New Proposed European Commission Pharmaceutical Regulation – Potential Changes and Impact on Biosimilars

OBJECTIVES: To review the implications of the proposed changes in the European Union (EU) Commission pharmaceutical legislation and the impact on manufacturers of biosimilar medicines.

METHODS: We will review the EU pharmaceutical legislation and compare the implications of the new legislation and how these changes affect biosimilar drugs.

RESULTS: Comparing the current biosimilar environment vs. the new legislation, where evidence submission for bioequivalence will be abolished. The bolar exemption covers all studies and trials for marketing authorisation, healthcare technology assessment, pricing and reimbursement. The risk management plan is also no longer necessary if there are no additional risk mitigation measures available for the reference product, resulting in less cost overall post-marketing authorisation for biosimilars.

CONCLUSIONS: Under the new EU legislation, biosimilars are able to enter the market sooner due to shorter Regulatory Data Protection exclusivity and a less costly post-marketing authorisation.