Since the passage of H.R. 3590 Sec. 7002 in 2009, commonly known as the BPCIA, the FDA has licensed only nine products. The FDA has issued, several guidelines, as a draft and as final, to help the industry better understand the current thinking of the FDA on demonstrating biosimilarity, the primary element of licensing a product as a biosimilar or interchangeable biosimilar. The slow entrance of biosimilars into US market, along with a cost of $100-250 Million and 7-8 years into development are untenable and need addressing and appropriate changes made to the regulatory guidance documents of the FDA to enable the BPCIA to benefit the American patients as widely published by the Author. The review summarizes the changes needed in the FDA guidance to expedite the approval of biosimilars, as well as their utilization by patients.The FDA has recognized the need for changes to the FDA guidance, as communicated by the Commissioner of FDA, Dr. Scott Gottlieb, expressing the willingness of the FDA to respond to the urgent needs to reinterpret the FDA’s guidelines for the approval, as well as wider adoption of biosimilars.
The BPCIA defines and mandates the information required for licensure of biological products as biosimilar or interchangeable.
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