As the U.S. Congress moves to overhaul the system to lower entry barriers to the biosimilar (biosimilar) market and to limit the abuse of patents for original drugs, Korean biosimilar corporations are expected to benefit.
In particular, the growth momentum of Celltrion and Samsung Epis Holdings' subsidiary Samsung Bioepis, which are already expanding market share in the United States, is expected to gain strength.
According to the Korea Biotechnology Industry Organization's Bioeconomy Research Center on the 19th, the U.S. Senate Committee on Health, Education, Labor and Pensions (HELP) unanimously passed on the 17th (local time) the Biosimilar Red Tape Reduction Act to expedite biosimilar market entry. Only floor votes in both chambers and the president's signature remain.
In addition, the committee plans to deliberate on the Fairness in Drug Prices and Patent Integrity Act and the Ensuring Timely Access to Generic Drugs Act.
◇ "Stop original drug monopolies"… U.S. lowers biosimilar development cost and time ↓
These bills commonly aim to ease market monopolies by original drugs and to promote the market entry of biosimilars and generic drugs. The industry says that if the deregulatory bill is finally passed, growth in the U.S. biosimilar market will accelerate further.
The most notable change is the repeal of the "interchangeable" designation. The United States currently operates an interchangeable biosimilar system separate from biosimilars. Products that obtain interchangeable status can replace the original drug at pharmacies without a change in the physician's prescription, but they must undergo additional clinical trials and separate reviews to do so.
If the bill is finally passed, biosimilars approved by the FDA will automatically receive interchangeable status without additional separate review. In effect, the distinction between biosimilars and interchangeables will disappear. As a result, development expense and approval burdens will decrease, market entry will speed up, and pharmacy-level substitution is also expected to expand.
The Bioeconomy Research Center said, "Repealing the interchangeable system is a symbolic change that lowers entry barriers in the U.S. biosimilar market," and added, "Along with this, deregulation for biosimilars, such as waiving phase 3 trials, is gaining momentum, and as many blockbuster biologics are set to lose patent protection over the next 10 years, biosimilar developers' additional clinical and approval burdens will ease and market entry will likely accelerate."
The U.S. government's stance to foster biosimilars is already becoming visible. In Mar., the FDA issued guidance that, where scientifically justified, pharmacokinetic (PK) evaluations can be omitted or simplified. If certain conditions are met, the "three-way PK study" comparing a biosimilar under development with the U.S. reference product and an ex-U.S. comparator can also be omitted, and a rapid IND pathway was newly established to reduce Investigational New Drug (IND) burdens.
◇ Celltrion and Samsung Bioepis seen benefiting… race to expand U.S. share
These regulatory changes are expected to work favorably for Celltrion and Samsung Bioepis, which sell multiple biosimilars in the U.S. market. An industry official said, "Because obtaining interchangeable status has affected competitiveness, repealing the system will significantly reduce the burden on biosimilar corporations."
Celltrion currently has FDA approvals for 10 biosimilars in the U.S. market. It is set to launch the subcutaneous (SC) formulation of the autoimmune disease treatment "Abtozma" and the urticaria treatment "OMLYCLO" in the United States, and plans to launch by year-end the Eylea biosimilar "Eydenzelt (Aflibercept)" for ophthalmic diseases.
Follow-on pipeline development is also underway. Last month, Celltrion received FDA approval for a global phase 3 trial plan for the "Cosentyx" biosimilar (CT-P55) for autoimmune diseases, and the "Keytruda" biosimilar (CT-P51) received Ministery of Food and Drug Safety approval in Apr. and is in a phase 3 trial.
Samsung Bioepis currently sells five biosimilars in the United States. The Eylea biosimilar "Opuviz" received FDA approval in 2024 and is slated for launch in Jan. next year. The Keytruda biosimilar is in a phase 3 trial for Non-small cell lung cancer (NSCLC) patients and is expected to be completed within the year.
Both companies' U.S. market shares are steadily rising. According to May U.S. biosimilar prescription data compiled by Daol Investment & Securities, in the market for "Remicade (infliximab)," an autoimmune disease treatment from Johnson & Johnson (J&J), Celltrion's "Remsima" ranked first among biosimilars with a 30.4% share. Samsung Bioepis' "Renflexis" held 10.5%.
In the market for "Rituxan (rituximab)," a blood cancer treatment from Switzerland's Roche, Celltrion's "Truxima" reached 38.6%, surpassing the original drug (23.0%). Pfizer's biosimilar followed with 33.1%.
In the market for "Humira (adalimumab)," an autoimmune disease treatment from AbbVie, Samsung Bioepis' Hadlima posted 17.3%, the highest share among biosimilars after original Humira (40.2%), while Celltrion's "Yuflyma" recorded 8.1%.
In the market for "Stelara (ustekinumab)," an autoimmune disease treatment from J&J, the original Stelara (36.8%) held first place. Among biosimilars, Biocon had the highest share at 32.3%, followed by Celltrion's "Steqeyma" at 13.3%. Samsung Bioepis' "Pyzchiva" (4.8%) and Dong-A ST's "IMULDOSA" (0.3%), launched in the U.S. in May last year, trailed.
The industry assesses that Celltrion, which has built a direct sales network in the United States, is rapidly expanding share across key product lines. In some categories, it is catching up with or overtaking original drugs, strengthening market dominance.
Meanwhile, Samsung Bioepis is maintaining a sales strategy through local partners. Still, Hadlima is increasing its presence with the highest share among Humira biosimilars, and the pace of share gains in the U.S. market is expected to determine its growth trajectory.