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20/11/2019 Why we should embrace biosimilar competition

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Dr. Sang-Jin PakSenior Vice President and Head of
Commercial Division
Samsung Bioepis

It has been widely acknowledged that uptake of biosimilars in the United States (US) has been less than optimal. However, we need to exercise a certain level of patience and caution, when it comes to talking about the future of the US biosimilar market. It may be unfair to compare a rapidly maturing European biosimilar market with a US market that has just started to see biosimilars. Yet the tide appears to be turning in the favor of biosimilars in the US. In fact, some biosimilars are already beginning to surpass sales of their reference medicine in the US1 , while legislations supporting positive incentives for patients when a biosimilar is prescribed, are currently moving through the Congress.2 3

Earlier this month, I joined other industry leaders to debate the topic of biosimilar competition at the GRx+Biosims 2019, an annual conference for generic and biosimilar medicines hosted by Association for Accessible Medicines (AAM). I’m a strong believer in the potential of biosimilars to deliver on the growing need for more sustainable healthcare across the world. In fact, it has been suggested that from 2014 to 2024, the US healthcare system could save USD 250 billion if biosimilars were more widely adopted.4 We have already seen in Europe that the increased competition from biosimilars entering the market has not simply reduced the reference medicine price, but the price of the product class as a whole.5

Yet it is not only the potential cost savings that biosimilar competition offers, but the opportunity to drive innovation in the marketplace, so that ultimately patients can access a broader pool of therapies at more affordable prices. For instance, with the launch of filgrastim biosimilar in the United Kingdom (UK), more patients were able to be treated at an earlier stage - including those who may not have had access previously.6

In order to create and sustain this positive ecosystem, incentivizing biosimilars and generics is a must. Incentivizing the use of biosimilars will undoubtedly support the next wave of treatments across neuroscience, oncology, cell and gene therapy. Competition and innovation will help the market to grow in a healthy way, which in turn will make biologic therapy more affordable and accessible.

A healthy and thriving biologic and biosimilar market will also help to establish an important circle of sustainability within the healthcare system. By simultaneously sparking innovation, growing the market and lowering costs, we ensure more patients have access to treatments earlier on, and in the longer-term. As we know from clinical research, this is especially important for patients with conditions like rheumatoid arthritis (RA) or inflammatory bowel disease (IBD), who can have long-term complications if not treated at the early stage of disease development.7 8

Based on the lively discussions at the conference, I remain hopeful that US regulators, policymakers, clinicians and insurers will continue to work closely with the biosimilars industry to encourage wider adoption of biosimilars that will ultimately benefit patients and support the sustainability of the system. In the meantime, it is important to recognize that market shaping takes time, particularly in a complex environment like the US, and with patience we can see that significant progress is already being made.


1 Zarxio Practical Information Brochure. Available at: https://www.zarxio.com/globalassets/zarxio9/assets/practical-information-for-zarxio-brochure.pdf . Last accessed October 2019.
2 The Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars (ACCESS) Act https://scottpeters.house.gov/media-center/press-releases/reps-peters-king-brindisi-introduce-bipartisan-bill-to-make-cost-0 Last accessed October 2019.
3 Bolstering Innovative Options to Save Immediately on Medicines (BIOSIM) Act. https://schrader.house.gov/newsroom/documentsingle.aspx?DocumentID=392607
4. Express Scripts. The $250 Billion Potential of Biosimilars. https://www.ftc.gov/system/files/documents/public_events/Follow-On%20Biologics%20Workshop%3A%20Impact%20of%20Recent%20Legislative%20and%20Regulatory%20Naming%20Proposals%20on%20Competition/miller.pdf Last accessed November 2019.
5. IQVIA. 2018. The Impact of Biosimilar Competition in Europe. Last accessed October 2019.
6. IMS Institute for Healthcare Informatics. Delivering on the Potential of Biosimilar Medicines: The Role of Functioning Competitive Markets. 2016 March. Available at: https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/delivering-on-the-potential-of-biosimilar-medicines.pdf?la=en&hash=03018A6A86DED8F901DDF305BAA536FF0E86F9B4&_=1534765504516. Last accessed October 2019
7. Finckh, Axel, et al. "Treatment of very early rheumatoid arthritis with symptomatic therapy, disease-modifying antirheumatic drugs, or biologic agents: a cost-effectiveness analysis." Annals of Internal Medicine 151.9 (2009): 612-621.
8. Im, Jong Pil, et al. "Changing treatment paradigms for the management of inflammatory bowel disease." The Korean journal of internal medicine 33.1 (2018): 28.