Generic Biologics: How to Compete

Guest content from John Avellanet, managing director and principal of Cerulean Associates:

Follow-on biologics are a foregone conclusion in the US. Too much money is at stake. The more difficult discussion starts with how to prepare your company to compete.

Science Succumbs to Dollars
The financial pull on reimbursement organizations and the constituent push on Congress for less expensive biotechnology treatments will inevitably lead to a regulatory approval pathway for so-called follow-on or generic biologics.
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February 25, 2008

25 Feb 2008

BIO's website hacked?

Browsing around the Biotechnology Industry Organization site late last night, I was surprised to find that BIO’s press release section had been hacked. No evidence of tampering elsewhere on the site, but all the news releases have been tagged by the hackers.

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February 18, 2008

18 Feb 2008

Upcoming talk: Forget everything you thought you knew about biotechnology entrepreneurship

I’ll be at Rutgers on February 29th, giving a talk on biotechnology entrepreneurship. My objective is to dispel the popular notions about how biotechnology entrepreneurship occurs, and to provide case studies demonstrating the diversity of methods by which biotechnology entrepreneurs start and build their businesses. I’ll also provide some case studies of significant mis-steps, with the intention of demonstrating that risks can come from many sources.

For more information, visit http://aesop.rutgers.edu/~dgenes/events.html or contact the organizers at dgenes@eden.rutgers.edu

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February 10, 2008

10 Feb 2008

An appeal for generic biologic legislation

The following appeal for generic biologic legislation was sent in from Insmed via youtube.

I’ve posted previously on the challenges of developing a framework for generic biologic approvals and questioned how much we can really expect to save. In the editorial for the upcoming issue of the Journal of Commercial Biotechnology, I argue that the United States is unlikely to lead in generic biologic regulation.

Got any ideas to overcome the challenges? I’d love to post them here or at the Journal of Commercial Biotechnology.

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February 4, 2008

04 Feb 2008

Drug Patent Expirations in February 2008

Courtesy of DrugPatentWatch.com:

Drug Patent Expirations in February 2008
*Drugs may be
covered by multiple patents

Tradename	Applicant	Generic Name	Patent Number	Patent Expiration
CAMPTOSAR	Pfizer Inc	irinotecan hydrochloride	4,604,463	FEB 20,2008
CIPRO HC	Alcon	ciprofloxacin hydrochloride; hydrocortisone	4,844,902	FEB 11,2008
CIPRODEX	Alcon	ciprofloxacin; dexamethasone	4,844,902	FEB 11,2008
DEPOCYT	Pacira Pharms Inc	cytarabine	6,071,534	FEB 18,2008
DEPODUR	Pacira Pharms Inc	morphine sulfate	6,071,534	FEB 18,2008
FOSAMAX	Merck	alendronateLe but de poker pacific. sodium	4,621,077	FEB 06,2008
FOSAMAX PLUS D	Merck	alendronate sodium; cholecalciferol	4,621,077	FEB 06,2008
INSPRA	Gd Searle Llc	eplerenone	4,559,332	FEB 11,2008
LOTEMAX	Pharmos	loteprednol etabonate	4,996,335	FEB 26,2008
TESLASCAN	Ge Healthcare	mangafodipir trisodium	4,992,554	FEB 12,2008