http://www.manostaxx.com

FDA: Biosimilars

TRADELABOR has more than 20 years of experience in the control and treatment of air, working with an experienced and qualified technical staff and with the most advanced technology in this area, which together guarantee the quality of the services provided.

 

 

Biosimilars are safe, effective treatment options

Congress, through the Biologics Price Competition and Innovation Act (BPCI Act) of 2009, created an abbreviated licensure pathway for biological products that are demonstrated to be biosimilar to or interchangeable with an FDA-approved biological product. This pathway was established as a way to provide more treatment options, increase access to lifesaving medications, and potentially lower health care costs through competition.

FDA requires biosimilar and interchangeable biological products meet the Agency’s rigorous approval standards. That means patients and health care professionals will be able to rely upon the safety and effectiveness of the biosimilar or interchangeable product, just as they would the reference product.

Visit the pages below to learn more:

 

Continue at: https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/biosimilars

 

The text above is owned by the site above referred.

Here is only a small part of the article, for more please follow the link

Also see:

www.manostaxx.com

 

Manostaxx
Manostaxx – Industrial Management Consulting

Leave a Reply

Your email address will not be published. Required fields are marked *