Biologics include a growing class of modern medicines, produced in living systems, that provide new options for patients with complex diseases, such as breast cancer1 and autoimmune disorders.2 At the same time, biologics’ high research and development costs3 and their sophisticated and resource-intensive manufacturing processes4 mean they are significantly more expensive than conventional pharmaceuticals.5 This results in a heavy financial burden to our healthcare system and on patients.6 With the introduction of biosimilars to our healthcare system, we could see measurable cost savings and greater patient accessibility to these ongoing therapeutic treatments for chronic diseases.6
WHAT IS A BIOSIMILAR?
In simple terms, a biosimilar is a biologic medicine that has been proven, through a rigorous regulatory process, to have a high similarity to the reference biologic medicine (also referred to as the originator or original biologic). In fact, a biosimilar’s primary amino acid sequence matches that of the reference biologic with only minor differences in clinically inactive components.7 Biosimilars are approved by regulatory authorities to meet extremely high standards for similarity in quality, efficacy, and safety to the reference biologic.8
Biosimilars, like all biologics, differ from small-molecule, chemically synthesized drugs and generics, as they are:
- Typically made in living systems or organisms9
- Protein-based, rather than chemical-based medicines10
- Larger and more complex in molecular structure9
- Produced using commercial biotechnology techniques9
Biosimilars must demonstrate therapeutic equivalence to the reference biologic within the pre-defined equivalence margin.8
Biosimilars are poised to significantly benefit U.S. patients and healthcare organizations by:
- Costing an estimated 20% to 30% less than reference biologics1
- Saving an estimated $20 billion per year based on the sales of reference biologics11
- Reducing dependence on reference biologics for Medicare and Medicaid programs, resulting in an estimated savings of $3 billion for Medicare Part B alone by 201612
HOSPIRA’S COMMITMENT TO BIOSIMILARS
Hospira, the first U.S. company to provide biosimilars in Europe and Australia, has been driving global policies in support of biosimilars. As Biosimilars usage grows and policy evolves, there are frequent updates to news coverage on Biosimilars.
We recognize the importance of continually developing new cost-effective solutions in an effort to provide greater value to healthcare and patients. Learn more about biosimilars and Hospira’s commitment to the future of healthcare.
- Hirsch BR, Lyman GH. Biosimilars: are they ready for primetime in the United States? J Natl Compr Canc Netw. 2011;9: 934–943.
- Scheinberg MA, Kay J. The advent of biosimilar therapies in rheumatology – “O Brave New World. Nat Rev Rheumatol. 2012;8:430–436.
- Federal Trade Commission. Emerging health care issues: follow-on biologic drug competition. June 2009 Report. Available at: http://www.ftc.gov/os/2009/06/P083901biologicsreport.pdf. Accessed October 2, 2013.
- Schellekens H. Biosimilar therapeutics – what do we need to consider? NDT Plus. 2009;2 (Suppl 1):i27–i36.
- Engelberg AB, et al. Balancing innovation, access, profits - market exclusivity for biologics. N Engl J Med. 2009;361(20):1917–1919.
- Shapiro R, et al. The potential American market for generic biological treatments and the associated cost savings. February 2008. Available at: http://www.sonecon.com/docs/studies/0208_GenericBiologicsStudy.pdf. Accessed October 2, 2013.
- U.S. Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product. Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf. Accessed October 17, 2013.
- Weise M, et al. Biosimilars: what clinicians should know. Blood. 2012;120:5111–5117.
- US Food and Drug Administration. Information for consumers (biosimilars). Available at: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/
ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm241718.htm. Accessed October 2, 2013.
- Kotlikoff LJ. Stimulating innovation in the biologics industry: A balanced approach to marketing exclusivity. September 2008. Available at: http://people.bu.edu/kotlikof/New%20Kotlikoff%20Web%20Page/Kotlikoff_Innovation_in_Biologics21.pdf. Accessed October 17, 2013.
- Generic Pharmaceutical Association; Feb. 1, 2013. New Grant Thornton study shows immediate need for biosimilar competition [press release]. Available at: http://www.gphaonline.org/gpha-media/press/gpha-press-granthornton. Accessed October 2, 2013.
- Ventola CL. Biosimilars part 2: potential concerns and challenges for P&T committees. P&T;38:329–335.