Abstract
Several companies are trying to overcome manufacturing roadblocks that stopped their new drugs from being approved by FDA in 2016. In responses to their applications, FDA cited problems found during preapproval plant inspections. Most problems were in Western facilities and centered on formulation, rather than active ingredient production. Only two companies—AstraZeneca and Opko Health—responded to the problems in time to refile in 2016. And Opko got an approval after its manufacturing partner, Catalent, fixed problems at its St. Petersburg, Fla., extended-release capsule plant. Ocular Therapeutix expects to refile this quarter, while Roche’s review is delayed until late March. Meanwhile, Sanofi and Regeneron Pharmaceuticals face a major setback for the potential blockbuster drug sarilumab, a monoclonal antibody targeting the interleukin-6 receptor. If approved, it will compete in the rheumatoid arthritis field against Abbvie’s Humira, the industry’s top-selling drug. During an October earnings call, Sanofi CEO Olivier Brandicourt said the company was
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