Biosimilar Briefs: When to Switch to Biosimilars and More

October 30, 2021

An Emory pharmacy expert talks about the timing of switching to biosimliars, the Biosimilars Forum recommends biosimilars incentives, and Samsung Bioepis reaches a milestone.

Who Is Best Suited for Biosimilars?

The patients best suited for biosimilars are the ones facing financial toxicity, whose copays are difficult to manage, Ryan Haumschild, PharmD, MS, MBA, explains in a video interview with The American Journal of Managed Care^®. Haumschild is director of pharmacy at the Emory Healthcare and Winship Cancer Institute in Atlanta, Georgia, and a member of the advisory board of The Center for Biosimilars®.

Haumschild also addresses the timing for switching patients to biosimilars. Patients who are stable on reference products should be considered in a different light from patients who are biologic treatment naïve. “There are a lot of clinical considerations, and there’s not a one-size-fits-all approach,” he says.

Tune in for the full interview here.

Samsung Bioepis Wraps Up Eculizumab Biosimilar Trial

Samsung Bioepis reported completion of a phase 3 clinical trial of a biosimilar candidate to eculizumab (referencing Soliris). The study randomized patients with paroxysmal nocturnal hemoglobinuria (PNH) to initial treatment with the biosimilar candidate (SB12) and the reference product. At 26 weeks, patients on SB12 were switched to the reference product and those on the reference product were switched to SB12.

The 2-year study enrolled 50 patients across 27 clinical sites in 8 countries. Efficacy, safety, pharmacokinetics, and immunogenicity of the biosimilar candidate were evaluated in this trial. Findings have yet to be released.

PNH is a rare, acquired condition characterized by the destruction of red blood cells, blood clots, and impaired bone marrow function, or inability to produce sufficient quantities of blood components. Although this disease occurs in 1 to 1.5 individuals per million, the incidence rises to 20% to 30% for patients with aplastic anemia treated with immunosuppressive therapy. Similar to PNH, aplastic anemia involves failure to produce enough red blood cells.

The trial began in August 2019, and expansion of the phase 3 study to sites in China was approved by the National Medical Products Administration in January 2020.

Biosimilars Forum and the “Build Back Better Act”

The Biosimilars Forum, a trade group of biosimilar manufacturers and developers, has petitioned members of Congress to include incentives for biosimilar use in the Build Back Better Act, a Democratic initiative to improve education, child care, labor conditions, health care, taxes, immigration policy, and the environment.

The $1.5 trillion-plus spending plan would require HHS to negotiate maximum prices for certain brand-name drugs under Medicare, among other provisions. The Biosimilars Forum has asked for an increase in Medicare reimbursement for physicians who prescribe biosimilars. Currently, physicians receive 6% of the average sales price of the reference drug when they prescribe a biosimilar. The Biosimilars Forum wants that increased to 8%, with savings from biosimilar use shared with physicians.

The group also called for reductions in patient out-of-pocket costs when biosimilars are employed and suggested including biosimilar use in the Medicare Advantage and Part D Star Ratings systems, which are used to evaluate the performance of plan benefit and formulary designs.

“Unlike generic drugs, which are available to 90% of patients, biosimilars are only available to 20% of the patients who need them. This must change if patients are to realize the full savings potential of biosimilars,” the group said in a statement.

Recently, President Joe Biden called upon HHS to develop policy guidance that would lead to lower drug prices for biologics and other drugs. As a result of an executive order in July, CMS could move forward with a plan to negotiate drug prices to achieve savings, and Biden’s executive order also encompasses the potential for experimental consolidation of billing codes under Medicare Part B. This would enable CMS to issue a common billing code within therapeutic areas for biosimilars and their respective reference products and pay providers and health care institutions identical amounts for drugs within a class of products, such as trastuzumab.

The Medicare Payment Advisory Commission has stated that this could help stimulate biosimilar use through lower prices, although some in the health care industry have countered that it would pull the price floor out from under biologics and force some to produce at very low rates of return or at a loss, leading to producers exiting the market.