The United States is accelerating reforms to expand competition in the biosimilars market. Following the Senate's passage of a bill aimed at lowering patent barriers and streamlining interchangeability recognition procedures, domestic companies like Celltrion and Samsung Bioepis are increasingly optimistic about the potential benefits.
According to the Korea Bio Association's Bioeconomy Research Center, the U.S. Senate passed the "Affordable Prescriptions for Patients Act" on July 21, which limits the construction of patent thickets by original drug manufacturers. The accompanying "Biosimilar Regulatory Easing Act" recognizes biosimilars approved by the U.S. Food and Drug Administration (FDA) as interchangeable products without the need for cross-dosing.
This legislation focuses on curbing the patent abuse by original pharmaceutical companies. The industry has previously utilized a strategy of registering additional patents related to formulations and administration methods to delay competitors' market entry. Under the new law, the number of patents that can be asserted in lawsuits against biosimilar developers will be capped at 20.
According to the "U.S. Biosimilar Regulatory Changes and Global Market Outlook" report by the Biosimilars Association, existing approved products will be recognized as interchangeable after a 60-day transition period once the law is enacted. Interchangeability is a system that allows pharmacies to substitute biosimilars for original drugs. Previously, this required additional clinical burdens.
Among domestic companies, Celltrion and Samsung Bioepis are highlighted as key beneficiaries. With the recognition of interchangeability, industry experts believe that their products will gain significant competitive advantages in the distribution market, including with pharmacy benefit managers (PBMs).
Celltrion currently holds five products with interchangeability approval. Its rituximab biosimilar, Truxima, recently became the first product in its category to obtain FDA interchangeability status, securing exclusive rights as the first interchangeable biosimilar. As of this month, Truxima has maintained a 38.6% market share in the U.S., ranking first for four consecutive months.
Samsung Bioepis has a total of eight products with interchangeability approval, including two versions of SB16. Last year, its Prolia and Xgeva biosimilars (SB16) were approved as two separate products for osteoporosis treatment and prevention of skeletal-related events, differing in dosage and administration frequency.
The industry anticipates that the regulatory changes will significantly alleviate the development burden for biosimilars. In particular, the reduction of clinical trial burdens, which account for about half of development costs, is expected to enhance development efficiency.
With the easing of regulations, the entry of latecomer companies into the market is expected to increase. However, analysts note that the existing leading companies' advantages are unlikely to be easily shaken, as large-scale production infrastructure, data, and global regulatory experience remain key competitive factors.
Lee Seung-kyu, vice president of the Korea Bio Association, stated, "Biosimilar development companies are likely proceeding with their development plans while considering the possibility of regulatory easing. While competition will intensify with the entry of latecomer companies, the accumulated development and regulatory experience and know-how will continue to serve as a competitive advantage for existing firms."
* This article has been translated by AI.
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