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26/09/2023
A Recap: Wrapping Up the “Why Biosimilars” Series
From 2012, Samsung Bioepis has aimed to develop high-quality biosimilars in an efficient and rigorous manner. Today, we are proud to have an advanced portfolio of biosimilars in a wide range of therapeutic areas. As a global manufacturer of biosimilars, robust R&D expertise and the ability to carry out world-class pharmaceutical manufacturing processes is key for the company in finding smarter and faster ways to develop high-quality and affordable medicines. In fact, this is crucial for any biosimilar manufacturer as producing these complex medicines requires highly trained scientists who can perform sophisticated development processes that include numerous intricate tests.
To come up with an easier way to explain these processes, we created the “Why Biosimilars” series which seeks to explain the fundamentals of biosimilars all the way to how high quality is maintained throughout the processes and who they benefit the most. As a leading company in the industry, we feel that it is important to provide this type of information in easily accessible format and help health organizations and professionals have a better understanding of benefits and potential of biosimilars. We truly believe that educating people about biosimilars will lead to increased use of these valuable treatments and, consequently, make healthcare more accessible and affordable for many groups in society.
“Why Biosimilars” Series
The series starts off by describing biosimilars and how they are produced. While generic medicines are replicated to match the chemical structures of their reference products, biosimilars are based on the biological structures obtained from living cells. Next, state-of-the art analytical methods that are used to develop these medicines are introduced. Compared to small molecule generics, biosimilars cost more and take longer to develop than generic medicines. On average, it takes at least seven years and a hundred million dollars to develop one. Furthermore, biosimilars must go through much more comprehensive clinical studies compared to generic drugs.
The series also looks at differences that exist between biologic products and biosimilars. Both types of medicines rely on distinct tests that prove their safety and efficacy. While biologic or reference products need to verify comparability, biosimilars are required to prove biosimilarity. In addition, the assessments for biosimilarity are more extensive as they include clinical studies, non-clinical studies, and analytical studies.
The focus then turns to the three groups who are the main beneficiaries from the increased use of biosimilars: payers, physicians, and patients. In the United States, PBMs, or pharmacy benefit managers, are an additional factor in the equation, functioning as intermediaries between insurance providers and pharmaceutical manufacturers.
Lastly, the series explains what measures Samsung Bioepis goes through to maintain its quality assurance. By analyzing an extensive number of reference products, conducting advanced analytic methods, and implementing tight quality control, the company ensures that its biosimilars provide the same clinical benefits as reference products—but at a more affordable cost.
Raising Awareness for the Benefit of All
It is our hope that educational materials about biosimilars such as the “Why Biosimilars” series will introduce related stakeholders to essential information about these medicines and open up more avenues for people who are in need of accessible and affordable treatments for themselves and their loved ones. As long as there are unmet medical needs across the globe, Samsung Bioepis will continue striving to expand its expertise in more therapeutic fields. With #BiosimilarsUnpacked, we are confident that more people will receive the adequate treatments they deserve. That is our biggest reason for #DecodingBiosimilars.
i.Windisch J. Biosimilars versus originators: similarities and differences from development to approval. International Journal of Clinical Rheumatology. 2015;10:501-10
