A total of 43 biosimilar products are approved in Europe; only 12 biosimilar products are approved in the US. Of these 12, only three are currently on the market. The that biosimilars can reduce US spending by $54 billion between 2017 and 2026; other analysts indicate that biosimilars could reduce Medicare spending by $65 Billion over 10 years. In order for these predictions to be even half-way reachable, biosimilars need to be utilized.
The biosimilar uptake has been less than what the FDA expected. Scott Gottlieb commented at a recent FDA public hearing that he was not satisfied with the current state of the biologics market and biosimilars in particular. The public hearing was held to obtain feedback on an FDA action plan to bring biosimilar products to the market faster so patients can experience the cost savings sooner. Many analysts contend that the US will continue to lag behind Europe in the development and approval of biosimilars as long as the FDA maintains two levels of biosimilars: biosimilar and interchangeable. To date, all of the approved products are approved as “biosimilar,” with no products being approved as “interchangeable.”
In April 2018, ASCO issued aon the utilization of biosimilars in oncology, pointing out that a number of biologic products are scheduled to lose patent by 2020, representing a global market of more than $20 billion. It is expected that biosimilars will take over a majority of this market share. One of the areas that ASCO addresses in the statement is safety and efficacy. ASCO inherently acknowledged the current biosimilar approval process. While not directly stating an opinion on the integrity of the evaluation process, they suggest that oncologists can play a critical role in gathering and reporting post-market experience to enhance patient and provider confidence in biosimilars.
On the topic of interchangeability, ASCO acknowledges that interchangeability designations are determined by the FDA but regulated by the State. Hence, for any product that achieves the “interchangeable” designation, there should be a high level of confidence that the biosimilar product will produce the same clinical benefit. Even with this situation, which has yet to be realized, ASCO is stating that oncologists should be aware of which products are being used on their patients, and that the oncologist should be allowed to make the most appropriate treatment decisions for any particular clinical presentation.
The ASCO statement goes on to address the potential value of biosimilars. They note that while biosimilars present the opportunity for overall cost savings, many other factors must fall into place as well (eg, reasonable compensation, since a contributor to office revenue is the margin made on medications administered in the office). A lower cost product could include smaller margin in the commercial setting. CMS reimbursement methodology is currently the ASP of the individual biosimilars. However, the markup is 6% of the reference product. Other factors include fair and medically appropriate coverage, and transparency of cost to ensure a true value benefit to patients and society and promote access to new and innovative therapies. ASCO ends by re-affirming their commitment to ensure the availability of biologics that are necessary in the delivery of high-quality, high-value care.
As we are starting to see the approval of biosimilars in the oncology space, we need to educate more on the topic of biosimilars in an attempt to boost the confidence level of the evaluation process, thus boosting the confidence level that these products will perform similarly to their reference products. It bears noting that while we are focused on the clinical similarity of the biosimilar, many are quick to forget that even the reference product has batch to batch variations, simply due to the nature of the biologic manufacturing process. Thus far, post-marketing reports published in the rheumatology space find no clinical difference between the reference and biosimilar product. As we continue to grow our understanding of biosimilars, we can increase their utilization and begin to experience the anticipated cost savings.