Statistics on BCS classification of generic drug products approved between 2000 and 2011 in the USA.
The Biopharmaceutics Classification system (BCS) classifies drug substances based on aqueous solubility and intestinal permeability. The objective of this study was to use the World Health Organization Model List of Essential Medicines to determine the distribution of BCS Class 1, 2, 3, and 4 drugs in Abbreviated New drug Applications (ANDA) submissions. To categorize solubility and intestinal permeability properties of generic drugs under development, we used a list of 61 drugs which were classified as BCS 1, 2, 3, and 4 drugs with certainty in the World Health Organization Model List of Essential Medicines. Applying this list to evaluation of 263 ANDA approvals of BCS drugs during the period of 2000 to 2011 indicated 110 approvals (41.8%) for Class 1 drugs (based on both biowaiver and in vivo bioequivalence studies), 55 (20.9%) approvals for Class 2 drugs, 98 (37.3%) approvals for Class 3 drugs, and no (0%) approvals for Class 4 drugs. The present data indicated a trend of more ANDA approvals of BCS Class 1 drugs than Class 3 or Class 2 drugs. Antiallergic drugs in Class 1, drugs for pain relief in Class 2 and antidiabetic drugs in Class 3 have received the largest number of approvals during this period.
Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, 7520 Standish Place, Rockville, Maryland 20855, USA. Anil.Nair@fda.hhs.gov
Anil K
AK
Nair
Om
O
Anand
Nam
N
Chun
Dale P
DP
Conner
Mehul U
MU
Mehta
Duong T
DT
Nhu
James E
JE
Polli
Lawrence X
LX
Yu
Barbara M
BM
Davit
D017277:Drug Approval / Q000706:statistics & numerical data*; D015195:Drug Design; D018954:Drugs, Essential / Q000737:chemistry / Q000145:classification* / Q000493:pharmacokinetics; D016568:Drugs, Generic / Q000737:chemistry / Q000145:classification* / Q000493:pharmacokinetics; D006801:Humans; D007408:Intestinal Absorption; D012995:Solubility; D013810:Therapeutic Equivalency; D014481:United States; D014486:United States Food and Drug Administration; D014944:World Health Organization
D018954:Drugs, Essential; D016568:Drugs, Generic