Daewoong Pharmaceutical said on the 2nd it will develop a Dupixent biosimilar (biosimilar). Dupixent, co-developed by French drugmaker Sanofi and U.S. company Regeneron, is a blockbuster medicine that posted 27 trillion won in sales last year.
Daewoong Pharmaceutical recently signed a contract with global contract development and manufacturing organization (CDMO) Chime Biologics to develop a Dupixent biosimilar. It said the two sides will cooperate from biosimilar development to manufacturing and commercialization.
The U.S. Food and Drug Administration (FDA) approved Dupixent as an atopic dermatitis treatment in 2017, and it entered Korea the following year. The Dupixent patent is set to expire in 2029. In addition to Daewoong Pharmaceutical, domestic corporations including Chong Kun Dang pharmaceutical, Kyungdong Pharm, and Samsung Bioepis are jumping into the competition to capture the biosimilar market. There is no Dupixent biosimilar approved by the U.S. Food and Drug Administration yet. If a domestic company succeeds in developing a biosimilar and secures just 5% of Dupixent's sales, it could generate sales in the 1 trillion won range.
Dupixent is expanding its indications to asthma and chronic obstructive pulmonary disease as a sales decline becomes inevitable. 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 and can defend the market.
Daewoong Pharmaceutical plans to grow the Dupixent biosimilar as a next-generation product following Nabota (botulinum toxin). Chief Executive Park Sung-su of Daewoong Pharmaceutical said, "It will serve as a springboard to fully launch the biosimilar business."