Public Health and Nutrition

Most patients still have limited or no access to life-changing therapeutic proteins in the treatment of their cancer or autoimmune

disorders; the current clinical development model of biosimilars is expensive and in most cases large phase 3 trials do not provide meaningful information on the clinical equivalence between biosimilars and reference compounds. At the same time, the development of orthogonal, state of the art analytical methods has enabled a better understanding of the structure and structurefunction

relationship of biotherapeutics. Hence, we suggest here that a solid CMC package, together with meaningful phase 1 studies

will leave limited uncertainty on biosimilarity, that – if needed- can be addressed by post-approval long-term follow-up studies (post-approval studies, pharmacovigilance, Real World Evidence data and registries) ; we believe that this new approach may be more appropriate than 600-1000 patients phase 3 trials in assessing biosimilarity and therapeutic equivalence, under the condition that administered biosimilar given to individual patients can clearly be identified. Obviously, it will probably never be a “one size fits

all” development model and an individualized, risk-based approach to biosimilar developments will always have to be considered

and discussed early with Regulators.