In short: A biosimilar — called a similar biologic in India — is a biological medicine shown to be highly similar to an already approved reference biologic, with no clinically meaningful differences in safety or efficacy. CDSCO approves them under its similar-biologics guidelines. For hospital pharmacies they widen choice and can lower cost; the decision to use or switch rests with prescribers and the formulary committee, and each brand should be tracked separately.
What makes a biosimilar different from a generic
A generic copy of a small-molecule tablet can be chemically identical to the original. Biologics such as trastuzumab, bevacizumab, rituximab or filgrastim are large proteins made in living cells, so no two manufacturers’ products are ever exactly identical. A biosimilar is instead shown, through comparative analytical, non-clinical and clinical data, to be highly similar to its reference product.
How India regulates them
CDSCO first issued guidelines on similar biologics in 2012 and revised them in 2016. In 2025 it published draft revised guidelines that rely more on laboratory comparisons and less on animal studies, and allow confirmatory efficacy trials to be waived in defined conditions. Approval remains product by product: each biosimilar brand has its own marketing authorisation.
What to consider before adding one to the formulary
- Confirm the brand is approved in India for the indication your clinicians use it for.
- Let the prescribers and the formulary committee decide on use and on switching patients between brands.
- Record the brand and batch for every patient, so any side effect can be reported against the right product.
- Handle it exactly like the reference biologic: most need +2 °C to +8 °C storage and a documented cold chain.
- Keep more than one approved brand available for critical molecules, so one manufacturer’s shortage does not stop treatment.
How RS Surgipharm helps
For most biologics in our oncology, nephrology and retina ranges we distribute both the innovator brand and quality-assured Indian brands, so hospitals and patients can choose on clinical need and budget. Every pack ships in a validated shipper with a data logger, and every invoice carries the brand and batch.
Quick answers
- Is a biosimilar the same as a generic?
- No. Generics are chemically identical copies of small-molecule drugs. Biosimilars are highly similar, but not identical, versions of biological medicines, approved on comparative data against a reference product.
- Who decides whether a patient switches to a biosimilar?
- The treating doctor, guided by the hospital’s formulary committee. A distributor or pharmacy should never substitute a biologic brand without the prescriber’s approval.
Sources
This guide is general information for healthcare professionals, procurement teams and patients, not medical, legal or regulatory advice. Rules change; confirm with the relevant authority.