Biologics are large, complex molecules developed by pharmaceutical companies using a unique manufacturing process. Biosimilars are medicines with similar structures developed after biologic exclusivity periods expire.
Lilly believes biosimilars can greatly benefit patients as long as they are getting the medicines their doctor intended. Lilly also supports safe, reasonable regulations reflecting the uniqueness of biologics with patient safety at the forefront.
We can ensure these regulations are upheld by:
Making science-based decisions.
- Clinical evidence must be at the foundation of all decisions.
- Science-based regulatory reviews should determine if biosimilars meet interchangeability standards.
Keeping the final decision with the doctor.
- Patients should receive the medicines their doctor prescribes.
- Only interchangeable biosimilars should be eligible for automatic substitution by pharmacies.
Monitoring patient safety.
- Small differences in biological medicines’ manufacturing processes can cause difficult-to-predict changes in safety and efficacy.
- Countries with insufficient regulatory standards produce products that pose a risk to patient safety and should not be considered as a "biosimilar."
Guaranteeing identification and traceability.
- Biologics and biosimilars should have unique, differentiating names.
- Strong laws for data exclusivity and patent protection strike the balance between patient access and innovation of new medicines.
Read more about Lilly’s position on biosimilars: