Biosimilars in development

The rest of the Atlas records what regulators have approved. This page looks one step earlier, at the trials a company runs before it files. Every biosimilar programme has to compare its candidate with the reference product, usually first in healthy volunteers for pharmacokinetics and then in patients for efficacy and safety, and those trials are registered in public before they start. Reading the registry therefore shows which candidates exist and roughly how far along they are, a year or more before any approval appears.

The list is built from ClinicalTrials.gov. For each molecule in the Atlas we pulled every record that mentions the word biosimilar and kept the trials that compare a named candidate with the reference product in two or more arms. Single-arm studies, observational studies and treatment trials that merely use a biosimilar as background therapy are left out. Each trial is then matched to the register: where the candidate already has an approval somewhere in the seven markets, the row links to that product; where it has none, the candidate is marked as not yet approved. Those unmatched candidates are the useful part, because they are the products that may arrive next.

Three limits are worth knowing. The data is entered by sponsors and not checked by any regulator, so a trial marked as recruiting may have finished long ago and dates slip without notice. Programmes registered only on national registries, such as India's CTRI or China's ChiCTR, are not captured, which means Indian and Chinese domestic programmes are under-counted. And a sponsor that registers a study under a code name without the word biosimilar will be missed until we widen the net. Treat the page as a map of what is visible, not a complete census.

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