Biotech

A summary of biopharmaceutical approvals in the US and UK from January 2010 to July 2014 showed that 54 products were approved. Drugs new to the market accounted for 59% of the therapies (32), with the remaining biologics being biosimilars, reformulated and me-too drugs, and products that previously had been approved elsewhere. Of the 32 new therapies, 30 had novel active biopharmaceutical ingredients, while the remaining two shared their new active ingredient. The most common product types approved were monoclonal antibodies (17), hormones (9) and blood-related proteins (8). The approved biopharmaceuticals were most commonly used for treating cancer (9), inflammation-related conditions (6) and hemophilia (6). Nine biosimilar monoclonal antibodies have reached phase 3 trials, as have at least six stem-cell and related products. The total number of biopharmaceuticals in the two countries that have received approval is now 246, although 34 of them have since been withdrawn from both markets.

Source: Nature Biotechnology

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