FDA Focuses On Harmonization With The Launch Of Generic Drug Cluster
As Agency Calls For Scientific And Regulatory Alignment Globally
To improve common standards for global development for generics and access to generics, FDA has launched the Generic Drug Cluster through the Global Generic Drug Affairs team established by the FDA’s Office of Generic Drugs. The agency has listed objectives through which it aims to increase scientific alignment among leading generic drug regulatory agencies.
You may also be interested in...
Aset of “internationally harmonised guidelines on scientific and technical standards for generic drugs” should be developed through the International Council forHarmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), according to a proposal that has been put forward by the US Food and Drug Administration (FDA).
Pfizer reported double-digit growth in its biosimilars and sterile injectables segments, as the company indicated that it would take a more “opportunistic” approach to its biosimilars business in future. The company has also revised its overall 2021 financial guidance as it expects better numbers on the back of its COVID-19 vaccine business.
BioXpress Therapeutics and Abzena, two service providers with expertise in biosimilar development, have partnered to support biosimilar development for third party customers. The companies plan to offer a “flexible and innovative approach from small scale biosimilar development through to large scale manufacturing.”