Rising development costs of biosimilars make US market entry difficult proposition

Clearing the U.S. regulatory hurdles is expected to be an arduous exercise for Korean firms, said President Song Byung-doo of Scripps Korea Antibody Institute (SKAI).

In a local SKAI symposium, Song said that Biosimilar development is riddled with complexities, ranging from regulatory, to manufacturing to marketing, and is one of the most expensive propositions in the pharmaceutical industry...