Session 2 – Track “Perspectives” | Regulatory Perspectives for Biosimilar Development
Biosimilars represent an opportunity to address the affordability challenges on Access to Biologic Therapies as long as demonstrated comparable efficacy and safety is preserved. However, regulatory and public health considerations for the public, biosimilar developers, and government regulators remain to be addressed. Issues such as naming, traceability, pharmacovigilance are still a concern; as well as other technical regulatory considerations as to the minimum clinical safety and efficacy data to support comparable quality of biosimilar candidates. These topics will be discussed from a multi-stakeholder perspective of patients, regulators, academics, and researchers.
- Valeria Pallavicini, Director of Evaluation and Registration of Medicaments, ANMAT (Argentine)*