Latest from Dave Wallace
With European biosimilars developers buoyed by recent regulatory moves, Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil discuss the next steps forward for the industry.
With European biosimilars developers buoyed by recent regulatory moves, Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil discuss the next steps forward for the industry.
At a busy meeting of the CHMP, the EMA issued positive opinions for Fresenius Kabi’s denosumab rivals to Prolia and Xgeva, another denosumab biosimilar from Sandoz, a Tecfidera hybrid from Neuraxpharm and a Descovy generic from Viatris. Meanwhile, Ascend has withdrawn a teriparatide filing.
Spanish biosimilars developer mAbxience has struck a deal with Italy’s Abiogen covering an undisclosed biosimilar for the Italian market.
Lupin is planning to make inroads into the Latin American biosimilars market through a deal with local player SteinCares for a ranibizumab rival to Lucentis.
Hikma is set to make its first launch into the competitive US biosimilars market after its Bio-Thera-partnered Stelara rival, Starjemza, was approved by the FDA.