Biological products are approved for marketing in the United States under the provisions of the Public Health Service (PHS) Act. The Act requires biologic manufacturers to obtain a license to sell the product in interstate commerce.
The FDA's Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) share responsibility for the regulation of biologics. CBER regulates allergenics, blood and blood components, devices developed to prevent contamination of blood, blood components and cellular product, software used to collect blood and blood, gene therapy, human tissues, cellular products, vaccines, and xentranspalantation products (live animal organs, cells or tissues used to treat human diseases.
The CDER has responsibility for regulating monoclonal antibodies for use in vivo, proteins extracted from plants, animals or microorganisms, and other non-vaccine therapeutic immunomotherapies.
While it has some similarities to a New Drug Application (NDA), a BLA has its own unique set of requirements.
A biologics license application contains details on the chemistry, pharmacology, source materials, manufacturing processes, labeling and medical affects of the biologic product as well as data from clinical studies. If the information provided meets FDA requirements, the application is approved and a license is issued allowing the firm to market the product.
Since they contain information from pre-clinical toxicology studies to phase 3 clinical trial data, a BLA application may run to thousands of pages long.
Downloadable forms, instructions, and a description of the process for submitting a BLA information on electronic submissions are available on the CBER section of the FDA website.
The FDA approved 10 BLAs in 2011 including Albumin (human), Hemacord (Hematopoietic Progenitor Cells -HPC-C), Ultraqual HBV PCR assay (Hepatitis B Virus), Anascorp Centruroides (scorpion immune F(ab')2 equine injection), two types of source plasma, Spherusol Coccidioides immitis (spherule-derived skin test antigen), LaViv Azficel-T (for removal of fold wrinkles), and Adenovirus Vaccine Live Oral Type 4 and Type 7 (immunization against febrile acute respiratory disease).
BLA Submissions in the News
Ethicon Submits Biologic License Application to the FDA for the Fibrin Pad -- Somerville, NJ, Nov. 18, 2010 - Ethicon, Inc., a worldwide leader in surgical care, announced today that the company has submitted a Biologic License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the Fibrin Pad, a novel product candidate that combines Ethicon's biomaterials and plasma-derived biologics (Human Fibrinogen and Human Thrombin), to aid in stopping soft tissue bleeding during surgery.
EUSA Pharma submits Erwinase BLA -- EUSA Pharma has submitted a biologics license application (BLA) to the US Food and Drug Administration (FDA) for Erwinase (L-asparaginase derived from Erwinia chrysanthemi) for use in the treatment of acute lymphoblastic leukemia in patients with hypersensitivity to E Coli-derived asparaginase. -- PBR Regulatory Affairs, November 10, 2010
ThromboGenics Submits Biologics License Application for Ocriplasmin to the U.S. FDA -- ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on developing innovative ophthalmic medicines, today announces that it has submitted a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for ocriplasmin Intravitreal Injection, 2.5 mg/mL, for the treatment of symptomatic VMA including macular hole.
The BLA submission, which includes data from two pivotal Phase III trials involving 652 patients in the U.S. and Europe, will undergo a standard review by the FDA. In October 2011, the European Medicines Agency accepted for review ThromboGenics' Marketing Authorisation Application (MAA) for ocriplasmin for the same indication. -- PRNewswire, December 23, 2011