As an innovative new drug that transformed the treatment paradigm for osteoporosis, Prolia reached its peak last year with record-high sales. However, with its patent expiration in March this year and the looming entry of biosimilars, the market landscape is expected to undergo significant changes.

Amgen Korea plans to solidify Prolia's position by responding to these challenges with a strategy that emphasizes “originality” and its accumulated evidence and brand value as the original drug.

Hansam Jung, Bone Marketing Manager of General Medicine at Amgen Korea, who oversees the marketing of Prolia and Evenity, expressed confidence that Prolia would remain a leading example of how original brands can maintain their market position even after patent expiry by reinforcing their brand originality.

‘First-in-Class’ Prolia…targets the market equipped with its long-term data

Prolia (denosumab), which was approved in Korea in 2014 and officially launched at the end of 2016, has been rapidly expanding its influence in the field of osteoporosis treatment.

Initially reimbursed only as a second-line treatment for osteoporosis in 2017, Prolia saw explosive growth after its reimbursement coverage was expanded to include first-line therapy in April 2019.

In fact, Prolia’s domestic sales, which stood at approximately KRW 7.5 billion in 2018 just before the reimbursement expansion, surged to around KRW 44 billion in 2019 and exceeded KRW 80 billion in 2020. Since then, the product has continued to post double-digit growth annually.

A key driver behind this growth has been Prolia’s robust clinical data. As a first-in-class drug that inhibits bone resorption, Prolia significantly improved patient adherence compared to oral therapies, thanks to its convenient dosing schedule of one injection every six months.

It is also the only osteoporosis treatment that has been proven effective and safe for 10 years through a large-scale, long-term clinical trial.

Jung said, “In the 3-year FREEDOM clinical trial and subsequent extension studies in postmenopausal osteoporosis patients, the Prolia group showed a 21.7% increase in vertebral bone density and maintained a non-vertebral fracture incidence rate less than 2%, confirming sustained improvements in bone density and reduced fracture risk through 10 years.”

In particular, the risk of spinal fractures decreased significantly from the first year of Prolia treatment, falling 68% lower than the placebo group, while the risk of hip fractures also decreased by more than 40%.

According to Jung, Prolia has gained trust as a “treatment that maintains its efficacy and safety even with long-term administration,” establishing itself as the standard first-line treatment for osteoporosis based on such data.

“With the addition of real-world prescription experience to the accumulated long-term clinical research data, Prolia is increasingly recognized as a treatment that offers both fracture risk reduction and safety,” said Jung. “We frequently receive positive feedback on its impressive efficacy in improving bone mineral density and its favorable safety profile.”

Prolia biosimilars enter the market... Company seeks a way forward by strengthening its marketing capabilities

Another factor driving Prolia's growth is its meticulous marketing strategy. Amgen Korea joined forces with Chong Kun Dang from the early stages of Prolia's launch to target the Korean market. Through a partnership formed in 2017, Amgen Korea and Chong Kun Dang divided their cooperation according to their respective strengths.

Amgen focused on university hospitals, while Chong Kun Dang targeted smaller hospitals and clinics, ensuring that healthcare professionals across various channels received a consistent message about Prolia's benefits.

Jung explained, “Osteoporosis treatments are prescribed in various departments, so we were able to maximize synergy through collaboration with Chong Kund Dang and leveraging its extensive sales network. As a result, Prolia has expanded its prescription range from university hospitals to local clinics and is now the brand with the highest number of patients and sales in local clinics.”


Amid such strong sales, the market's attention is focused on whether Prolia will be able to keep its lead even after patent expiry.

At the end of March, as soon as Prolia's domestic compound substance patent expired, a cheaper biosimilar was listed for reimbursement. As a result, the price of Prolia was adjusted to KRW 123,760, a 20% reduction, from April 1.

Although such price cuts will directly impact the original drug Prolia’s sales, some observers note that the growing population of osteoporosis patients due to an aging population could offset this decline through market expansion.

Jung said, “As we enter a super-aged society, the number of patients requiring Prolia treatment will continue to increase in the future. While there may be a temporary decline in sales due to the price reduction, we expect to maintain growth by increasing the number of treated patients.”

In fact, Prolia achieved sales of approximately KRW 170 billion in South Korea last year, reaching its growth peak. Amgen Korea plans to continue the steady growth of Prolia based on solid clinical evidence and its power as the original brand.

Jung explained, “In the face of biosimilar launches, we will further highlight Prolia's strong efficacy and 9 years of real-world experience to emphasize its originality. Prolia can be prescribed for osteoporosis treatment across various medical departments, and we believe that our partnership with Chong Kun Dang will maximize synergy.”

Will seek dual brand market penetration with Prolia and Evenity

Meanwhile, Amgen Korea is pursuing a market strategy centered on its ‘Bone Portfolio’ for osteoporosis, leveraging a dual-brand approach with Prolia and Evenity to strengthen its presence in the osteoporosis treatment market.

Evenity (romosozumab) is the world’s first anabolic agent that combines two mechanisms of action—inhibiting bone resorption and promoting bone formation. Introduced in Korea at the end of 2019, it has since established itself as a first-line treatment for patients at very high risk of fracture.

Jung stated, “Prolia and Evenity are key strategic assets unique to Amgen. While their roles differ, we can deliver optimal treatment benefits to a broader range of patients by leveraging their synergy through sequential therapy and other approaches.”

In fact, continuing maintenance therapy with Prolia after 12 months of treatment with Evenity has been shown to provide additional bone density improvement and fracture risk reduction, leading to the active adoption of the “Evenity-Prolia sequential treatment approach” regimen in practice.

Finally, when asked to describe Prolia in one sentence, Jung replied, “The ultimate osteoporosis treatment for a fracture-free future.”

This means that it is a treatment that can help osteoporosis patients achieve a “fracture-free life” through its long-term fracture risk reduction effects.

He added, “Osteoporosis is a chronic disease requiring long-term treatment, and at the core of such sustained therapy is Prolia, which has proven its long-term efficacy through data. We will focus on creating success stories for Prolia to emphasize its originality further and ensure that more osteoporosis patients can benefit from its treatment.”