FDA biopharmaceutical product approvals and trends in 2012

BioProcess International

Volumn 11, Issue 3, 2013, Pages 18-27

  Rader, Ronald A ^a  

^a BIOPHARMA: Biopharmaceutical Products in the US and European Marketsand   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AFLIBERCEPT; BIOSIMILAR AGENT; CARBOXYPEPTIDASE G2; FIBRIN GLUE; HAEMOPHILUS INFLUENZAE TYPE B VACCINE; HERPES ZOSTER IMMUNOGLOBULIN; IMMUNOGLOBULIN; MENHIBRIX; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; UNCLASSIFIED DRUG;

ARTICLE; BIOTECHNOLOGY; DRUG APPROVAL; DRUG INDUSTRY; DRUG MARKETING; FOOD AND DRUG ADMINISTRATION; HEALTH CARE; HEALTH CARE SYSTEM; SCORING SYSTEM; TREATMENT INDICATION;

EID: 84876388914     PISSN: 15426319     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Article

References (5)

1. Biologics Price Competition and Innovation Act of 2009. HR 3590-686; www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/ucm216146. pdf.
2. BIOPHARMA: Biopharmaceutical Products in the US and European Markets database. Biotechnology Information Institute: Rockville, MD; www.biopharma.com.
3. Rader RA. Biosimilars/Biobetters Pipeline Review; www.biosimilars.com.
4. FY 2012 Innovative Drug Approvals: Bringing Life-saving Drugs to Patients Quickly and Efficiently. US Food and Drug Admininstration: Rockville, MD, December 2012; www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/ UCM330859.pdf.
5. Rader RA. (Re)defining Biopharmaceutical. Nature Biotechnol. 26(7) 2008: 743-751; www.biopharma.com/biopharmacopeia/Redefining.pdf.