Biosimilars are beginning to permeate the U.S. oncology market, but the floodgates aren’t exactly open. Despite their promise to expand treatment options and rein in cancer costs, biosimilars continue to face prescriber inexperience and other challenges that affect adoption levels. To execute an effective go-to-market strategy in the evolving cancer landscape, biosimilar manufacturers must contend with increasing competition, overcome patent disputes, and develop education programs for biosimilar-naïve stakeholders. Meanwhile, manufacturers of originator products will need to develop effective defense strategies in anticipation of biosimilar competition.
A panel of industry experts, including ZS’s Christina Corridon, an associate principal and leader in the biosimilar center of excellence within the oncology practice area, participated in an OBR-hosted webinar on July 27, 2017, to discuss the changing role of payers, providers and manufacturers related to the adoption of oncology biosimilars. Corridon was joined by webinar moderator Don Sharpe, president of OBR; Howard Hochster, M.D., professor of medicine and associate director of clinical services at Yale Cancer Center; and Steven B. Miller, M.D., senior vice president and chief medical officer at Express Scripts.
Following a discussion of recently approved oncology biosimilars, the difference between biosimilars and generics, potential cost savings and market dynamics influencing category expansion, Corridon shared a few observations with the group from a ZS survey of 252 oncologists, payers and pharmacy directors, whom ZS polled to represent the stakeholders driving the adoption of biosimilars.
“The tidal wave of activity presents many opportunities, but depending on your perspective, it may also be a little daunting to surf into this,” Corridon said. According to ZS’s survey, there are four key factors that are affecting the U.S. adoption of biosimilars:
- Industry stakeholders have a limited understanding of biosimilars. The research revealed a correlation between a stakeholder’s education level regarding oncology biosimilars and her willingness to try and potentially adopt them. Dr. Hochster explained that oncologists’ knowledge of biosimilars is “pretty minimal,” and indicated a need to educate more broadly on the concepts of biosimilarity, interchangeability and switching.
- Oncologists need to be confident that biosimilars are on par with the reference products. Biosimilars must prove that they meet a certain level of criteria already established by the reference products. Surveyed oncologists identified the following adoption drivers:
- Favorable cost: The market expects to see considerable savings with biosimilar entry, not just from the biosimilars themselves but also from enhanced competition driving down the prices of originator products. In fact, Miller identified the financial piece as the biggest reason that the industry is focused on the adoption of therapeutic oncology biosimilars, adding that they’re “safe, effective and more affordable [than originator products].”
- Ease of reimbursement: Oncologists need easy access to the products that they intend to prescribe.
- Guidelines: Biosimilar guidelines need to meet the standards already established by the reference products in the same category and therapeutic area.
- Manufacturer brand: In some cases, oncologists may prefer to prescribe one brand over another either because of prior experiences or based on the manufacturer’s reputation.
- Half of the oncologists surveyed are prepared to use biosimilars. The survey found that nearly 50% of oncologists are ready to adopt biosimilars at FDA approval, and showed no indication of discrimination based on tumor type. Conversely, about one-fifth of participating oncologists indicated that they would prescribe biosimilars only when the practice or payer forced their adoption. The EMR in Dr. Hochster’s practice, for example, restricts his ability to prescribe the originator product to biosimilar white cell stimulator Zarxio.
- Oncologists are more hesitant to switch patients to biosimilars. Oncologists are more likely to prescribe a biosimilar to a new patient or to a patient not already on a branded biologic than they are to switch a patient from the reference product to a biosimilar. Oncologists’ hesitation to prescribe likely results from safety and efficacy concerns, but as both Dr. Hochster and Miller pointed out, originator products also vary slightly from one batch to the next, and biosimilars fall within the same range of variability. In fact, the ZS survey found that a poor understanding of the manufacturing process is one example of an educational gap that, if closed, could improve biosimilar adoption rates.
According to Dr. Hochster, ignorance is the biggest barrier that biosimilars will face, and physicians need to be comfortable with the concept that biosimilars are going to be just as good for the patient as the originator molecule, and they’ll come at a lower price. Moreover, Miller said that biosimilars will continue to face stiff competition because originators will do everything in their power to maintain market share, such as by bundling products together and offering discounts. Lastly, Corridon questioned whether the biosimilar landscape will be financially sustainable for certain entrants.