Biosimilars: The Way Forward In the United States

Biosimilars: The Way Forward In the United States
Here is an important article about the biosimilars in the U.S. which was written by Dr. Lorna Speid, the President of Speid & Associates, Inc., a regulatory affairs and drug development expert consulting firm based in San Diego, California.
Biosimilars: The Way Forward In the United States
1. Background: The European Medicines Agency has been approving biosimilars since 2006. The situation is different in the United States. Although “copies” of originator biological medicines have been approved in the US since 2006, these have not been approved as biosimilars.
Biological medicines have been registered by two main pathways in the US. Some biological medicines were approved under the Food Drug and Cosmetics Act (low molecular weight heparins, growth factor, insulins), while others were approved under the Public Health Services Act (e.g., erythropoietin). These different mechanisms of approval in the US, provide unique opportunities for registration of biological medicines that do not exist in Europe. For instance, Enoxaparin, a low molecular weight heparin was registered as a generic under 505(j), the generic pathway. Consequently, this medicine is fully substitutable for the originator product. The 505(b)(2) route has also been used to register Omnitrope, a recombinant growth hormone.
The challenge in the US was how would “copies” of originator biological medicines registered under the Public Health Service Act via 351(a) be registered. There has been much discussion on this over the years. After years of arguing strongly that such “copies” could not be made due to safety concerns, the prohibitive costs to global healthcare systems made it imperative that these arguments be cast aside. What was previously perceived to be impossible has suddenly become do-able.  
See link for full article.http://www.biosimilarnews.com/biosimilars-the-way-forward-in-the-united-states?utm_source=rss&utm_medium=rss&utm_campaign=biosimilars-the-way-forward-in-the-united-states