The increasing demand for medicines and other biologic products paved the way to the development of methods that can speed up its production in order to meet the needs of its consumers. One of which is the utilization of biosimilar product, which is defined by the U.S. Food and Drug Administration (FDA) as ‘a biological product that is approved based on a showing that it is highly similar to an FDA-approved biological product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product’.
The emergence of biosimilars is known to be in accordance with the Patient Protection and Affordable Care Act (Affordable Care Act) signed by US President Barack Obama on March 23, 2010. This law was promulgated in order to establish an expedited licensure pathway for biological products that exhibited no significant difference, in terms of safety and efficacy, with an existing FDA-licensed biological product (U.S. Food and Drug Administration, 2016).
Pharmaceutical companies venturing on the production of biosimilars have envisioned market opportunities and have found some interesting advantages of this undertaking. By the year 2020, biologics with estimated sales of $100 billion will lose its patent protection. Since the development of an original biological product entails a complex process and expensive costs, several companies tend to produce biosimilars, instead. Biosimilars are thought to have greater chances of making it to the market, therefore less risky than branded biologics. Aside from this, investment in biologics is much higher compared to that of biosimilars with relatively lower probability of success. In fact, as of December 2012, it was estimated that the average cost of research and development (R&D) of new drugs may reach $1.9 billion with only 1/10 probability of commercial success after approximately 13.5 years of R&D (Blackstone & Joseph, 2013).
The following will give us an overview of some of the biosimilars which have been available in the market, according to FDA’s Center for Drug Evaluation and Research (U.S. FDA Center for Drug Evaluation and Research , 2016).
- Approval Date: September 23, 2016
- Reference Product: Humira by AbbVie Inc.
- Indications (for adult patients):
- moderately to severely active rheumatoid arthritis;
- active psoriatic arthritis;
- active ankylosing spondylitis (an arthritis that affects the spine);
- moderately to severely active Crohn’s disease;
- moderately to severely active ulcerative colitis; and
- moderate to severe plaque psoriasis
- Indications (for pediatric patients – 4 years old and above)
- moderately to severely active polyarticular juvenile idiopathic arthritis
- Approval Date: August 30, 2016
- Reference Product: Enbrel by Amgen, Inc.
- Indications (for adult patients):
- moderate to severe rheumatoid arthritis, either as a standalone therapy or in combination with methotrexate (MTX) moderately to severely active rheumatoid arthritis;
- active psoriatic arthritis, including use in combination with MTX in psoriatic arthritis patients who do not respond adequately to MTX alone;
- active ankylosing spondylitis (an arthritis that affects the spine); and
- chronic moderate to severe plaque psoriasis in adult patients (18 years or older) who are candidates for systemic therapy or phototherapy
- Indications (for pediatric patients – 2 years old and above)
- moderate to severe polyarticular juvenile idiopathic arthritis
- Approval Date: April 5, 2016
- Reference Product: Remicade by Janssen Biotech, Inc.
- adult patients and pediatric patients (ages six years and older) with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy;
- adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy;
- patients with moderately to severely active rheumatoid arthritis in combination with methotrexate;
- patients with active ankylosing spondylitis (arthritis of the spine);
- patients with active psoriatic arthritis;
- adult patients with chronic severe plaque psoriasis
- Approval Date: March 6, 2015
- Reference Product: Neupogen by Amgen, Inc.
- patients with cancer receiving myelosuppressive chemotherapy;
- patients with acute myeloid leukemia receiving induction or consolidation chemotherapy;
- patients with cancer undergoing bone marrow transplantation;
- patients undergoing autologous peripheral blood progenitor cell collection and therapy
- patients with severe chronic neutropenia
- Blackstone, E. A., & Joseph, P. F. (2013). The Economics of Biosimilars. American Health and Drug Benefits , 469 – 478.
- U.S. FDA Center for Drug Evaluation and Research . (2016, October 23). Retrieved November 3, 2016, from U.S. Food and Drug Administration: http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/UCM439049.pdf
- U.S. Food and Drug Administration. (2016, May 10). Retrieved November 3, 2016, from U.S. Food and Drug Administration: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/