nesielheum
11-18-2006, 04:44 AM
I am always a bit miffed at the cost of some of the newer biological drugs that come to market. However considering the cost-to-launch or how much it costs organizations to bring these drugs through Phase I, Phase II, Phase III clinical trials and then final approval, I am not too surprised at the need to demand such high $$$s at least during the first few years until the expiration of patents.
FDAnews Drug Daily Bulletin
Monday, Nov. 20, 2006
Vol. 3, No. 227
BIOTECHNOLOGY DEVELOPMENT COSTS TOP $1.2 BILLION PER PRODUCT
The average cost of developing a new therapeutic biotechnology product
is more than $1.2 billion, including the costs of drugs that fail in
testing and the time associated with bringing these products to
market, according to a new study by the Tufts Center for the Study of
Drug Development.
The study's authors defined a biotechnology product as "any
therapeutic biological compound, including recombinant proteins,
monoclonal and polyclonal antibodies, antisense oligonucleotides,
therapeutic genes and recombinant and DNA vaccines," as distinguished
from "traditional" pharmaceuticals.
The $1.2 billion figure includes an average out-of-pocket cash cost of
$198 million for preclinical development, which rises to $615 million
when fully capitalized, and an average out-of-pocket cash cost of $361
million for clinical development, which rises to $626 million when
fully capitalized.
Capitalization increases biopharmaceutical costs relative to
traditional pharmaceutical costs because of a longer development
timeline and a higher cost of capital, the study found. A new biotech
product takes 97.7 months on average to make its way through clinical
development and regulatory review, about 8 percent longer than for
traditional pharmaceuticals. On the other hand, biopharmaceuticals
have an overall clinical approval success rate of 30.2 percent, as
opposed to 21.5 percent for traditional drug pipelines.
I still wish these drugs were cheaper, but I can appreciate the layout of vast sums of capital and an organizations wish to recoup expenses.
FDAnews Drug Daily Bulletin
Monday, Nov. 20, 2006
Vol. 3, No. 227
BIOTECHNOLOGY DEVELOPMENT COSTS TOP $1.2 BILLION PER PRODUCT
The average cost of developing a new therapeutic biotechnology product
is more than $1.2 billion, including the costs of drugs that fail in
testing and the time associated with bringing these products to
market, according to a new study by the Tufts Center for the Study of
Drug Development.
The study's authors defined a biotechnology product as "any
therapeutic biological compound, including recombinant proteins,
monoclonal and polyclonal antibodies, antisense oligonucleotides,
therapeutic genes and recombinant and DNA vaccines," as distinguished
from "traditional" pharmaceuticals.
The $1.2 billion figure includes an average out-of-pocket cash cost of
$198 million for preclinical development, which rises to $615 million
when fully capitalized, and an average out-of-pocket cash cost of $361
million for clinical development, which rises to $626 million when
fully capitalized.
Capitalization increases biopharmaceutical costs relative to
traditional pharmaceutical costs because of a longer development
timeline and a higher cost of capital, the study found. A new biotech
product takes 97.7 months on average to make its way through clinical
development and regulatory review, about 8 percent longer than for
traditional pharmaceuticals. On the other hand, biopharmaceuticals
have an overall clinical approval success rate of 30.2 percent, as
opposed to 21.5 percent for traditional drug pipelines.
I still wish these drugs were cheaper, but I can appreciate the layout of vast sums of capital and an organizations wish to recoup expenses.