Examining Barriers to Biosimilar Adoption in Clinical Practice

A research summary published in Clinical Pharmacology and Therapeutics explores the experiences and perspectives of academic clinicians on increasing biosimilar adoption, emphasizing the need for education and systemic changes in pricing and reimbursement to improve acceptance among providers and patients. 

The Biologics Price Competition and Innovation Act (BPCI) of 2009 established a pathway for the approval of biosimilar and interchangeable biologic products in the US, defining a biosimilar as highly similar to the reference product. The FDA supports the interchangeable designation by satisfying additional safety standards to enhance patient access to competitive biosimilars. 

The adoption of biosimilars varies depending on the product class and the time since its market launch. In September 2021, biosimilar market share ranged from 3% to 89% across different products. In rheumatology, the market share of biosimilars was around 32% for rituximab and infliximab combined, indicating slow but growing adoption by rheumatologists. 

Biologics make up just 2% of all prescriptions in the US but account for 43% of medicine spending, reaching $211 billion in 2019. Oncology products are particularly affected by the high cost of biologics, with 6 of the 10 most costly biologics covered under Medicare Part B being oncology products. 

The challenges for biosimilar adoption include reduced commercial availability due to time‐consuming patent dispute resolution processes, where innovator biologic manufacturers use patent infringement litigation to delay the marketing of recently approved biosimilars. This can result in delayed launches and prolonged patent disputes. Additionally, prescribers' lack of familiarity with biosimilar development and regulatory standards contributes to concerns over the efficacy and safety of biosimilars, leading to slower adoption and reluctance to prescribe certain indications without clinical evaluation. 

Other barriers to adoption include concerns about potential immunogenicity impact on clinical outcomes, the administrative burden of biosimilar prescriptions, substitution without provider intervention, and a lack of incentive for clinicians to prescribe biosimilars. The need for individualized insulin dosing and patient interactions with insulin delivery devices are barriers specific to the adoption of biosimilar insulin products. Insulin dosing must be tailored to each patient's individual needs, and the patient's interaction with the delivery device plays a crucial role in adherence, safety, and effectiveness. 

The potential drivers of biosimilar adoption include health care provider education and integration into clinical practice guidelines. Education efforts by organizations like the FDA and clinical societies have shown to be impactful in addressing concerns about biosimilar safety and efficacy. Communications from clinical societies, such as the American Society of Clinical Oncology and rheumatology societies, and their integration of biosimilars into guidelines have also played a role in promoting adoption. Enhanced patient-provider communication and shared decision-making have been identified as important factors in overcoming barriers to biosimilar adoption, especially in managing conditions like diabetes and inflammatory bowel disease. Additionally, the availability of post-market surveillance and real-world data on the efficacy and safety of biosimilars, collected through registries and studies, addresses concerns about extrapolation and switching from innovator biologics. 

The introduction of biosimilars has the potential to result in significant cost savings on biological products. However, the main driver of these cost savings is expected to be the downward pressure on prices of the original innovator products rather than the lower prices of biosimilars. So far, the uptake of biosimilars has been slow and gradual, mostly influenced by payers rather than clinicians and patients.  

Efforts should be made to address the concerns of treating physicians regarding the response of patients to new devices used for administering biosimilars, and to ensure proper training of patients in using these devices. Non-medical switching of stable patients to a different agent is a major concern for clinicians and patients, who prefer to make treatment decisions themselves. Concerns about the efficacy of biosimilars due to limited pre-market clinical data continue to influence prescribers' decisions. In the field of oncology, doubts about efficacy explain the hesitancy of clinicians to prescribe biosimilars for curative purposes, while the uptake for supportive care has been more rapid.  

The lack of incentive for providers to prescribe biosimilars due to limited cost benefits for insured patients is a structural issue that needs to be addressed by manufacturers, payers, and government. Other barriers to biosimilar adoption can be addressed through education targeting health care providers and patients. Clinical pharmacology has a role in educating providers about the scientific evidence supporting biosimilar approval, while patients need to be educated on biosimilars, proper device use, and the management of potential negative effects. 

Efforts should also focus on educating advanced practice providers who have limited experience with prescribing biosimilars. Regulatory bodies, clinical societies, and patient associations can contribute to the development of educational tools aimed at promoting the high regulatory standards of biosimilars and the benefits they offer to health care systems. 

Reference 

Shubow S, Sun Q, Nguyen Phan AL, et al. Prescriber perspectives on biosimilar adoption and potential role of clinical pharmacology: A workshop summary. Clinical Pharmacology and Therapeutics. 2023;113(1), 37–49. doi:10.1002/cpt.2765