Up from 2011, but Innovation and Impact Are Limited

摘要

The US Food and Drug Administration (FDA) granted 18 new biopharmaceutical product approvals in 2012, covering a broad range of innovation, novelty, and healthcare and market impact. The total includes 16 full/ original approvals: biologies license applications (BLAs) and new drug applications (NDAs). The other two products received supplemental approvals, both of them influenza vaccines. Among the 18 approvals were eight recombinant proteins, including two monoclonal antibodies (MAbs) and one engineered antibody-like "trap" molecule. Table 1 lists them all. The overall healthcare impact and projected peak sales of 2012-approved products are both rather limited. Many of these products (perhaps even a majority) are biobetter, me-too, or similar follow-on (more of much the same) products, and many are orphan products — thus inherently limited in terms of their innovation, novelty, and/or markets. The list of approved products does not include any likely blockbusters (defined as having a potential market of US$1 billion/year), and most of them appear unlikely to attain even average biopharmaceutical sales levels (~$250-300 million/year).