ASCO Recommendations for Biosimilars in Oncology: Enhancing Awareness, Addressing Barriers, and Ensuring Patient Access

A policy statement from ASCO (American Society of Clinical Oncology Practice) on biosimilars in oncology highlights the increasing number of approved biosimilar products and proposes policy recommendations to address value, interchangeability, clinician barriers, and patient education and access, reaffirming ASCO's commitment to educating the oncology community on the use of biosimilars in cancer care. 

The slow adoption of oncology biosimilars in the US market can be attributed to a limited understanding of the manufacturing and preapproval process, concerns regarding long-term safety and efficacy, variability in product quality over time, substitution practices, lack of clarity on interchangeability, and tactics used by nonbiosimilar drug manufacturers to delay market entry. As a result, biosimilars for cancer treatment have gained less market share than generic drugs, which typically achieve around 75%-90% market share within the first two years of approval.  

The FDA has approved 40 biosimilars as of February 9, 2022, with the first oncology biosimilar being used in supportive care in 2015. Currently, there are 12 agents approved for cancer treatment and 10 for supportive care. In the European Union, the first biosimilar was approved in 2006, and the European Medicines Agency (EMA) has since approved 99 biosimilars in various therapeutic areas. The use of biosimilars in Europe has resulted in significant cost savings compared to the reference products. However, more research is needed to determine the cost-effectiveness of biosimilars, including the indirect costs associated with their use. 

In 2022, the FDA launched a biosimilar regulatory science program to advance biosimilar and interchangeable biological product development. Despite the FDA's efforts, confusion and misinformation still exist regarding the interchangeability of biosimilars. To be approved as interchangeable, a biosimilar must demonstrate the same clinical result and no additional risks compared to the reference product and this distinction at the pharmacy level adds to the confusion and barriers in education and patient access, further compounded by varying state pharmacy laws.  

Currently, there are no FDA-approved interchangeable products in oncology, and only a few have been approved for certain diseases. Clinicians are recommended to review approved biosimilars with their drug committees to determine their appropriateness and cost-effectiveness for their patients. 

The value of biosimilars in cancer care is determined by the cost of the product and the benefits it provides to patients. Studies have estimated that the introduction of biosimilars could reduce health care costs by 15%-30%, with potential savings ranging from 8.1% to 48.3%. Savings to the US health care system from the use of biosimilars are projected to be billions of dollars over the next decade. However, the realization of these savings depends on factors such as competition, availability, and willingness to use biosimilars. Additionally, value assessment frameworks and value-based care programs are being developed to improve cost-effectiveness and ensure patient access to high-quality care. 

ASCO has taken steps to educate clinicians about biosimilars through educational programs and publications, but there are still barriers to their uptake and utilization in clinical practice. Clinicians must consider various factors when contemplating the use of biosimilars, including the different regulatory processes, terminology, and safety concerns. Explaining these complex issues to patients can be challenging, especially when multiple biosimilars are available within the same drug class. Clinicians also face challenges related to payer and PBM policies, including the cost of acquisition, additional storage requirements, and administrative burden. Business agreements and tactics employed by pharmaceutical manufacturers further slow down the uptake of biosimilars in the market. Ultimately, clinician comfort with biosimilar utilization depends on evidence of safety and efficacy, integration into clinical practice guidelines, and consistent coverage and reimbursement policies. 

Discussing biosimilars as an alternative treatment is often challenging due to factors like health care professionals' lack of understanding and confidence in biosimilars, as well as decisions made by PBMs, payers, and administrators that are beyond their control. A recent survey revealed a gap between oncologists' and patients' perceptions of communication, with a smaller percentage of patients feeling adequately informed about switching to a biosimilar than oncologists believed. Therefore, oncology teams need to coordinate efforts to ensure patients receive sufficient resources to understand their treatments. 

“To reach the potential value and cost savings that biosimilars offer, it is important to involve all stakeholders, including manufacturers, payers, PBMs, regulatory agencies, clinicians, and patients,” said researchers. “Total stakeholder input is needed to establish a deliberate process to address many of the challenges to biosimilar uptake: formulary exclusions, operational barriers, and unclear guidelines for biosimilar implementation.”  

High drug prices can create financial barriers for patients and the health care system, leading to restricted access to essential therapies and noncompliance with medication. The IRA law signed in 2022 aims to address this issue by allowing CMS to negotiate lower drug prices in the Medicare program. However, the impact of this policy and the acceptance of biosimilars among clinicians and patients still need to be monitored and improved through effective communication and education. 

Reference 

Rodriguez G, Mancuso J, Lyman GH, et al. ASCO policy statement on biosimilar and interchangeable products in oncology. JCO Oncology Practice. 2023;19(7):411-419.