The patent for Dupixent, called the "miracle atopic dermatitis treatment," will expire around 2031.
Dupixent was co-developed by French drugmaker Sanofi and U.S. biotech Regeneron and posted $14.1 billion (about 20.8 trillion won) in sales in 2024. Korean pharmaceutical and biotech corporations have jumped into the race to capture the market by developing a Dupixent biosimilar (biosimilar).
According to the pharmaceutical-bio industry on the 14th, KyungDong Pharm is currently developing a Dupixent biosimilar. It is in the pre-development stage to initiate a phase 1 clinical trial. Founded in 1976, KyungDong Pharm focused on synthetic drugs but plans to expand into biosimilars starting with Dupixent. Because biosimilars are biopharmaceuticals, they tend to have fewer side effects than synthetic drugs and carry higher unit prices.
KyungDong Pharm signed a collaboration agreement with Protium Science, a biopharmaceutical contract development corporations, to develop a Dupixent biosimilar. They will work together on cell line and culture/purification process development, analysis of biologic drug substances, and formulation development. The company's position is that this will spread development risk and reduce expense and time.
KyungDong Pharm plans to expand biopharmaceutical development to include antibody therapies and treatments for immune diseases. A KyungDong Pharm official said, "Based on our experience in developing, approving, manufacturing, and distributing synthetic drugs, we will expand into the biosimilar business," adding, "Our goal is to launch a biosimilar after the Dupixent patent expires."
Samsung Bioepis is also in the early stages of developing Dupixent. It has not yet begun a phase 1 clinical trial. A Samsung Bioepis official said, "We judged that the commercial viability of the original drug is assured."
Daewoong Pharmaceutical is also reviewing development of a Dupixent biosimilar. To develop biosimilars, the company hired Hong Seung-seo, who served as head of research at Celltrion, as head of the biosimilar (BS) business headquarters.
Daewoong Pharmaceutical judges that the biosimilar industry has high growth potential. According to market research firm Insight Market Research Consulting Group, the global biosimilar market is projected to grow from $26.5 billion (40 trillion won) in 2024 to $185.1 billion (273 trillion won) in 2033. Overseas markets such as Europe are pursuing measures to waive phase 3 trials when developing biosimilars. The company said, "The analysis is that it has become possible to reduce development risk while boosting cost competitiveness."
The U.S. Food and Drug Administration (FDA) approved Dupixent as an atopic dermatitis treatment in 2017. It entered the Korean market in 2018, the following year, and was covered by health insurance in 2020. Dupixent inhibits the signaling of the cytokines "interleukin-4 (IL-4)" and "interleukin-13 (IL-13)," which affect the pathogenesis of atopic dermatitis.
Once Dupixent's patent exclusivity ends, biosimilars can enter the market. There is currently no Dupixent biosimilar approved by the U.S. Food and Drug Administration. If a domestic corporations succeeds in developing a biosimilar and captures just 5% of Dupixent's sales, it could post 1 trillion won in revenue. Dupixent, on the other hand, is bound to see a drop in sales.
Dupixent is expanding its indications to asthma, sinusitis, and chronic obstructive pulmonary disease. Indications refer to diseases or symptoms for which a drug's therapeutic effect is expected. Expanding indications increases the number of patients who can be prescribed the drug.
An industry official said, "When a patent on an original drug ends, biosimilars flood in and profitability can worsen," adding, "Expanding indications has the effect of expanding the market to that extent, making a kind of defense possible."