The increasing global burden of chronic diseases, including cancers, diabetes, autoimmune disorders, anaemia of chronic renal failure, rheumatoid arthritis, multiple sclerosis, blood disorders and others, underscore the importance of patients’ access to safe and effective treatments. Interestingly, the introduction of biologicals in the 1980s revolutionized the treatment of these chronic diseases with better prognosis, although high costs and limited patient access remain challenges. These biologicals are known by various names, including biopharmaceutical agents, biologicals, biological therapies, biological agents and biological response modifier therapy or immunotherapy. Biologicals are derived or manufactured from a living biological system. With the majority of originator biologicals losing patent protection and the emergence of biosimilars, the landscape of biologicals is facing many changes.
A biosimilar, which is also known as a subsequent entry biological, follow-on biological, follow-on protein, generic biopharmaceutical, biogeneric or comparable biological, is a biological medicine that is similar to, but not identical to, an approved originator biological medicine. Unlike chemically synthesized generic small-molecule drugs, biosimilars are complex, large molecule drugs highly similar to, but not identical to, the originator biological. Biosimilars can positively impact the financial sustainability of healthcare systems globally due to their potential for increased patient access to more cost-effective biological alternatives.
Currently, understanding of the nature of originator biologicals and how they relate to their biosimilar alternatives are still challenging for patients, physicians, nurses and other healthcare professionals. Therefore, the author of a published paper [1] believes that pharmacists, especially clinical pharmacists as medication experts, can play critical roles in enhancing the uptake of biosimilars by serving as educators to other pharmacists, physicians, nurses, other healthcare professionals, payers and patients.
As a key member of drug and therapeutic committees, clinical pharmacists can provide leadership in medication management and making formulary decisions about biosimilars. Clinical pharmacists are specifically responsible for the safe storage, dispensing and documentation of biosimilars, as well as for counselling patients. They also consistently engage with patients to confirm adherence to treatment regimens to ensure that patients receive the desired benefits. A clinical pharmacist has the capacity to conduct therapeutic drug monitoring, evaluating patients for efficacy or signs of immunogenicity or toxicity. Clinical pharmacists’ role in changing beliefs, for example, that switching to a biosimilar and indication extrapolation are safe and effective, and behaviours, for example, positive framing of biosimilar conversations with patients, are critical to bringing various stakeholders together to enhance the uptake of biosimilars. Ensuring that a patient receives a biosimilar that is appropriate and aligns with their insurance company’s formulary is another important role for clinical pharmacists that is paramount to guaranteeing access and affordability.
Furthermore, clinical pharmacists can collaborate with pharmaceutical companies to oversee the development and implementation of clinical trials in order to ensure the production of safe and effective biosimilars. Clinical pharmacists are uniquely positioned to be involved in biosimilar application review, which involves clinical judgement when reviewing the totality of evidence such as safety, efficacy and immunogenicity studies presented by the manufacturer to ensure proper utilization. It is noteworthy that the science of biosimilars is complicated and the published literature evolves at a quicker rate than regulatory and policy frameworks. Therefore, it is critical that clinical pharmacists stay up to date on such rapid changes in an evidence-based manner because they are expected to lead discussions with physicians and patients on the interchangeability of originator biologicals with biosimilars.
Finally, despite the fact that the road to biosimilar adoption can be difficult to navigate, clinical pharmacists are well positioned to provide leadership. If clinical pharmacists do not keep up with the changes that biosimilars introduce, the profession may miss out on an opportunity to improve patient care through pharmaceutical care.
Conflict of interest
The author of the research paper [1] declared that there was no conflict of interest.
Abstracted by Dr Roland Nnaemeka Okoro, Department of Clinical Pharmacy and Pharmacy Administration, Faculty of Pharmacy, University of Maiduguri, Nigeria.
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Reference
1. Okoro RN. Biosimilar medicines uptake: The role of the clinical pharmacist. Exploratory Research in Clinical and Social Pharmacy. 2021;1:10008. https://doi.org/10.1016/j.rcsop.2021.100008.
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