NY Times October 18, 2010, 12:05 pm
Pfizer Makes Move Into Biologic Drugs
By ANDREW POLLACK
Making a new move into the fledgling market for generic biotech drugs, pharmaceutical giant Pfizer has acquired worldwide rights to sell human insulin and insulin analogs being developed by Biocon, one of India’s largest biotech companies. (Read More: http://prescriptions.blogs.nytimes.com/2010/10/18/pfizer-makes-move-into-biologic-drugs/) . . . that since the pathway for biogenerics has not yet been established, Biocon plans to conduct a phase 3 clinical trial of its insulin and to seek approval under an existing pathway known as rule 505(b)(2).
