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According to our Report, “Global Biosimilar Market Outlook 2022”, for many years various pharmaceutical companies have been making efforts to introduce their biosimilar products in the US. However, the stringent regulatory scenario and patent protection of biologics prevented them from launching their products. After years of debate and regulatory hurdles, a milestone was achieved on March 6, 2015, when the FDA approved the first biosimilar product, Zarxio, in US. This product is a biosimilar to Amgen’s Neupogen, which was originally licensed in 1991. This biosimilar is approved for the same indications as Neupogen.
 
Furthermore, in April 2016, the FDA approved second biosimilar, known as Inflectra. Inflectra is biosimilar to Janssen Biotech, Inc.’s Remicade (infliximab), which was originally licensed in 1998. This biosimilar is intended for the treatment of Crohn’s disease, ulcerative colitis, and rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis. Similarly, in August 2016, the USFDA approved another biosimilar, Erelzi, for multiple inflammatory diseases. Erelzi is manufactured by Sandoz and is a biosimilar to Enbrel (etanercept), which was originally licensed in 1998.
 
These products have been approved through the pathway created by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) that was implemented as a part of the Affordable Care Act in March 2010. The BPCI Act created an abbreviated licensure pathway for biological products shown to be biosimilar to or interchangeable with an FDA-licensed biological product, called the reference product. These approved biosimilars along with others in pipeline, in the future, are expected to lower the cost burden on the patient population as well as the American Healthcare System as they cost less than the originators.
 
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