The Biosimilar drug field is growing fast despite the tight regulatory, business and financial challenges it faces. The industry is forecasted to be worth up to €23Bn by 2020. To explore the market opportunities for biosimilars, it is necessary to be aware of all the latest news and to stand at the forefront of the current landscape of the industry.
BioPharm Insight published a report highlighting some of the major developments occurring in the biosimilar business recently. Some of them were already covered by Labiotech, as the first insulin biosimilar approval in Europe, the first biosimilar approval in the US (here and here) or the world’s first biosimilar monoclonal antibody.
So, first of all, what is it a biosimilar?
Biosimilars are biological drugs that are similar, but not identical to an already-authorized biological treatment (reference product), basically a generic of biological. Because of the difficulty to produce and to characterize these big biomolecules, the security of biosimilars has been questionned.