“That is the kind of thing we are concerned about,” said the WHO’s Cooke.
She hopes the WHO intervention will build confidence in biosimilars by ensuring they are comparable to originals in terms of quality, safety and efficacy.
Those up to standard will win so-called prequalification status, which means drugs are eligible for procurement by UN and other aid agencies. Prequalification is also increasingly used by countries to guide bulk purchases of medicines.
Indian biotech drugmaker Biocon said the WHO move was a positive development that would enable better access to biosimilars. But others said it could make securing marketing approval in emerging markets harder in future.
Differences between Europe, where biosimilars account for a growing proportion of treatments, and the United States, where uptake has lagged, shows the need for a balance between setting sufficiently high standards and not blocking cheap competitors.
“There’s a stand-off between too much and too little regulation,” said Jayasree Iyer, executive director of the non-profit Access to Medicine Foundation in Amsterdam.
