Why in the News?
While most medicines are small molecule drugs with simple structures, a newer class—biologics and biosimilars—is reshaping modern medicine with their complex, targeted action.
What are Small Molecule Drugs?
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About Biologics & Biosimilars:
- Biologics-
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- Overview: Large, complex drugs made from living cells or organisms.
- Examples: Insulin (~5,800 daltons), Remicade (~150,000 daltons).
- Nature: Slight structural variations possible; used for cancer, autoimmune diseases, hormone therapy.
- Biosimilars-
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- Overview: Near-identical versions of biologics, made after patent expiry.
- Not Generics: Due to complex cell-based production, they’re similar but not identical.
- Use: Offer lower-cost alternatives to high-end biologics.
Regulation and Reform:
- Current Barriers: Biosimilars need costly trials (animal + clinical), unlike generics.
- Global Moves: UK and USA are easing animal trial norms (organ-on-chip, human models).
- India: Still follows older norms; waivers under review, but clinical trials still mandatory.
Significance for India:
- Access: Generic small molecules transformed Indian healthcare.
- Opportunity: Affordable biosimilars can do the same for chronic and rare diseases.
- Urgency: Regulatory reform is key to reduce costs, speed up access, and widen healthcare coverage.
| [UPSC 2020] What is the importance of using Pneumococcal Conjugate Vaccines in India?
(1) These vaccines are effective against pneumonia as well as meningitis and sepsis. (2) Dependence on antibiotics that are not effective against drug-resistant bacteria can be reduced. (3) These vaccines have no side effects and cause no allergic reactions. Options: (a) 1 only (b) 1 and 2 only* (c) 1 and 3 only (d) 1, 2 and 3 |
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