A prequalification pilot designed to assess biosimilar versions of Roche’s Rituxan and Herceptin has attracted global interest from manufacturers, says WHO executive.
Pfizer has launched the first biosimilar to J&J’s Procrit and Amgen’s Epogen in the US at a ‘significant discount’ to competitors’ wholesale acquisition costs.
Unlike the European system, manufacturing authorisation holders in Jordan must own or operate from a manufacturing facility to apply for biosimilar approval, says JFDA executive.
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.
