How can the US healthcare system learn from the European Union on market penetration for biosimilar products?
A popular misbelief prevails in the United States that our healthcare system is the best and most efficient in the world. The facts, however, state otherwise. According to multiple reports, including a 2013 Institute of Medicine report, the US healthcare system ranks at the bottom of most developed economies while simultaneously being the most expensive.1 The primary reason for this discord in efficiency is a lack of competition in the healthcare markets coupled with a lack of agility.
Over the last 30 years, the biologics class of drugs (monoclonal antibodies, cellular growth factors, erythropoiesis stimulating factors, and granulocyte colony stimulating factors) represents one of the fastest growing sectors of the drug industry world-wide.2 These drugs have applications both in supportive care as well as therapies for chronic autoimmune disorders and cancer care. The development of newer checkpoint inhibitors and immunotherapy has expanded the scope, application, and indications of biologics across a wide spectrum of disorders. However, the ever-escalating cost of care threatens access to life saving medications and posts a threat of financial toxicity for both individuals and the healthcare system.3
Global Perspective
The class of biosimilar medicines has emerged as a potential solution across the globe, providing an answer to the ever-expanding expenses of biologics. A vast majority of developed economies as well as developing countries have figured out systemic processes for incorporating biosimilars in their regulatory workflow, leading to the successful entry of biosimilars in their healthcare market. The United States, however, lags by almost a decade in exploring this highly feasible solution to the rising cost of care.
The European Medicines Agency led the process of guideline development for biosimilars in 2005,4 which addressed quality, safety, and efficacy. Subsequent revision of these guidelines in 2013 included nonclinical, clinical, and quality issues as well as product-specific guidance. Although the US Biologics Price Competition and Innovation Act of 2009 was passed and went into effect in 2010, FDA approval of the first US biosimilar product, filgrastim (Zarxio) from Sandoz, came almost 5 years later and was almost a decade behind the first biosimilar drug approval in Europe. Subsequently, the US FDA approved biosimilars for infliximab (Inflectra) by Pfizer in 2016. Approval of the first biosimilar bevacizumab, a monoclonal antibody, in the true cancer therapeutic class is expected later this week.
US Challenges
Despite the promises that this class of drugs presents, both from a cost perspective as well as access, their market penetration does not seem to be likely very soon. Let us consider the challenges associated with a successful launch of biosimilars in the United States.
Regulation
Unlike the European Union, the US biosimilar market is influenced by regulatory agencies such as the FDA, payers (CMS, HHS-state Medicaid and managed care organizations, Medicare advantage plans, and commercial plans), wholesalers and group purchase organizations, and consumer advocacy groups amongst many other factors. The US healthcare market is significantly different from a majority of European markets. National coverage determination (NCD) policy would be the first hurdle that a new entrant would face. NCD would be followed by implementation by all regional Medicare contractors to prepare their own local coverage determination. These policies would only apply to Medicare beneficiaries. Each state HHS (Medicaid administration) would then need to modify their policies.
Pricing
Subsequent challenges would be to create the fee schedule. Biosimilar products need to be priced at a level where providers would be encouraged to consider incorporating biosimilars in their offerings. According to a survey conducted by the National Comprehensive Cancer Network in 2011, only about 20% of providers would be early adopters of biosimilar products.5 The lack of awareness and education in the provider world could present formidable challenges that could limit the success of biosimilars in the US markets.
Education
The next challenge would be to educate different stakeholders, including patients and patient advocacy groups, to raise awareness through educational programs. Additionally, payers would need to consider tiering biosimilars as well as managing out-of-pocket costs in a way that would ensure that biosimilar adoption remains an attractive proposition. Lastly, patient assistance programs and indigent patient programs would need to be at par with reference products.
To summarize, several challenges could prevent biosimilar entry into an already tightly-held market, prompting strategic thinking, careful planning, and clear implementation policies. While biosimilars do promise a solution for addressing Part B drug prices in the United States, biosimilar manufacturers would require substantive planning to avoid lost opportunity.
References
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
The 6 Key Policy Factors to Ensure Biosimilar Market Sustainability
April 16th 2024Magnus Bodin, senior director and head of international access and policy at Biogen, presented warning signs for unsustainable biosimilar markets as well as key factors needed to create effective policies and future-proof biosimilar markets globally.