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the reference product . Likewise , physicians might be reluctant to switch to a biosimilar in the midst of active cancer therapy simply to achieve cost savings for fear of possible litigation , especially as they retain clinical responsibility for the patient , despite evidence that switching does not adversely affect outcomes . 20 Removing the barrier imposed by the FDA designated interchangeable status of a biosimilar , especially given that the majority of US states having passed legislation to facilitate substitution by pharmacists , would likely allow for the full economic benefit of biosimilars to be realized . A further measure would be inclusion of biosimilars in official treatment guidelines to enhance physician acceptance of these drugs .
Utilization of biosimilar manufacturer-sponsored support service programs directed at both physicians and patients will hopefully diminish the knowledgerelated adoption barriers . As discussed above , patient education programs that offer reassurance on the efficacy and safety of biosimilars and how these drugs have the potential to both reduce costs and increase access to treatment are therefore a crucial step in gaining patient acceptance and reducing the nocebo effect . If a biosimilar manufacturer can assist in the establishment of an ongoing pharmacovigilance program capturing realworld data , this would offer some assurance on the long-term safety of biosimilars . Furthermore , greater data sharing of experience with European colleagues might help to increase uptake .
Changes to the reimbursement of drugs remains an important barrier to adoption but it seems that the US administration is taking steps to redress this problem . Policy changes already allow biosimilars to be treated as biologics within the Medicare coverage gap , without which clinicians would be more likely to use the reference product . Greater exclusion of reference products for coverage by various pharmacy benefit managers and payers could lead to increased biosimilar uptake . 21
Conclusions The cost savings achieved in the EU through adoption of biosimilars have yet to be realized in the US . Although over time , and with the appropriate education , US health care providers will become more accepting of and confident in using biosimilars , the current US commercial market is still driven by confidential rebate agreements with manufacturers that help maintain profitability . It is only when rebates become more transparent that the market will become more accepting of biosimilars , allowing patients to achieve more equitable access to oncology treatments .
SCIENCE PHOTO LIBRARY
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