As the U.S. Congress moves to overhaul the system to lower barriers to entry for the biosimilar market and limit abuse of patents for original drugs, Korean biosimilar corporations are expected to benefit.
In particular, Celltrion and Samsung Epis Holdings' subsidiary Samsung Bioepis, which are already expanding their market share in the United States, are expected to gain momentum in their growth.
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) a biosimilar deregulation bill to expedite market entry of biosimilars. Only votes by the full House and Senate and the president's signature remain.
In addition, the committee plans to deliberate bills such as the Fair Pricing and Patent Integrity for Medicines Act and the Ensuring Timely Access to Generic Medicines Act.
◇ "Block monopolies by original drugs"… U.S. cuts biosimilar development expense and time ↓
These bills commonly aim to ease market monopolies by original drugs and promote market entry for biosimilars and generic drugs. The industry says that if the deregulation bills are finally passed, the growth of the U.S. biosimilar market will accelerate further.
The most notable change is the abolition of the "interchangeable" designation. The United States currently operates an interchangeable biosimilar system separate from biosimilars. Products that obtain interchangeable status can be substituted for the original at pharmacies without a change in the physician's prescription, but they must undergo additional clinical trials and a separate review to do so.
When the bill takes effect, FDA-approved biosimilars will automatically receive interchangeable status without additional review. In effect, the distinction between biosimilars and interchangeables will disappear. As a result, development expense and authorization burdens will fall, market entry will speed up, and pharmacy-level substitution is also expected to expand.
The Bioeconomy Research Center said, "Abolishing the interchangeable system is a symbolic change that lowers entry barriers in the U.S. biosimilar market," noting, "Along with this, deregulation for biosimilars such as waiving phase 3 trials is getting underway, and with many blockbuster biologics facing patent expirations over the next 10 years, biosimilar developers' additional clinical and approval burdens are expected to ease and market entry to quicken."
The U.S. government's push to foster biosimilars is already becoming visible. In March, the FDA said it would allow skipping or simplifying pharmacokinetic (PK) evaluations when scientifically justified. It also allowed skipping "three-way PK studies" comparing a biosimilar under development with the U.S. reference product and an overseas comparator when certain conditions are met, and created a rapid investigational new drug (IND) pathway to reduce IND burdens.
◇ Celltrion and Samsung Bioepis seen benefiting; competition 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 securing interchangeable status has affected market competitiveness, abolishing the system will significantly reduce the burden on biosimilar corporations."
Celltrion has received FDA approvals for 10 biosimilars in the United States. It is preparing to launch the subcutaneous (SC) formulation of the autoimmune disease treatment "Abtozma" and the chronic urticaria treatment "OMLYCLO" in the U.S., and plans to launch by year-end the ophthalmology treatment Eylea biosimilar "Eydenzelt (Aflibercept)."
Follow-on pipeline development is also underway. Last month, Celltrion received FDA approval for a global phase 3 trial plan for the autoimmune disease treatment "Cosentyx" biosimilar (CT-P55), and the "Keytruda" biosimilar (CT-P51) received Ministery of Food and Drug Safety approval in April and is in phase 3.
Samsung Bioepis currently sells five biosimilars in the United States. The Eylea biosimilar "Opuviz" won FDA approval in 2024 and is slated for launch in January 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 Johnson & Johnson's (J&J) autoimmune disease treatment "Remicade (infliximab)," Celltrion's "Remsima" ranked first among biosimilars with a 30.4% share. Samsung Bioepis' "Renflexis" had 10.5%.
In the market for Swiss Roche's hematologic cancer treatment "Rituxan (rituximab)," Celltrion's "Truxima" posted 38.6%, surpassing the original drug (23.0%). Pfizer's biosimilar followed at 33.1%.
In the market for AbbVie's autoimmune disease treatment "Humira (adalimumab)," Samsung Bioepis' Hadlima had 17.3%, ranking as the highest among biosimilars after the original Humira (40.2%), while Celltrion's "Yuflyma" posted 8.1%.
In the market for J&J's autoimmune disease treatment "Stelara (ustekinumab)," the original Stelara (36.8%) held first place. Among biosimilars, Biocon showed 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, followed.
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 products, it is catching up with or surpassing original drugs, strengthening its market dominance.
Samsung Bioepis, on the other hand, is maintaining a sales strategy through local partners. However, as Hadlima has recorded the highest share among Humira biosimilars and is raising its profile, the pace of share expansion in the U.S. market is expected to determine its growth trajectory.