Company's application development seems to be outpacing FDA's policy development in next step along the 351(k) pathway.
Sandoz Inc.'s application package for its biosimilar to Amgen Inc.'s Enbrel continues to signal to FDA that the company is ready to move forward on interchangeability even if the agency is not.
A clinical study with multiple switches between GP2015 and its reference product was part of Sandoz's application to determine it...
Generics Bulletin reviews global regulatory developments across the world.
The group had been laid off as part of the 1 April reduction-in-force, which lead to missed guidance publication deadlines.
After multiple past attempts, US legislators have once again proposed a bill that would make all biosimilars immediately interchangeable upon approval. Could a fresh political context help it to succeed this time?
Doubling down on the launch of its Stelara biosimilar Pyzchiva in Europe last year, Sandoz has just released an autoinjectable version of the drug, with the aim to offer a more convenient option for ustekinumab patients.
