‘Stabilize’ Is The Message For Teva In North America As It Plots Return To Growth
Israeli Firm Posted Weaker Q4 Numbers Amid Lower Lenalidomide, Truxima Revenues
“The value that generics bring to the healthcare industry, to the hospitals, to society is not reflected in the price that we can sell them at,” Teva told investors, as it outlined plans to mitigate erosion with a slate of big-ticket launches in the US.
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Alvotech has ensured there won’t be any legal hurdles to overcome as it plots launches via commercialization partners for its AVT04 proposed biosimilar to Stelara in major global markets.
Alvotech has revealed details of exactly when it expects to win US FDA approvals for its Teva-partnered Humira and Stelara biosimilars, after an agency reinspection of its manufacturing plant in Reykjavik, Iceland resulted in just a single “readily addressable” Form 483 observation.
Teva has gone one better than earlier ANDA settlers Hikma and Sun after winning its long-running legal battle against Corcept Therapeutics over Korlym IP. However, the Israeli firm appears unlikely to launch at risk following an immediate appeal.