Article by PharmacyTimes.com
“With the recent expiration of several patents for originator products in oncology and more on the horizon, the biosimilar market is poised for future growth in cancer care. Oncology pharmacists are well positioned to serve as resources for biosimilar use in this setting, whether that be through educating patients and prescribers or helping to lead biosimilar implementation in their institutions.
The International Society of Oncology Pharmacy Practitioners (ISOPP), which met recently for its 18th international symposium on oncology pharmacy practice, issued a new global position statement on the use of oncology biosimilars. The statement covers the regulation and evaluation of biosimilars, practice issues around implementation, education, and the requirement for ongoing pharmacovigilance and outcome monitoring.
Of note, the position statement includes ISOPP’s stance on biosimilar interchangeability, stating that biosimilars are not to be considered interchangeable with an originator product and should not be automatically substituted. Currently, the FDA is the only regulator with the facility to assign an interchangeable designation to a biosimilar. Even so, the agency has not deemed any biosimilar interchangeable to date.
“Given the possible risks associated with transitioning between biotherapeutic products and the absence of an interchangeability designation, automatic substitution with biosimilars is discouraged,” the position states.
However, it does indicate that switching from reference drugs from biosimilars within institutions or for individual patients is acceptable and encouraged.
Furthermore, ISOPP explains that efforts such as formulary addition or the development of treatment protocols to select an institutionally-preferred agent and to switch from an originator to a biosimilar product are strongly encouraged as methods to facilitate biosimilar use.
The position also indicates that ISOPP does not support or recommend the use of biomimics or non-comparable biotherapeutics in practice, reiterating that a biosimilar is not considered therapeutically equivalent to other biosimilars of the same originator.
In addition, the position suggests partial implementation within an institution for certain patient populations, especially when there are financial barriers or clinical issues preventing full implementation.”