On Saturday, U.S. patient advocacy groups and insurance industry leaders urged Congress to eliminate interchangeability regulations for biosimilars. They argued that the current system is inefficient and that regulatory relief is crucial to improve patient access to treatments. If these demands are met, Korean pharmaceutical giants like Celltrion and Samsung Bioepis could see significant reductions in clinical development costs for biosimilars.
The Association for Accessible Medicines (AAM) and the Biosimilars Council recently sent a joint letter to the leadership of the Senate Health Committee and the House Energy and Commerce Committee, calling for swift action on the “Biosimilar Red Tape Elimination Act.” This follows an initial appeal made last July.
More than 40 local organizations have endorsed the red-tape removal bill. This unusual alliance between patient groups and insurers, often at odds over drug pricing, signals a united front for regulatory reform.
The letter bore signatures from major players in the U.S. healthcare system, including the American Health Insurance Plans (AHIP), the Blue Cross Blue Shield Association (BCBS), and CVS Health.
Patient advocacy groups like the National Patient Advocate Foundation and the National Consumers League, along with policy watchdogs such as the Taxpayer Protection Alliance, also joined the effort.
They criticized current laws that artificially distinguish between biosimilars and interchangeable biosimilars, arguing that this fuels unfounded concerns about drug safety.
The groups stressed that these unnecessary barriers limit patient access to vital medications and drive up healthcare costs nationwide, calling for immediate legislative action.
The U.S. Food and Drug Administration (FDA) has aligned itself with industry perspectives. FDA Commissioner Dr. Marty Makary dismissed the interchangeability designation as a mere administrative procedure for pharmacy substitution, not a reflection of differences in quality or efficacy.
AAM President John Murphy emphasized that interchangeability is a regulatory construct based on legislative language, with no parallel in other countries. In pharmaceutical powerhouses like those in Europe, biosimilars are treated on par with original drugs without separate interchangeability certifications.
The AAM and Biosimilars Council report that since their 2015 debut, biosimilars have saved the U.S. healthcare system over $56 billion.
Moreover, over the past decade, biosimilars have shown no clinically significant differences in safety or efficacy compared to their reference products.
Alex Keaton, a director at the Biosimilars Council, stated that biosimilar competition has expanded treatment options for patients. Passing the red tape removal bill will clear market confusion, streamline approvals, and make essential medications more affordable.
Relaxing interchangeability regulations could be a boon for Korean pharmaceutical companies eyeing the U.S. biosimilar market. Industry leaders like Samsung Bioepis and Celltrion have invested heavily to secure interchangeable biosimilar status.
Under current rules, for a biosimilar to be automatically substituted for the original drug, companies must conduct additional, costly interchangeability trials beyond standard approval studies. This has effectively served as a trade barrier.
If the bill passes, these extra hurdles could disappear, allowing Korean firms to compete directly with original drugs based solely on FDA approval, without the burden of additional clinical costs.
This could be a game-changer for companies like Celltrion, with its strong direct sales capabilities, and Samsung Bioepis, which is diversifying its product portfolio, potentially boosting its market share significantly.
An industry insider noted that while the current regulations can enhance competitiveness for companies that achieve interchangeability, their removal would reduce costs and offer distinct advantages.
They added that this push isn’t just about cutting red tape; it’s about addressing the underutilization of biosimilars in the market despite their proven benefits.