The Poland-based generic drugmaker announced that Joerg Windisch will join as head of Polpharma on November 1. The firm said Windisch will lead its efforts to expand in the global biosimilars market, citing clinical development as a key focus.
The appointment is part of an ongoing Polpharma effort to move into biosimilars that began in June when the firm secured a €45m ($m) loan from the European Investment Bank to pay for clinical development and production of drug candidates.
A month later Polpharma signed a biosimilar-focused clinical development and commercialization deal with Boston, Massachusetts-based manufacturer Epirus Biopharmaceuticals.
Windisch’s departure follows just a week after Sandoz – a unit of Swiss drugmaker Novartis – became the first firm to sell a biosimilar in the US with the launch of Zarxio (filgrastim-sndz), its copycat version of Amgen’s neutropenia drug Neupogen.
At Sandoz, Windisch was chief scientific officer with responsibility for global scientific and regulatory policy work and – according to Polpharma – had a leading role in the firm’s biolsimilars programme.
A Polpharma spokeswoman told us: "Mr Windisch was a key contributor to obtaining Sandoz' approval of all biosimilars in Europe, US as well as other important global markets."
"Not only does he have regulatory experience but his co-operation with regulators helped shape the guidelines and pathways globally."
"He was also a key figure in obtaining US FDA approval for Zarxio" she added.
A Sandoz spokesman told us “We thank Joerg for his invaluable contributions during the past 20 years and wish him the very best in his new endeavor.
“We look forward to continued collaboration with Joerg as part of the European Generics Association and European Biosimilars Group” he added.
Windisch is chairman of the European Biopharmaceuticals Group (EBG), which is an industry organization that interacts with the European Commission (EC) and the European Medicines Agency (EMA).