Stages IIi Multinational Clinical Trials Essay example
USFDA and Health Canada have established exclusive approval pathways for biosimilars, they are not identical copies of their originators but needs to show a highly similar structure and similar clinical efficacy, safety and immunogenicity to their approved reference biologics. The main goal is to approve biosimilars are to reduce the cost and make it available to the large population. Biosimilars also undergo for testing at all stages of drug development from analytical, non-clinical, and clinical, which is suggestively more than the small-molecule generic drugs but less requirement than new biologics. The US FDA is authorizing the biosimilars under the Biologic Price Competition and Innovation Act (BPCI) approved by the U.S. President Obama in the Parliament on March 23, 2010, and the FDA has issued guidance in the year 2012. BPCI Act makes an abbreviated licensure pathway for biological products revealed to be biosimilar to or interchangeable with the FDA’s approved reference product.
USFDA -Follow On biologics
The US FDA uses follow-on biologics (FOBs) term for biosimilars. Follow-on biologics authorization is subject to the biologic product and considered by the United States Food, Drug, and Cosmetic Act (US FD&C) or by the United States Public Health Service Act (US PHS). The FDA has an authority to authorize follow-on biologics under novel division 351(k) of the PHS Act. Biologic products which were authorized…