As patents for global blockbuster medicines expire one after another, competition to develop biosimilars is entering full swing.
With patents for medicines worth hundreds of billions of dollars set to expire over the next 10 years and moves to ease regulations in major markets such as the United States and Europe, corporations with technology and manufacturing capacity are expected to see new growth opportunities.
According to the KoreaBIO on the 13th, patents for medicines worth about $400 billion (592 trillion won) are expected to expire over the next 10 years. However, biosimilars currently in development account for only about 10% of the total, leading to analysis that market readiness remains in its early stages compared to the scale of expirations.
In fact, patent expirations for major biologics are approaching in the global market as well. Merck's (MSD) immuno-oncology drug "Keytruda" (pembrolizumab) will see key patents expire in the United States and Europe between 2028 and 2029.
The atopic dermatitis and asthma treatment "Dupixent" (dupilumab), co-developed by France's Sanofi and U.S.-based Regeneron, is expected to lose patent protection around 2031, while the multiple myeloma treatment "Darzalex" (daratumumab), with $14.3 billion (about 21 trillion won) in sales, is projected to see its patents end in 2029 in the United States and in 2031 in Europe.
The regulatory environment is also shifting in favor of biosimilar development. The U.S. Food and Drug Administration (FDA) on the 10th (local time) released a draft industry guidance streamlining biosimilar development procedures.
The core of the guidance is to reduce the burden of clinical pharmacokinetic (PK) studies. When scientific validity is demonstrated, unnecessary PK studies can be streamlined to cut research expense by up to 50%.
The scope for using comparator products and clinical data has also expanded. Under certain conditions, overseas clinical data outside the United States may be used to demonstrate similarity, and the rules were relaxed to recognize cases where a "three-way PK study" comparing a biosimilar, the U.S. reference product, and an overseas comparator product simultaneously is not required.
The U.S. government's drug price reduction policy supports this trend. The aim is to expand biosimilars to lower medical costs. In the United States, biologics account for about 5% of total prescriptions but more than 50% of drug expenditure.
Global drugmakers are also reorganizing their structures and strategies in preparation for the expansion of the biosimilar market. Sandoz of Japan, regarded as the world's largest biosimilar corporations, has formed a dedicated unit, and U.S.-based Amgen and Pfizer are also pursuing both new drug development and biosimilar businesses to respond to the market. Their biosimilar sales account for about 10% of total revenue, but the share is gradually increasing.
Opportunities have opened for Korean corporations as well. Domestic biotech corporations are assessed to possess both antibody drug development technology and large-scale manufacturing capacity.
Celltrion plans to expand its product portfolio from the current 11 to 41 by 2038, and Samsung Epis Holdings subsidiary Samsung Bioepis has commercialized 11 biosimilars and aims to increase the number to more than 20 by 2030.
In addition, Alteogen, Sam Chun Dang Pharm, LG Chem, Chong Kun Dang pharmaceutical, and Dong-A ST are also expanding biosimilar development.
An industry official developing biosimilars said, "With global blockbuster patent expirations dovetailing with regulatory easing, growth opportunities have increased for corporations with technology and manufacturing bases," adding, "The next 10 years will be a period when biosimilar competition and market expansion enter full swing."