As an increasing number of biosimilar developers target the European market, lesser-known firms may explore alternative commercialisation strategies, says Iqvia executive.
After the business was asked by the US FDA to provide more data to secure an approval for its biosimilar, Sandoz decided not to pursue its regulatory filing any further.
Within days of Samsung Bioepis sending its Soliris candidate to the clinic, the firm details its development process, novel biologics ambitions, and plans to become ‘the single dominant player in biosimilars’.
The first MabThera biosimilar is expected to enter the US market in the first half of 2019, followed by Herceptin and Avastin versions in the second half of the year, says CEO.
Leaf Expression Systems’ technology enables the manufacture of proteins, vaccines and complex biomolecules without using animal-based products, says recently appointed chief executive.
