PTAB Clears Path For Earlier Generic Zytiga Launch
Patent Trial and Appeal Board finds that the patent covering the blockbuster prostate cancer drug is unpatentable, which could allow generics to launch at-risk in October once they obtain FDA approval; at least 12 firms have pending ANDAs.
You may also be interested in...
The pharmaceutical business continues to withstand the arrival of more Remicade biosimilars and the firm maintains it will have solid growth even with generic competition to its Zytiga.
Investors are keen to see how J&J's Remicade is holding up to biosimilar competition, especially now that Zytiga generics are on the way. Novartis is likely to play up the potential for new launches like siponimod in multiple sclerosis and Aimovig in migraine, while Roche is expected to continue delivering strong performance for core brands and expansion plans for Tecentriq.
Protocol changes for the Phase III ARCHES and EMBARK trials will deliver results in hormone-sensitive prostate cancer a year and a half earlier than expected. Xtandi may then gain a valuable new indication sooner than anticipated, but generics for competitor Zytiga could launch before then.