Samsung Bioepis, First in Korea to Obtain US FDA Interchangeable Biosimilar Approval

Novartis' Lucentis Biosimilar Byooviz

Samsung Bioepis's biosimilar for macular degeneration treatment, Byooviz, has been designated as an interchangeable biosimilar by the U.S. Food and Drug Administration (FDA). An interchangeable biosimilar refers to a biosimilar that pharmacists can substitute for the original medicine prescribed by doctors in the U.S., Europe, and other countries without the doctor's consent. This is the first time a Korean company's product has been designated as an interchangeable biosimilar by the FDA.

According to the Korea Bio Association on the 25th, Samsung Bioepis's Byooviz was officially designated as interchangeable through an FDA approval amendment letter earlier this month. Byooviz was previously approved as a biosimilar by the FDA in September 2021.

The original drug for Byooviz is Lucentis, developed by Swiss company Novartis. It is an ophthalmic treatment mainly used for macular degeneration and other eye diseases. Macular degeneration is a condition where waste accumulates in the macula, the central part of the retina, eventually causing excessive blood vessel growth that can lead to blindness. Lucentis, which is injected directly into the eye, works by binding to vascular endothelial growth factor (VEGF)-A, inhibiting the formation of new blood vessels and slowing disease progression.

The bio industry expects that Samsung Bioepis's Byooviz being designated as an interchangeable biosimilar will make it easier to target the related market in the U.S. This is because interchangeable biosimilars have the advantage of being substitutable for the original drug.

A representative from the Korea Bio Association explained, "Interchangeable biosimilars are not necessarily superior to biosimilars in terms of safety and efficacy, but local doctors and pharmacists are known to feel less burden when it comes to substitution."

Samsung Bioepis is the first Korean company to obtain FDA certification as an interchangeable biosimilar. As of last month, the FDA has designated a total of 43 biosimilars, of which 6 are interchangeable biosimilars. Besides Samsung Bioepis's Byooviz, other interchangeable biosimilars include Biocon (India) Semglee, Boehringer Ingelheim (Germany) Cyltezo, Eli Lilly (U.S.) Rezvoglar, Coherus Biosciences (U.S.) Simliki, and Pfizer (U.S.) Abrilada.

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