The price ceiling for Janssen Korea's autoimmune treatment 'Stelara' will be reduced following the inclusion of Samsung Bioepis's biosimilar 'Epyztek' in the reimbursement list as of July 1st. This inclusion has prompted a mandatory price revision for Stelara, which will also benefit from an added value.

According to the Ministry of Health and Welfare's announcement, the price ceiling for four Stelara products will be adjusted starting August 1st. Stelara Prefilled Syringe and Stelara Subcutaneous Injection 45mg/0.5mL will be reduced from the current $1575.76 to $1260.61. Stelara Prefilled Syringe 90mg/1mL will drop from $1629.20 to $1303.36, and Stelara Intravenous Infusion will decrease from $1633.17 to $1306.54.

Under the current drug pricing system, when a biosimilar of an initially listed product is registered, the original's price is adjusted to 53.55% (70% for biologics) of its previous value. However, to prevent a sharp price drop and encourage the market entry of generics, a higher price addition is applied for a certain period. This addition is set at 70% for originals, 59.5% for generics (68% for innovative drugs), and 80% for biologics.

The added value is maintained for one year. If there are three or fewer companies with the same product after one year, this addition can be extended for up to three years until there are more than four companies. After three years, an additional two-year extension can be granted based on the Drug Reimbursement Evaluation Committee's opinion.

Following the introduction of a biosimilar, the price ceiling for Eylea was reduced to 70% as of July 1st. In contrast, Stelara will receive an 80% added value on its current price ceiling.

To qualify for the added value on biologics, a product must have conducted clinical trials in South Korea and meet at least one of four specific criteria:

① The product is developed by an innovative pharmaceutical company or a company recognized as equivalent by the Drug Reimbursement Evaluation Committee.

② The product is recognized by the committee as being developed through a joint R&D contract between a domestic company and a foreign pharmaceutical company.

③  The product was first approved in South Korea.

④  The product is recognized by the committee as being entirely produced in South Korea.

In the case of Stelara, clinical trials were conducted in South Korea, and Janssen holds the status of an innovative pharmaceutical company, thus qualifying for the added value instead of the 70% price ceiling.

A company representative stated, "It is challenging to meet the requirements for the added value of initially registered biologics. We received the added value by submitting and proving the data from the clinical trials conducted domestically, as an innovative pharmaceutical company."