Ali McBride, PharmD, MS, BCOP, FASHP, FAzPA, clinical coordinator, Hematology/Oncology, The University of Arizona Cancer Center, clinical assistant professor, The University of Arizona College of Pharmacy, discusses the potential utility of biosimilars in oncology.

There are several biosimilars for originator drugs, including rituximab (Rituxan), trastuzumab (Herceptin), and bevacizumab (Avastin). Biosimilars are large, complex molecules that are structurally similar to originator molecules but not exact due to post-translational modifications of the drug’s protein structure, says McBride.

The agents are thoroughly investigated in the preclinical setting and subject to clinical evaluation. Biosimilars are able to be manufactured at lower prices because they are not subject to the extensive clinical trial process investigational agents are, says McBride.

As such, biosimilars may be more affordable and accessible to patients. Payers will largely control the outpatientuse of biosimilars; however, multiple agents are approved and will infiltrate the oncology space shortly, McBride concludes.

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Ali McBride, PharmD, MS, BCOP, FASHP, FAzPA, discusses the potential utility of biosimilars in oncology.

Dr. McBride on the Potential of Biosimilars in Oncology

Ali McBride, PharmD, MS, BCOP, FASHP, FAzPA, clinical coordinator, Hematology/Oncology, The University of Arizona Cancer Center, clinical assistant professor, The University of Arizona College of Pharmacy, discusses the regulatory pathway for biosimilars in oncology.

Biosimilars have led to the development of a new regulatory pathway for biologics, says McBride. In the past, generics, apart from brand name drugs, were the only agents that had an established system of regulation. Prior to the Hatch-Waxman Act, there were no generics for biosimilars because there was no pathway, says McBride.

Similarly, prior to the Affordable Care Act (ACA), there was no pathway that defined what a biosimilar was and what criteria should warrant an approval. Since the ACA was established, the FDA has established regulatory guidance regarding interpretations of immunogenicity and interchangeability that have led a number of approved biosimilars, concludes McBride.

Dr. McBride on the Regulatory Pathway for Biosimilars in Oncology

Ali McBride, PharmD, MS, BCOP, FASHP, FAzPA, clinical coordinator, Hematology/Oncology, The University of Arizona Cancer Center, clinical assistant professor, The University of Arizona College of Pharmacy, discusses factors that need to be taken into consideration as biosimilars emerge in oncology.

Biosimilars have been slowly evolving in the market, but McBride believes 2020 will be the “year of the biosimilar.” Many drug therapies have gotten approved; however, they are on hold due to patent litigation. Next year, McBride anticipates seeing a flood of therapeutic biosimilars in the oncology market.

There are many factors to consider with the emergence of biosimilars, including how biosimilars will interplay with care in community oncology—based facilities, academic facilities, and large integrated delivery systems, explains McBride. Additionally, a facility’s finances, formulary, and electronic health records need to be examined as biosimilars become more common. Patients and physicians should be educated about the use of biosimilars. Facilities need to consider how to enroll patients into programs for biosimilars and how financial advocates will address biosimilars, concludes McBride.

Ali McBride, PharmD, MS, BCOP, FASHP, FAzPA, discusses factors that need to be taken into consideration as biosimilars emerge in oncology.

Ali McBride, PharmD, MS, BCOP, FASHP, FAzPA

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Dr. McBride on the Potential of Biosimilars in Oncology

Dr. McBride on the Regulatory Pathway for Biosimilars in Oncology

Dr. McBride on the Emergence of Biosimilars in Oncology