FDA approves first biosimilar product!
The “Biologics Price Competition and Innovation” act, appended to the Affordable Care Act* signed into law by President Obama in 2010, opened up the American market to biosimilars. The FDA recently issued market authorisation for the first generic version of a drug derived from biotechnology. With clinical tests demonstrating efficacy and safety results identical to those achieved by the original biomedicine, this new product is approved for the treatment of five conditions. Most notably, it will be administered to patients suffering from leukaemia or cancer requiring a bone marrow transplant. Costing on average 30% less than their brand-name equivalents, biosimilars could pave the way for billions of dollars in savings.
* otherwise known as Obamacare