Regulatory Affairs

Convergence as an access policy

Regulatory pathways determine how fast a quality biosimilar reaches patients. Divergent requirements across countries multiply the cost of development and delay access, especially for Emerging Biopharmaceuticals manufacturers serving several markets at once.

The hub promotes science-based, convergent regulation and reliance between authorities, and brings the manufacturer perspective to ICH, WHO, PAHO and BRICS technical discussions.

What the hub does

• Dialogue with regulators: the 2026 Global South conversation on biosimilars convened authorities from Argentina, Brazil, Chile, Egypt, India, Kenya, Malaysia, South Africa, the European Union and Austria.
• Monitoring of regulatory developments for biosimilars, vaccines and novel biologics in member markets.
• Position papers and input to international consultations.
• Peer learning on dossiers, comparability exercises and post-approval changes.