USA Life Sciences Database. Actualités médicales. The Life Sciences Report. BioMed Central | Gateways. PharmaTech 2012 Top Pharmaceutical Biotechnology Companies by JAZD Markets. AlacraStore.com - Credit Research, Earnings Call Transcripts, Market Research from S&P, Fitch, Moody's and D&B. Established and Emerging Biotech Clusters. About.com: BioMedTracker. Ceutical Products in the U.S. and European Markets - FDA Approvals in 2011 Review.
Discussion: There were 12 full approvals for biopharmaceutical products in 2011. All of the qualifying products were approved as biologics (BLAs), except for 1 drug (NDA; Erwinaze, grandfathered as a drug). Only 4 of the 12 (33%) approvals were for recombinant proteins, a low number and percentage. This included 3 monoclonal antibody-based products. Medical Advances/Novel Indications: A record number of biopharmaceuticals received approval for novel indications (diseases), including for indications for which no prior effective treatments were available and for indications for which there had been no new approvals for over a decade. But various approvals are more specific and limited than can be so simply described (Table 1), e.g., not for first-line use; and some of these products' sales are already much less than had been expected (e.g., Benlysta). Two products received approval for a cancer indications, following 1 in 2010 and none in 2007, 2008 or 2009 (3 in the past 5 years).