4
Biosimilars
➤ Biosimilars must be approved through a robust regulatory review.
"Biomimics" or "intended copies" are not biosimilars. This may
require ongoing education for both patients and clinicians' education
to ensure a thorough understanding.
➤ Periodic re-evaluation of biosimilar products after their initial
approval would be important to ensure ongoing quality.
➤ Extrapolation to PsA, even when no studies of a given biosimilar
were conducted in PsA, is acceptable. Ideally, additional studies
specifically in PsA can be conducted if they were not part of the initial
approval process.
➤ Patients and clinicians must be involved in decisions about switching.
➤ Pharmacovigilance is crucial; naming conventions need to allow
tracking of specific agents and batches.
➤ Multiple switches need to be studied in a rigorous fashion on an
ongoing basis.
➤ Savings realized from the use of biosimilars should be utilized to
improve access for larger numbers of patients.
➤ Immunogenicity is a potential concern that should be monitored on an
ongoing basis.
Treatment
