scholarly journals The quest for generic biotechnology pharmaceuticals in the USA

2005 ◽  
Vol 11 (3) ◽  
Author(s):  
Thomas J Kowalski ◽  
Pamela Fekete ◽  
Nne-Marie C Yvon
Keyword(s):  
Growth Hormone ◽  
Pharmaceutical Industry ◽  
Human Growth Hormone ◽  
First Generation ◽  
Patent Protection ◽  
Human Growth ◽  
Regulatory Framework ◽  
The Usa ◽  
Biotechnology Products

As patent protection expires on the first generation of biotechnology products, such as human growth hormone and erythropoietin, there is an impetus for the development and marketing of generic equivalents. Currently there is no statutory or regulatory framework governing generic biotechnology products. This paper explores the potential solutions that have been suggested by members of the pharmaceutical industry and government, both in the USA and internationally.

scholarly journals Biogenerics 2007: How far have we come?

2008 ◽  
Vol 14 (1) ◽  
Author(s):  
John Tucker ◽  
Seth Yakatan ◽  
Stan Yakatan
Keyword(s):  
Growth Hormone ◽  
Human Growth Hormone ◽  
Generic Drug ◽  
Patent Protection ◽  
Business Models ◽  
Recombinant Human Growth Hormone ◽  
Human Growth ◽  
European Patent ◽  
Commercial Space ◽  
Commercial Opportunity

The recent approval of a follow-on version of Pfizer's Genotropin (recombinant human growth hormone) signalled the beginning of the end of an era in which biopharmaceuticals enjoyed immunity from competition even after expiration of their patent protection. This paper describes many of the key scientific challenges facing the nascent ‘biogenerics’ industry and the evolving regulatory framework that will shape its competition with innovator companies. We describe key differences between the biogeneric and traditional generic drug business models and the M&A activity that been undertaken in pursuit of the expertise and resources needed to be competitive in this commercial space. We conclude with a discussion of the commercial opportunity presented by recent and upcoming European patent expirations and the challenges presented by competition from second-generation innovator products.

LIPOLYTIC ACTIVITY OF ENZYME DIGESTED HUMAN GROWTH HORMONE

1965 ◽  
Vol 49 (3_Suppl) ◽  
pp. S143
Author(s):  
Zvi Laron ◽  
Avivah Kowadlo-Silbergeld
Keyword(s):  
Growth Hormone ◽  
Human Growth Hormone ◽  
Lipolytic Activity ◽  
Human Growth

The minimal amino acid sequence of the insulin-potentiating fragments of human growth hormone: its mechanism of action

Diabetes ◽  
1980 ◽  
Vol 29 (10) ◽  
pp. 782-787 ◽  
Author(s):  
F. M. Ng ◽  
J. Bornstein ◽  
C. E. Pullin ◽  
J. O. Bromley ◽  
S. L. Macaulay
Keyword(s):  
Growth Hormone ◽  
Amino Acid ◽  
Amino Acid Sequence ◽  
Human Growth Hormone ◽  
Mechanism Of Action ◽  
Human Growth

Stable Production of a Human Growth Hormone Antagonist from CHO Cells Adapted to Serum-Free Suspension Culture

1999 ◽  
Vol 15 (3) ◽  
pp. 336-346 ◽  
Author(s):  
R. Haldankar ◽  
J.J. Kopchick ◽  
D. Ridgway
Keyword(s):  
Growth Hormone ◽  
Suspension Culture ◽  
Human Growth Hormone ◽  
Cho Cells ◽  
Human Growth ◽  
Serum Free ◽  
Stable Production ◽  
Serum Free Suspension
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