OR WAIT null SECS
March 02, 2011
With a regulatory pathway for follow-on biologics, industry is wondering what FDA will do next.
The author provides an overview of QbD implmentation for biopharmaceuticals.
The authors outline the key decision points FDA must consider in putting forth a US regulatory pathway for biosimilars.
November 02, 2010
Today begins the two-day public hearing being held at FDA headquarters in Rockville, MD, to gain public in put on how to implement and regulate the follow-on biologics pathway that was cleared via President Obama's Biologics Price Competition and Innovation Act of 2009, which falls under the 2010 approved healthcare reform legislation.
October 19, 2010
Pfizer announced this his week that it had entered into a strategic global agreement for the worldwide commercialization with the Indian biotechnology company Biocon (Bangalore) for biosimilar versions of insulin and insulin analog products (e.g., recombinant human insulin, glargine, aspart, and lispro).
October 07, 2010
FDA to Hold Public Hearing on Biosimilars Legislation, And More.
September 16, 2010
The generic-drug company Actavis (Hafnarfjordur, Iceland) is considering acquiring a 51% stake in the biopharmaceutical company BioPartners Holdings (Barr, Switzerland) from Bioton, a Polish biotechnology company.
September 10, 2010
Director General of the European Generic Medicines Association (EGA), Greg Perry, has emphasised the need for EU biosimilar guidelines for monoclonal antibodies (mAbs), as well as a harmonised, global approach to biosimilars in general, at the agency's 8th International Symposium on Biosimilar Medicines.
September 09, 2010
Director General of the European Generic Medicines Association (EGA), Greg Perry, has emphasized the need for EU biosimilar guidelines for monoclonal antibodies (mAbs), as well as a harmonized, global approach to biosimilars in general, at the agency's 8th International Symposium on Biosimilar Medicines.
September 01, 2010
A Strengths, Weaknesses, Opportunities and Threats analysis of the biosimilars market is given.