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Introduction

Since their introduction almost 40 years ago, biopharmaceuticals, also known as “biologics,” have revolutionized oncology practice, offering new approaches and strategies to treat both the underlying disease processes as well the secondary side effects associated with the use of cancer drugs.¹ Unlike chemically synthesized small molecules, which are less than 1000 Da in size and relatively easy to synthesize and characterize, biologics are generated from the cells of living organisms, such as viruses, bacteria, and eukaryotic cells, using complex and heterogeneous processes involving recombinant DNA technology or controlled gene expression.² As a consequence, even the smallest alteration in the manufacturing process, storage, or handling of biologic drugs can have serious ramifications on their efficacy and safety.

Today, the United States (US) has the largest market for biologics in the world, accounting for nearly 50% of all prescription drug expenditures; it also is the nation’s fastest growing pharmaceutical sector.³ More than 80% of the revenue from biologic therapy is derived from oncology indications, and this percentage is expected to increase in the coming years as the incidence of cancer continues to rise and the use of these essential drugs expands in clinics and oncology centers. These trends are not limited to the US, although the increases are not as great; still, the global biologic therapy market is expected to top $100 billion by 2023.⁴

The high cost of biologic therapies has been a considerable financial drain on commercial insurers and corporate payers, the federal government, and those with individual coverage. The 2017 expenditures for the 5 most costly biologics – infliximab, pegfilgrastim, rituximab, nivolumab, and bevacizumab – range from $2.3 to $3.7 million each, a growth rate for each, relative to 2016, of about 2% to 22% (only bevacizumab showed a decrease, 3.3%).⁵ Patent exclusivity for many biologics has expired, which has opened the search for more cost-effective alternatives such as biosimilars. Although they are often described as generic versions of biologic molecules, biosimilars are a distinct drug category. Whereas traditional generic drugs are identical copies of the original, biosimilars are highly similar, but not exact, versions of the reference agent. As a result, there are “no clinically meaningful differences between the [biosimilar drug] and the reference product in terms of safety, purity, and potency,” even if minor distinctions in, for instance, the inactive components are present.⁶

Thus, the availability of effective and safe biosimilar drugs could be a boon to healthcare delivery, reducing costs, increasing access, and generally improving clinical outcomes for cancer patients. In fact, the Biologics Price Competition and Innovation Act of 2009, the legislation that created an abbreviated pathway to approval for biosimilar drugs, was purposely designed to increase competition with reference biologics in order to lower process and accelerate innovation.⁷ One estimate suggests that switching to biosimilars could save between $40 and $250 billion over the next 10 years.⁸ As of late 2019, several dozen biosimilars have been approved in the US as potential substitutes for such noteworthy reference biologics as trastuzumab (eg, trastuzumab-qvvp, trastuzumab-dkst, trastuzumab-pkrb, and trastuzumab-dttb), bevacizumab (bevacizumab-awwb and bevacizumab-bvzr), and filgrastim (filgrastim-sndz and filgrastim-aafi) (Table 1).^9-10

However, the uptake of these new agents remains less than optimum. Despite their myriad potential advantages to foster value-oriented, patient-centered cancer care, healthcare professionals and patients remain skeptical about their therapeutic value, questioning their efficacy and safety.¹⁰ In addition, the use of biosimilars raises a number of profound formulary management questions for oncology pharmacists. In the coming years, pharmacists, working with other providers and patients, will be required to play a leading part in the evaluation of biosimilar agents, especially concerning the legal requirements for substitution and interchangeability, pharmacovigilance, patient education, medication reconciliation, the transition of care, and inventory management.

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