Despite Some Obstacles, Biosimilars Promise Enormous Cost Savings

As biosimilar approvals and implementation continue to accelerate, the US health care system can expect to see enormous cost benefits if payers challenges and other questions are addressed, according to an expert at the American Society of Health-System Pharmacists (ASHP) 2022 Midyear Clinical Meeting.

Biologics have revolutionized treatments for serious health conditions over the past 30 years, according to presenter Jorge J. Garcia, PharmD, MS, MHA, MBA, FACHE. The 1980s saw the rise of cloning, gene expression technology, and increasingly complex molecules, but all of these innovations and transformations also resulted in significant costs to health systems. Biologics net spending reached $211 billion in 2019 and has increased at a 14.6% compound annual growth rate over the past 5 years.

Importantly, patent expiration has brought new companies and products to the space and biosimilars are expected to assume the majority of the market share. Garcia noted that although biologics are a massive source of health care costs, they are a very small percentage of prescriptions.

“When we connect these charts, what we see is that 2% of biologic prescriptions are driving close to 50% of the cost,” Garcia said.

The biosimilar manufacturing process has several key differences to other manufacturing processes, particularly the fact that biosimilars must have amino acid sequences that are the same as those in the reference drug; however, they may have minor differences. Molecular variability “drift” can occur and is primarily due to changes in the manufacturing process rather than the result of error. Garcia noted that these are largely accepted by regulatory entities without new clinical trials, and there are processes in place to monitor drift over time.

Immunogenicity is highly contested in biosimilars. Two molecule immunogenicity reports in the European Union showed 95% confirmed similarity and 5% exhibited immunogenicity clinical differences.

However, these differences were mitigated by changes in the manufacturing process. Both instances of differences occurred in 2010 and re-occurrence is unlikely given advances in assays and improved process controls, Garcia said.

The recent FDA approval of insulin glargine-yfgn (Semglee, Viatris) presents several key advancements in the interchangeability space due to its approval with the first FDA interchangeability designation. Because of its role in the diabetes space, insulin glargine-yfgn has the ability to reach a massive patient population. Notably, it is also the first biosimilar to have part D pharmacy benefits and to operate in the community pharmacy space.

Looking to the future, Garcia said he anticipates the biosimilar space to continue expanding rapidly. Annual approvals peaked in 2019 with 10 biosimilar approvals, followed by a sharp decline in 2020 and 2021 due to the pandemic. However, 5 biosimilars have already been approved in 2022, suggesting that the trend is increasing once again.

Importantly, the American Society of Clinical Oncology and National Comprehensive Cancer Network have also released guidelines endorsing biosimilars, which Garcia said is encouraging.

“This was really great to see and was really aspirational just a couple years ago,” he said.

Finally, Garcia said getting payers on board will be key to national biosimilar cost-savings potential. Medicare, Medicaid, and commercial payers have all approached biosimilar reimbursement differently, but increasing the number of licensed biosimilars to increase market competition will reduce biosimilar and biologic drug cost, according to Garcia.

REFERENCE

Garcia JJ. Biosimilars Implementation in the United States; A Five-Year Review. Presented at ASHP 2022 Midyear Clinical Meeting. December 5, 2022.