By Emily MacHale
July 5, 2016
The Biosimilar market is estimated to save the United States over $44 billion by 2024 when many branded biologics are coming off patent protection.
Slightly different from generics and biological reference products, biosimilars are complex in their manufacturing and data, leaving the FDA to confirm its’ safety and efficacy to pass regulations. Besides main differences of small versus large, stable versus sensitive, and complex versus simply structured, biosimilars tend to have more manufacturing tests and larger clinical trials in actual patients.
Biosimilars are yet to be approved by all 50 states, leaving the estranged topic hidden under the rug while currently making its’ way through Europe. When and will biosimilars stampede through the states and make their almost-famous appearance? It is thought that when biosimilars begin to flood the U.S. market, sales could likely be even higher than Europe has seen to date.
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