Biosimilar Uptake in Oncology Faces Many Hurdles

Carina Dolan, PharmD, BCOP
Published: Tuesday, Jul 17, 2018
Carina Dolan, PharmD, BCOP

Carina Dolan, PharmD, BCOP

In 2015, the FDA approved the first biosimilar, filgrastim-sndz (Zarxio), under the Biologics Price Competition and Innovation Act of 2009. As of mid-July, 11 biosimilars have received agency approval, including 5 with an oncology indication.1 By January 2018, at least 60 biosimilars were enrolled in the FDA’s biosimilar development program, with FDA commissioner Scott Gottlieb, MD, reporting that the agency had received requests for meetings to discuss biosimilars for 27 distinct reference biologics.2

Most recently, pegfilgrastim-jmdb (Fulphila) was approved by the FDA to decrease the incidence of infection with febrile neutropenia in patients receiving myelosuppressive chemotherapy similar to its reference product. Bevacizumab-awwb (Mvasi), for the treatment of adult patients with certain colorectal, lung, brain, kidney, and cervical cancers; and trastuzumab-dkst (Ogivri), for the treatment of certain breast and stomach cancers, are approved biosimilars that will have the greatest impact in the oncology arena. The expected lower costs of these drugs are likely to increase access to these therapies, which are among the most expensive drugs in the United States and are often out of reach for the patients who need them most.3-5

The successful uptake of biosimilars in the practice of oncology, however, rests on numerous factors, involving clinicians, patients, payers, legislators, and manufacturers. These include the number and timing of entrants into the market; patient and provider acceptability; development costs; competition and litigation involving reference product manufacturers; market size and share; pricing; payer coverage and utilization policies; cost sharing; and regulatory policies around interchangeability (Figure 1).6,7

Clinical and Patient Uptake of Biosimilars

The most important and influential stakeholders for biosimilar acceptance and usage are physicians and patients. However, there is evidence of significant gaps in knowledge for both audiences.

Physician Barriers

A survey of 376 US oncologists (part of a larger survey that included 1245 oncologists total from the United States, Europe, and Latin America) found that they lacked technical knowledge and understanding of the effects of biologics and biosimilars sharing the same nonproprietary name, and misunderstanding if biologics and biosimilars are structurally and therapeutically identical.8 Earlier surveys also found significant knowledge gaps regarding all aspects of biosimilars (chemical structure, difference from reference product, approval process, availability of biosimilars in the United States, etc) among clinicians of various specialties.9-12

Gaining physician support for and confidence in biosimilars will require evidence demonstrating that the biosimilar provides similar efficacy and safety to the reference product. Still, some aspects of the biosimilar concept remain unclear to practitioners surrounding the biosimilar approval process, required clinical trials, and pharmacovigilance. A 2018 statement by the American Society of Clinical Oncology (ASCO) on the appropriate use of biosimilars in clinical practice highlighted the need for postmarketing evidence development to enhance physician and patient confidence in their use. The authors noted that this was particularly important because regulatory review of biosimilars relies less on clinical data and more on structural, functional, and pharmacologic data. ASCO also noted the challenges of such postmarketing evidence, given the fragmentation of the US healthcare system. It suggested that its CancerLinQ database, which provides data on millions of de-identified patients, and the pending FDA surveillance system, Sentinel, designed to monitor safety issues in clinical trials, could be used to collect these data.13

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Online CME Activities
TitleExpiration DateCME Credits
Medical Crossfire®: Addressing Uncertainties in Oncology BiosimilarsApr 30, 20201.5
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