of Science & Technology, which oversees biotechnologyaspects (e.g., recombinant DNA, cell banks) and works in tandem with CDSCO for biologics regulation
Biosimilars vs. Generics:
Composition:
Generics are chemical compounds that are synthesized to be identical to the brand-name drug.
Biosimilars are large, complex biological molecules that are highly similar but may have slight differences in structure (e.g., glycosylation).
Testing & Approval:
Genetics generally require bioequivalence studies.
Biosimilars require a degree of clinical trials to demonstrate equivalence to the reference product, as simple chemical analysis is insufficient to predict their behaviour in the body.
Economic Impact:
Generics typically offer massive cost reductions compared to the branded version.
Biosimilars drive down costs, but the savings are generally not as significant as those seen with generics due to the high cost of manufacturing and testing.