Omnitrope, the pioneering biosimilar of the recombinant human growth hormone somatropin, has received regulatory approval as the first-ever
biosimilar in Japan under the brand name Somatropin BS S.C. This approva
l paves the way for greater access to high-quality biopharmaceuticals in the world’s second-largest pharmaceuticals market and comes
about three months after Japanese authorities published guidelines for a biosimilar regul
...[+++]atory pathway, which is based on similar scientific principles already in place in the European Union.