Biosimilars : The promise to mitigate health care costs
Biosimilars have distinct characteristics compared with generic drugs , which creates unique challenges and opportunities , for example , as it relates to reimbursement
Jorge García PharmD MS MHA MBA FACHE Baptist Health South Florida Miami Cancer Institute – Lynn Cancer Institute Miami , FL , USA
The simplest forms of biologic drugs entered the US market in the 1970s and primarily consisted of blood products and vaccines . The rise of cloning and gene expression technology enabled biosynthesis of genetically modified organisms , which allowed the production of increasingly complex biologic molecules , including recombinant human insulin in 1982 , the first FDA-approved monoclonal antibody and the entry of recombinant monoclonal antibodies in cancer treatment in 1997 . 1 Since then , biologics have revolutionized the treatment of serious medical conditions in the US . 2 However , the high cost associated with biologics along with increasing biologic utilization over the years have led to sharp increases in the overall health care cost curve .
Factors increasing utilization of biologics
• Population growth
• Increasing number of biologics available
• Improved biologics side effects profile – Earlier initiation of therapy – Longer tolerability – Allowing concomitant lines of therapy
• Improved efficacy
• Improved survival rate and longer duration of therapy
• Improved cure rate – Biologic utilization on secondary and / or unrelated diseases .
As a drug category , biologics show an increasing cost rate relative to overall drug cost . Overall drug cost remains a top public concern in the US .
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