After the 13th European- Genetic Association-European Biosimilar Group meet last week, it was recommended that to license a biosimilar, you do not necessarily have to perform a clinical trial in second indications. This is consistent with the current US and European framework for generics, however, the industry associations and regulators have wavered on their guidelines for additional indications/patient types for biosimilars.

To read more on reactions to this recommendation, continue reading the Biopharma-reporter article here.

Need more information on biosimilars? Our staff can help. To get more information email us at: