Expanding US Biosimilar Market... Emerging 'Interchangeability'

Domestic Companies Also Strive to Secure Competitiveness Through Related Clinical Trials

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In the United States, the world's largest pharmaceutical market, securing interchangeable biosimilars is becoming increasingly important to gain a competitive edge in the biosimilar (biopharmaceutical generic) sector.

According to industry sources on the 26th, Samsung Bioepis's ophthalmic biosimilar 'Byooviz' has been designated as an interchangeable biosimilar by the U.S. Food and Drug Administration (FDA). This is the first time a Korean company has obtained interchangeable biosimilar status from the FDA.

Byooviz is a biosimilar of 'Lucentis,' an ophthalmic treatment for diseases such as macular degeneration and diabetic macular edema developed by Genentech (a Roche subsidiary). The drug is administered by directly injecting the antibody medicine into the patient's eye. A Samsung Bioepis representative stated, "By emphasizing to local doctors that Byooviz is an interchangeable biosimilar, we expect to expand our market reach."

Due to the nature of biopharmaceuticals, which are difficult to produce identically, biosimilars must prove 'similarity' rather than equivalence. This is why cross-prescription and substitution are more challenging for biosimilars compared to generics (synthetic drug generics). However, if interchangeability is secured and the biosimilar becomes interchangeable, pharmacists can dispense the biosimilar even if the doctor prescribes the original drug.

While there is a movement in Europe to eliminate distinctions between original drugs and biosimilars, securing interchangeable biosimilars is becoming crucial in the U.S. Interchangeable biosimilars must additionally prove that there are no risk factors when substituting the original drug compared to regular biosimilars. This reduces the burden on medical professionals regarding substitution prescriptions, and patients can receive highly safe drugs at 20-30% lower costs than the original, making it an attractive option.

The most intense competition for interchangeable biosimilars is in the autoimmune disease treatment market for 'Humira.' This blockbuster drug recorded global sales of $21.237 billion (approximately 29 trillion KRW) last year, with $18.619 billion (approximately 25 trillion KRW) in sales in the U.S. alone. Boehringer Ingelheim's 'Cyltezo' and Pfizer's 'Avsola' have already received interchangeable biosimilar certification and are attempting to increase market share. Unlike Lucentis, which requires direct injection by a doctor, Humira is a subcutaneous (SC) formulation that patients can self-inject at home, allowing substitution at pharmacies and making the securing of interchangeability highly significant. Samsung Bioepis has completed interchangeability confirmation clinical trials and is in the process of applying for product approval, while Celltrion is conducting global clinical trials.

An industry insider explained, "Humira can be prescribed by pharmacists through pharmacy distribution rather than hospital distribution, so the sales landscape will clearly change depending on whether interchangeable biosimilars are available," adding, "Domestic companies are not hesitating to invest hundreds of millions of won in related clinical trials to secure even a 1% additional market share."

This content was produced with the assistance of AI translation services.