Greater understanding of biosimilars among healthcare providers is key to driving their uptake
Abstract published: August 2021
With a wealth of therapeutic biosimilars on offer for inclusion in formularies, what are the most useful considerations on adopting them into oncology practice?
The Biologics Price Competition and Innovation Act of 2009 (BPCIA) was passed by US Congress to provide an abbreviated approval pathway for biosimilars. Since then, a host of biosimilars have been launched and provide a broad range of options for anticancer treatment – both immunotherapies and targeted agents – and supportive care in oncology.
The total expenditure on novel biologic therapy was estimated at $68 billion in 2020. By contrast, due to their simpler and expedited approval and manufacturing processes, biosimilars are predicted to reduce the total direct cost of biologics by $54 billion over the next 10 years. This reduction will depend on several factors beyond price competition, including confidence in the use of biosimilars among the medical community and their acceptance by patients.
Biosimilar development must include analytical analyses of structure and function and clinical testing, although requisite clinical trials are reduced in number and scope compared with those stipulated for the originator biologic. Clinical similarity studies confirm there are no clinically meaningful differences between the candidate biosimilar and its originator biologic in terms of efficacy, safety, and immunogenicity. Switching studies may also demonstrate interchangeability – evidence that the biosimilar can be prescribed instead of its originator biologic without diminishing its beneficial effects. Once approved for clinical use, biosimilars are subject to strict post-marketing safety monitoring, which must include adequate mechanisms to differentiate adverse events reported for the biosimilar versus reference biologic.
Pharmacy and Therapeutics (P&T) committees must review whether the totality of evidence justifies the indications under formulary consideration. P&T committees should review all data on the sensitive population included in clinical trials of the biosimilar and assess whether they support extrapolation of its use in the intended population. It is important to consider hospital infrastructure in addition to drug acquisition cost – and whether these support full formulary conversion to the biosimilar. Finally, challenges to incorporating biosimilars into practice must be overcome, often necessitating provision of education for healthcare providers as well as patients. Pharmacists play an essential role in helping gain acceptance of biosimilars on formularies and thereby increase treatment options for people with cancer.
Biosimilars must show no clinically meaningful differences between the candidate biosimilar and its originator biologic in terms of efficacy, safety, and immunogenicity, and are subject to strict post-marketing safety monitoring. Challenges to uptake of biosimilars include drug cost and infrastructure cost, as well as healthcare professional and patient education.