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.
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.
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 email@example.com
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.
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|
Courtesy of DrugPatentWatch.com