生物等效性和生物利用度杂志

抽象的

Policy Practices to Maximise Social Benefit from Biosimilars

Inotai A, Csanádi M, Vitezic D, Francetic I, Tesar T, Bochenek T, Lorenzovici L, Dylst P and Kaló Z

Biosimilar medicines can generate savings to the society. However, if patient access to original biologic medicines is limited, the main benefit of biosimilar medicines is to treat more patients from the same health care budget and hence generate more health gain.

The aim of this policy paper is to provide recommendations on how to maximise the value proposition of biosimilar medicines in lower income countries with more limited health care resources.

From the clinical perspective, first line use of multi-source, off-patent biologics should be considered for all treatment naïve patients before prescribing any other patented biologic therapies without major added benefit. Systematic literature reviews indicate that significant and quantifiable economic benefits from switching patients on maintenance biologic to biosimilars should not be sacrificed for non-quantifiable and fairly low risks of immunogenicity, hence a single switch of patients from an original biologic to its biosimilar alternative under medical supervision should be mandated after patent expiry.

From the health economic perspective authors advocate the use of cost-utility analysis to evaluate the full economic value of biosimilars. In sensitivity analyses decision-makers can explore the level of risk associated with immunogenicity, where switch of patients treated by original biologics is not the preferred policy approach anymore. However, authors still advocate the collection of real world pharmacovigilance data after switching patients to biosimilars, and reassessment of cost-effectiveness ratio after more real-world data becomes available.

Appropriateness of biosimilar drug policies is equally important to market access of new biologic therapies in lower income countries.