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SANDOZ, a division of Novartis, is one of the largest manufacturers of generic pharmaceuticals and biosimilars in the United States. Sandoz has been at the forefront of biotechnology development and innovation for the past 70 years, developing, manufacturing, and distributing competitive, high-quality pharmaceuticals. By actively investing in the future of biosimilars, Sandoz continues to deliver on its purpose to help millions of patients in immunology, oncology, endocrinology and other underserved therapeutic areas to access biologic medicines sustainably and affordably.
A SCIENCE-BASED APPROACH TO BIOSIMILAR DEVELOPMENT
As the pioneer and a global leader in biosimilars and the first to bring a biosimilar medicine to the US, Sandoz is committed to increasing access for patients by bringing high-quality, more affordable, potentially life-changing biologic treatments to market.
Biosimilars are FDA-approved biologics that have undergone an extensive regulatory evaluation and approval process proving they match the reference medicine in terms of quality, safety and efficacy.,[ii] Development of these high-quality, more affordable biologic treatments is fundamentally based on ensuring high similarity of important parameters such as molecular structure, bioactivity, pharmacokinetics, pharmacodynamics.[iii]
Confirmatory clinical studies have repeatedly shown that there is no clinically meaningful difference in terms of safety, purity and potency between biosimilars and their reference medicines,[iv] meaning that a patient can expect an equivalent treatment outcome at a more affordable price point.
Once a biosimilar is approved for one indication, extrapolation based on totality of evidence can allow expansion of its use to other indications for which the reference biologic is approved.
Learn more about the biosimilar development process here.
ZARXIO® AND ZIEXTENZO®
Biosimilars can expand patient access to biologic medicines, increase healthcare savings[v] and have an important role in creating sustainability for overburdened health systems. For example, the availability of biosimilar filgrastim generated approximately $1.1 billion in savings to the US healthcare system from 2016 to 2019, with Sandoz Zarxio® driving the majority of the market.
As a result of the successful adoption of Zarxio® into clinical practice, it became the first biosimilar to surpass its reference biologic in market share. Moreover, with the launch of Ziextenzo® (pegfilgrastim-bmez) in November 2019, Sandoz now has four US-approved biosimilars, and was the first company to offer long- and short-acting filgrastim biosimilar treatment options.
While biosimilars continue to gain momentum in the US, many challenges remain that hinder patient access to these life-changing biologic medicines and undercut patients and healthcare systems from realizing the full savings potential of biosimilars.
Sandoz is committed to working with all stakeholders to address barriers impacting biosimilar adoption and to improve patient access to more affordable, high-quality and potentially life-changing biologic treatments.
Learn more about Sandoz biosimilars here.
US Food and Drug Administration. Biologic product definitions. https://www.fda.gov/drugs/biosimilars/biosimilar-development-review-and-approval.
[ii] US Department of Health and Human Services. Scientific considerations in demonstrating biosimilarity to a reference product: guidance for industry. April 2015. https://www.fda.gov/download s/drugs/guidances/ucm291128.pdf.
[iii] US Food and Drug Administration. FDA Arthritis Advisory Committee Meeting: June 6, 2016. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM510494.pdf. Published June 6, 2016.
[iv] Weise M, Bielsky M-C, De Smet K, et al. Biosimilars: what clinicians should know. Blood. 2012;120(26):5111–5117
[v] Mulcahy AW, Hlávka JP, Case SR. Biosimilar cost savings in the United States: initial experience and future potential. Santa Monica, CA: Rand Corporation, 2017. https://www.rand.org/pubs/perspectives/PE264.html