Latest from Urtė Fultinavičiūtė
Respondents to the FDA’s questions over biosimilar development did not hold back. So, what is it: product-specific or product class-specific guidance? Or nothing?
After a “remarkable performance” in Q2, Samsung Bioepis enjoyed a calm, but still profitable, third quarter.
Celltrion gave updates on several business aspects and reassured its shareholders that the delayed insurance listing for Zymfentra will not affect its set annual sales goal.
With marketed European biosimilar rivals already making a dent in Stelara’s sales performance, Johnson & Johnson mourns its blockbuster’s upcoming loss of exclusivity across the Atlantic Ocean.
Backed by AI and former FDA official Janet Woodcock, Every Cure is set to identify approved drugs for patients who don’t have treatment options around the world.
Along with other approaches, early market entry of generics and biosimilars would barely make a dent in reducing the net prices of retail prescription drugs in the US – but even then, small reductions would add up to billions, reveals the latest CBO calculation.