Are there potential risks in using biosimilar drugs?
Like all drugs, biosimilars may occasionally produce unpredictable effects. It is therefore very important that the safety of all drugs, including biosimilars, continue to be monitored after authorisation. Due to the potential for small differences between the original biological drug and the biosimilar, the long-term safety of biosimilars is less predictable than for generics. The nationalregulatory body in the UK, the Medicines and Healthcare Regulatory Authority (MHRA), therefore requires strict vigilance to be in place for biosimilar drugs as for all biological drugs.
