Amgen’s Prolia Sees Price Cut with Biologics Premium Applied
Biosimilar Entry Triggers Price Adjustment Amgen Benefits from “Innovative Pharmaceutical” Designation
As of April 1, the price ceiling for Amgen’s osteoporosis treatment Prolia (denosumab) has been lowered. The adjustment includes a biologics premium, granted due to Amgen’s recognition as an “Innovative Pharmaceutical Company.”
According to the Ministry of Health and Welfare (MOHW), the maximum reimbursement price for Prolia Prefilled Syringe has been reduced from $109.31 to $87.45. This change follows the reimbursement listing of Celltrion’s biosimilars Stoboclo and Osenvelt, priced at $78.70 and $124.34, respectively.
Under Korea’s pricing system, when a drug with the same formulation is newly listed, the original product’s price is typically reduced to 53.55% of the initial price (or 70% for biologics). To moderate these reductions and support market competition, temporary premiums are applied: 70% for original drugs, 59.5% for generics (68% for those by innovative firms), and 80% for biologics.
These premiums are valid for one year but may be extended. If only three or fewer equivalent products remain on the market after the initial year, the premium may be extended by up to three years, with a possible two-year extension upon recommendation by the Drug Reimbursement Evaluation Committee (DREC).
Prolia’s latest price reflects 80% of the original rate, consistent with the biologics premium framework following biosimilar entry.
To qualify for the biologics premium, a product must undergo South Korean clinical testing and meet at least one of the following DREC-approved conditions:
① Developed by an innovative pharmaceutical company or an equivalent
② Co-developed under a recognized Korean-foreign R&D agreement
③ First approved in Korea
④ Fully manufactured in Korea
Stelara (ustekinumab) previously received a similar pricing adjustment due to Janssen Korea’s innovative status and South Korean clinical trials.
Prolia met the criteria through local clinical trials and Amgen’s designation as an innovative pharmaceutical company, granted on December 28 of last year.