How can we achieve a long-term sustainable biosimilars market?

Pfizer Global Biosimilars Commercial Lead, Roman Irsiegler, gives his thoughts on why a sustainable biosimilars market is critical for the healthcare industry, and what stakeholders can do to achieve it.

As part of a group of medicines known as biologics, biosimilarshavethe potential to revolutionize the treatment of many medical conditions, including some cancers.¹Biosimilar medicines have no clinically meaningful difference from existing licensed biological medicines (called reference products), and are highly similar in terms of quality, efficacy, and safety²

A key benefit of biosimilars is that they can be between 20–40% cheaper than the reference product,³ thereby increasing accessibility for patients. This allows for treatment at reduced costs,⁴ and enables reinvestment into patient care, services, and innovation.⁵ Global cumulative savings from biosimilars alone are projected to reach $215 billionby 2026.⁶ With spending on global medicines set to reach $1.9 trillion by 2027^,7 biosimilars are vital to support more sustainable healthcare systems and enable continued access to treatment for patients.

Multiple stakeholders are responsible for ensuring the long-term sustainability of the biosimilars market. Collaboration to align incentives between physicians, manufacturers, payers, pharmaceutical companies, and policymakers, is imperative for establishing a framework that benefits all and leads to long-term viability.

Reimbursement policies in the USA are critical hurdles in biosimilar sustainability. This has created a market dynamic in which there may be a financial burden on some providers trying to offer patients with low-cost treatment options.⁸ All stakeholders need to be aligned on incentives that promote biosimilar sustainability and uptake, and that achieve cost savings, while supporting healthy competition that takes into account patient and provider treatment choices.

Another key hurdle in achieving a long-term, sustainable biosimilars market is procurement practice that only considers savings in the short term, and does not consider the other elements of value, including quality, robustness of supply chains, reliability of supply, and product stability. The industry needs to move away from these single-winner, price-only bidding processes, which not only limit physicians’ choices but, crucially, lead to rapid price erosion and a reduced number of competitors, as manufacturers compete to undercut prices.^4,9–11 This has a knock-on effect on drug supply, resulting in shortages that impact all stakeholders, particularly patients whose care and treatment may be impaired.¹²

In western China, shortages of antimicrobials, biologics, and anticancer drugs are attributed to several factors, but the most common cause reported is that treatments are priced too low. Compulsory price-reduction policies and competitive public bidding mean that only manufacturers who provide the lowest price win the bid. Manufacturers are therefore disincentivized, leading to shortages.¹²

The supply shortages of breast cancer cornerstone medicine, tamoxifen, in Germany has raised concerns for patients and highlighted the challenges faced by off-patent medicines manufacturers operating in markets driven by cost-containment policies, forcing medicine prices into a dangerous downwards spiral. With the market becoming unattractive to manufacturers, investments in a resilient supply chain are disincentivized, and with reduced suppliers in the market, if one has an issue, the others may struggle to cover the supply gap.¹³

The biosimilars market needs an environment that fosters healthy competition, ensures continuity of supply, and encompasses the quality and reliability of manufacturers into value-based criteria. Healthy competition enables predictable pricing, which allows manufacturers to make long-term decisions required to invest in biosimilar development and enables a sustainable high-quality supply chain of a product. Multi-winner bidding processes have the potential to do this while providing cost savings that result in sustainable long-term price dynamics and a fair opportunity for all market players to generate and maintain sufficient product supply.¹⁴

Crucially, long-term biosimilar sustainability can only be achieved through the collaboration of all stakeholders. By applying this approach, many can benefit from a competitive yet sustainable market, ensuring continued patient access to cornerstone biologic medicines.

With over 30 years of experience in biologics and one of the broadest biosimilar portfolios globally, Pfizer is committed to expanding patient access to treatments and generating financial solutions for healthcare system reinvestments into patient care and services.

PP-UNP-GLB-1585. Date of preparation: September 2023

References

1. Pfizer. What are biosimilar medicines? https://pfizer.com/news/articles/what_are_biosimilar_medicines (accessed June 2023).
2. FDA. Biosimilar development, review, and approval. https://fda.gov/drugs/biosimilars/biosimilar-development-review-and-approval (accessed June 2023).
3. Pharmaceutical Technology. Biosimilar development: The incentives and challenges. https://pharmaceutical-technology.com/comment/commentwhat-are-the-incentives-and-challenges-to-biosimilar-development-5751024/ (accessed June 2023).
4. IQVIA. Spotlight on biosimilars 2021. https://iqvia.com/insights/the-iqvia-institute/reports/spotlight-on-biosimilars (accessed June 2023).
5. Vulto AG et al. Sustainability of Biosimilars in Europe: A Delphi Panel Consensus with Systematic Literature Review.Pharmaceuticals 2020;13:400.
6. IQVIA. The Global Use of Medicines 2022: Outlook to 2026. https://iqvia.com/insights/the-iqvia-institute/reports/the-global-use-of-medicines-2022 (accessed June 2023).
7. IQVIA. Global Use of Medicines 2023: Outlook to 2027. https://www.iqvia.com/insights/the-iqvia-institute/reports/the-global-use-of-medicines-2023 (accessed June 2023).
8. AJMC. What's Holding Up Biosimilar Uptake? Misconceptions, Misaligned Incentives, Panelists Say. https://www.centerforbiosimilars.com/view/what-s-holding-up-biosimilar-uptake-misconceptions-misaligned-incentives-panelists-say (accessed June 2023).
9. Barbier L et al. Off-Patent Biologicals and Biosimilars Tendering in Europe—A Proposal towards More Sustainable Practices. Pharmaceuticals 2021;14:499.
10. Biosimilar development. The second wave of biosimilars: new scenarios, new rules.https://biosimilardevelopment.com/doc/the-second-wave-of-biosimilars-new-scenarios-new-rules-0001 (accessed June 2023).
11. Organon. Biosimilars: a global roadmap for policy sustainability.https://biosimilarsroadmap.com/wp-content/uploads/sites/19/2022/07/Biosimilars-A-global-roadmap-for-policy-sustainability-Final.pdf (accessed June 2023).
12. Yang C et al. Current Situation, Determinants, and Solutions to Drug Shortages in Shaanxi Province, China: A Qualitative Study. PLoS One 2016;11:e0165183.
13. Medicines for Europe. Supply crunch for essential cancer medicines shows the urgent need to revise unsustainable pricing and tendering policies. https://www.medicinesforeurope.com/news/supply-crunch-for-essential-cancer-medicines-shows-the-urgent-need-to-revise-unsustainable-pricing-and-tendering-policies/ (Accessed June 2023).
14. GaBI. Policy recommendations for a sustainable biosimilars market: lessons from Europe.https://gabi-journal.net/policy-recommendations-for-a-sustainable-biosimilars-market-lessons-from-europe.html (accessed June 2023).