As we start the new year, a look at the past year helps to shed light on the industry’s future. One indicator is the number of new products that have successfully reached the market. With industry trends towards New Molecular Entities (NMEs) and Biologics, the rising number of new products approved in this sector is promising: In 2012, the US FDA’s Center for Drug Evaluation and Research increased the number of NMEs and Biologics they approved, surpassing the number of approvals in 2011.
FDA Becomes More Lenient
In the month of December alone, the FDA approved seven new drugs, bringing the total up from last year by nine. The number of NMEs approved is still disproportionately greater than Biologics approvals, but the overall rate of approval is higher (39 vs 30) and the median time for approval is shorter (9 months vs 10 months) compared to the previous year.
Of course this is not the only determining factor, and some companies are doing better than others. Among large pharmaceutical companies, Pfizer appears to be the company that has the most approvals, although there are several others. Astellas, Eisai, Forest Laboratories, Roche/Genentech, Sanofi, and Teva each had more than one approval last year.
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