Adoption of Biosimilars in Health Systems Faces Challenges and a Promising Future
The pipeline for biosimilar products in the United States includes at least 26 candidates in phase 3 trials for 13 reference therapies.
The use of biosimilar medications is projected to increase over the next few years. In a session at the virtual Association of Health-System Pharmacists Specialty Conference, presenters provided an overview of biosimilar therapies, discussed a robust pipeline of biosimilar products, and offered strategies for the adoption of biosimilars in health systems.
Biosimilar agents are highly similar to biological reference products that have been approved by the FDA, but demonstrate no clinically meaningful safety, purity, and potency differences, according to presenter Shubha Bhat, PharmD, MS, BCACP, clinical pharmacist, gastroenterology at Cleveland Clinic in Ohio. To date, Bhat said, the FDA has approved a total of 29 biosimilars for 9 reference products, with 68% of these therapies currently available on the market. Additionally, the pipeline for biosimilar products in the United States includes at least 26 candidates in phase 3 trials for 13 reference therapies.
The adoption and integration of biosimilars into the health care system has been slow, according to presenter Isha Rana, PharmD, pharmacy administrative specialist in formulary management and drug information, Houston Methodist, in Texas. In some cases, legal challenges have prevented biosimilars from reaching the market.
Another obstacle for the slow uptake of biosimilars may be a lack of interchangeable products that would allow for substitution at the pharmacy without requiring intervention from a health care professional.
“In practice, what this would look like, is a generic [product] to be substituted in lieu of a branded product, for small molecule entities, without a prescriber’s intervention,” Rana said.
According to Rana, there are no interchangeable biosimilar products currently on the market. However, at least 45 states and Puerto Rico have established standards that either permit or require pharmacists, in certain circumstances, to dispense an interchangeable biosimilar.
“Particularly, if a biosimilar is less costly than another product,” Rana added.
Adoption of biosimilars in a health-system has a number of factors to consider. According to Bhat, following FDA approval, market launch and payer adoption of biosimilars are needed. Other potential barriers for a health-system seeking to adopt biosimilars include establishing a pharmacy and therapeutics process, developing purchasing contracts, ensuring technology infrastructure is in place, obtaining prior authorization support, having supportive state laws, and workflow challenges.
The comfort level and perceptions of both prescribers and patients, as well as prescriber knowledge, can also present challenges for biosimilar adoption in a health-system. According to Bhat, patients have demonstrated concerns for efficacy, safety, co-pays, and clinical stability. She said health-systems can educate patients, promote their involvement in the shared decision-making process, and continue to provide the same standard of care to help overcome perceptions of biosimilars as a barrier.
“Patients are an important stakeholder in the process,” Bhat said.
Furthermore, pharmacists have cited concerns for lack of interchangeability status for biosimilars, as well as availability of biosimilar products, payer restrictions, support services, and clinical evidence. Additionally, safety, ethics, support from national organizations, and clinical evidence were some concerns noted by health care providers.
“It is important to have ongoing education and review literature,” Bhat said.
According to Bhat, providing education, updated literature and position statements, promoting cost savings with biosimilar use, reviewing pharmacovigilance data, and advocating for interchangeability may help health systems overcome pharmacist and provider perception barriers. A streamlined workflow also is key.
Despite the obstacles facing biosimilars, Rana said trends in the United States are promising for these therapies. She noted that biosimilar expenditures have increased dramatically for certain medications, from 2019 to 2020. Noteworthy examples are bevacizumab, for which expenditures increased by 966% over the same year; and trastuzumab, which had an 808% increase in expenditure from 2019 to 2020.
“The US is on track to reduce medication costs by $100 billion over 5 years,” Rana said.
According to Rana, anticipated cost savings will lead to a significant increase in biosimilar product availability and adoption. The United States can also expect to see an expansion of regulatory support that could result in the first interchangeability products coming to the market.
“In the future, we can expect to see more biosimilar options, increased pricing competition, which would accompany that, and also increased market shares of biosimilar uptake as compared to reference product uptake,” Rana said.
Rana I, Bhat S. Managing biosimilars: a specialty all its own. Presented at: American Society of Health-System Pharmacists Specialty Pharmacy Conference; virtual. June 14-16, 2021.