According to Celltrion, the executive order is designed to reduce the amount Americans pay for prescription drugs by aligning U.S. prices with the lowest available in other nations. Key elements include:
The U.S. Secretary of Health and Human Services (HHS) is instructed to develop a program allowing patients to purchase prescription drugs at the “most-favored-nation” (MFN) price. HHS must inform pharmaceutical companies of the MFN pricing goals within 30 days.
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Opportunities from Streamlined Distribution
One of the most significant aspects of the order is the overhaul of the U.S. drug distribution network, particularly the role of PBMs. Celltrion sees this as a positive development for its U.S. operations.
In particular, direct pricing negotiations between biosimilar companies and the government by passing PBMs could create mutually beneficial outcomes for both parties.
Price Reductions Could Accelerate Biosimilar Adoption
Another core aspect of the executive order is its focus on lowering prices for expensive drugs.
Currently, U.S. insurance and PBM systems prioritize high-priced original biologics, with only limited competition allowed from biosimilars. Due to PBM rebates and other intermediary incentives, biosimilars are often priced close to the original products, limiting actual savings for patients and stalling market growth compared to Europe.
The company also pointed to opportunities from the potential expansion of parallel imports if the MFN pricing strategy leads to increased cross-border drug supply.
Such a change could allow Celltrion to launch additional products in the U.S. market. With an established direct sales network in the U.S. and experience in Europe, the company believes it can use its broader product portfolio and marketing know-how to drive sales growth.
“This executive order, upon thorough review, appears favorable to biosimilar manufacturers,” said a Celltrion spokesperson. “It could present a significant opportunity, especially for companies like Celltrion that already conduct direct sales of biosimilars in the U.S.”
The spokesperson added that Celltrion will continue to monitor the U.S. government’s implementation of the policy and respond with flexible, adaptive strategies as the situation evolves.