Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues.
Biologics are isolated from a variety of natural sources - human, animal, or microorganism - and may be produced by biotechnology methods and other cutting-edge technologies. Gene-based and cellular biologics, for example, often are at the forefront of biomedical research, and may be used to treat a variety of medical conditions for which no other treatments are available.
CBER reviews applications for new products, new indications for already approved products, and product-related changes. This requires evaluating submitted scientific and clinical data to determine whether the product meets CBER's standards for approval. After a thorough assessment of the data, CBER makes a decision based on the risk-benefit for the intended population and the product's intended use. CBER's authority resides in the Public Health Service Act and in specific sections of the Food Drug and Cosmetic Act.
Here is a list of 2023 Biological License Application Approvals
| Tradename/Proper Name | Manufacturer/ License Number |
Approval Date | ||
|---|---|---|---|---|
| ADZYNMA ADAMTS13, recombinant-krhn |
Takeda Pharmaceuticals U.S.A., Inc. Cambridge, MA 02142 Lic. # 1898 |
11/09/2023 | ||
| IXCHIQ Chikungunya Vaccine, Live |
Valneva Austria GmbH Valneva USA, Inc. Bethesda, MD 20814 Lic. # 1909 |
11/09/2023 | ||
| PENBRAYA Meningococcal Groups A, B, C, W, and Y Vaccine |
Pfizer Ireland Pharmaceuticals Pfizer Inc. Pearl River, NY 10965 Lic. # 2060 |
10/20/2023 | ||
| Elecsys HTLV- I/II Elecsys HTLV-I/II |
Roche Diagnostics Indianapolis, IN 46250 Lic. # 2305 |
10/17/2023 | ||
| Source Plasma | DB Biologics LLC Research Triangle Park, NC 27709 Lic. # 2327 |
09/13/2023 | ||
| ABRYSVO Respiratory Syncytial Virus Vaccine |
Pfizer Inc. Collegeville, PA 19426 Lic. # 2001 |
08/21/2023 | ||
| BALFAXAR prothrombin complex concentrate, human-lans |
Octapharma Pharmazeutika Produktionsges.m.b.H. Octapharma USA, Inc. Paramus, NJ 07652 Lic. # 1646 |
07/21/2023 | ||
| CYFENDUS Anthrax Vaccine Adsorbed, Adjuvanted |
Gaithersburg Inc. Gaithersburg, MD 20879 Lic. # 2089 |
07/20/2023 | ||
| ROCTAVIAN valoctocogene roxaparvovec-rvox |
BioMarin Pharmaceutical Inc. CA 94949 Lic. # 1649 |
06/29/2023 | ||
| LANTIDRA donislecel-jujn |
CellTrans Inc. Chicago, IL 60612 Lic. # 2213 |
06/28/2023 | ||
| ELEVIDYS delandistrogene moxeparvovec-rokl |
Sarepta Therapeutics, Inc. Cambridge, MA 02142 Lic. # 2308 |
06/22/2023 | ||
| Elecsys HIV Duo Elecsys HIV Duo |
Roche Diagnostics Indianapolis, IN 46250 Lic. # 2305 |
06/13/2023 | ||
| ABRYSVO Respiratory Syncytial Virus Vaccine |
Pfizer Inc. Collegeville, PA 19426 Lic. # 2001 |
05/31/2023 | ||
| VYJUVEK beremagene geperpavec-svdt |
Krystal Biotech, Inc. Pittsburgh, PA 15203 Lic. # 2301 |
05/19/2023 | ||
| AREXVY Respiratory Syncytial Virus Vaccine, Adjuvanted |
GlaxoSmithKline Biologicals Rockville, MD 20850 Lic. # 1617 |
05/03/2023 | ||
| VOWST fecal microbiota spores, live-brpk |
Seres Therapeutics, Inc. Cambridge, MA 02139 Lic. # 2262 |
04/26/2023 | ||
| OMISIRGE omidubicel-onlv |
Gamida Cell Ltd. Boston, MA 02116 Lic. # 2223 |
04/17/2023 | ||
| Source Plasma | Clinical Research Technologies, Inc. (CRT) El Cajon, CA 92021 Lic. # 2316 |
02/23/2023 | ||
| ALTUVIIIO antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl |
Bioverativ Therapeutics, Inc. Bridgewater, NJ 08807 Lic. # 2078 |
02/22/2023 | ||
| Source Plasma | Join Parachute, LLC Austin, TX 78704 Lic. # 2273 |
01/25/2023 | ||
| Source Plasma | Olgam Life LLC Brooklyn, NY 11238 Lic. # 2287 |
01/19/2023 | ||
| Source Plasma | Pelican Plasma Shreveport, LA 71106 Lic. # 2283 |
01/17/2023 |
