Biologic Drug Report - New Biologics / Biologic Pipeline

More than 300 biological drugs and vaccines are either in clinical trials or awaiting action by the U.S. Food and Drug Administration -- a number that exceeds the 250+ biologics approved by the regulatory agency over the years.

Here are some of the biologics most recently approved by the U.S. Food and Drug Administration, as well as those awaiting action.

Name of Biologic	Use
Gardasil	Vaccine for preventing diseases caused by the human papilloma virus (ie, genital warts and cervical cancer)
Lucentis	Treatment for patients with wet age-related macular degeneration.
Vectibix	Treating metastatic colorectal cancer after disease progression or following chemotherapy.
Elaprase	Treating Hunter syndrome, a rare, life threatening, genetic disorder.
Myozyme	Treating Pompe disease, a rare, life threatening genetic disorder that disables the heart and muscles.
Omnitrope	Treating human growth hormone deficiency in pediatric patients and adults.

Here are some of the biologics for which Biologics License Applications have been filed with the U.S. Food and Drug Administration and are awaiting action on approval.

Name of Biologic	Use
Provenge	Treating metastatic, hormone-refractory prostate cancer.
Mircera	Treating anemia in patients with chronic kidney disease.
rhThrombin	An aid to controlling bleeding during surgery.
Solaris	Treating PNH, a rare and life-threatening form of hemolytic anemia.
Ipilimumab	Treating metastatic melanoma.

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Last Updated: 01/14/2007