Immediate EU-wide measures are needed to ensure the supply of medicines, according to off-patent industry association Medicines for Europe, which has also called for clear regulatory guidance and scenario planning to address the challenges posed by the coronavirus outbreak.
Three key actions are needed to ensure the supply of medicines in Europe as the region grapples with the effects of the coronavirus outbreak, according to Medicines for Europe.
The off-patent industry association has made “three key requests” – for immediate and urgent actions to ensure supply; regulatory guidance;...
Denosumab, aflibercept and ustekinumab biosimilars received positive opinions from the EMA’s CHMP at its meeting in July, along with an Opsumit generic from Accord.
Generics Bulletin reviews global regulatory developments across the world.
Bio-Thera is one step closer to launching a biosimilar to Johnson & Johnson’s Simponi in the US, following FDA acceptance of its BAT2506 proposed golimumab candidate.
As a standalone generics and biosimilars company, Sandoz now feels freer to speak out against originator abuses of intellectual property, the firm’s global IP head Julia Pike tells Generics Bulletin, including challenges to Bayer on rivaroxaban and Amgen on etanercept.
