Genentech's Ocrevus Manufacturing Process Still A Work In Progress
Genentech overcame objections from US FDA quality reviewers to win approval of Ocrevus for multiple sclerosis by adding release and stability testing and committing to resolving process control issues, while suspending plans to accelerate post-approval manufacturing changes.
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No European approval recommendation for Roche multiple sclerosis drug Ocrevus but the Swiss major tells Scrip it is hopeful of getting approval within four months.
The CHMP's assessment of Roche's novel multiple sclerosis therapy Ocrevus continues, making a year-end approval unlikely.
New treatments for plaque psoriasis and ovarian and prostate cancer join the first Herceptin biosimilar and several other products in garnering recommendations for EU marketing approval at September's meeting of EMA's key scientific committee, the CHMP. No decision was taken on Roche’s new MS drug, Ocrevus, and earlier negative opinions of three other products were upheld.