The healthcare landscape is witnessing a transformative shift with the rise of biosimilars, which are poised to redefine affordability, access, and innovation in medical treatments. As these alternatives to well-known biologic drugs gain traction, they bring both opportunities and challenges that healthcare stakeholders must navigate.
What Are Biosimilars?
Let’s take a second to catch you up, or at least get on the same page. Biosimilars are not generic drugs but are highly similar to an already FDA-approved biologic, known as a reference product. Unlike generics, which are identical copies of chemical drugs, biosimilars are made from living cells and thus cannot be exact replicas. This introduces complexity in production but also an opportunity for cost savings and increased access to these specialized medications.
Impact on Healthcare Economics
The introduction of biosimilars in the market has led to significant economic implications. For example, the biosimilar Inflectra, competing against the well-established biologic Remicade, has offered a new lower-cost alternative for patients needing treatment for conditions like rheumatoid arthritis and Crohn’s disease. Despite the lower price, Inflectra has struggled to gain market share due to entrenched preferences for the original biologic from both doctors and patients (ZS Consulting).
The RAND Corporation estimates significant cost savings from biosimilars, projecting a potential reduction in biologic spending by $54 billion over a decade (ZS Consulting). These savings stem from the competitive pressures biosimilars introduce, driving down the prices of expensive biologic therapies.
Regulatory and Adoption Challenges
While the FDA has established a clear pathway for biosimilar approval, emphasizing rigorous standards for safety and efficacy, market adoption faces hurdles. One challenge is the “patent dance,” a litigation battleground where original manufacturers and biosimilar contenders engage over patent claims. This not only delays the entry of biosimilars but also stifles competition.
Another adoption challenge is the need for education among healthcare providers. A study published in the “Journal of Managed Care & Specialty Pharmacy” found that many physicians hold reservations about prescribing biosimilars due to uncertainties about their efficacy and interchangeability with reference products (Clarivate).
Strategic Moves by PBMs and Healthcare Providers
Pharmacy Benefit Managers (PBMs) are uniquely positioned to influence the uptake of biosimilars through formulary decisions and reimbursement policies. For instance, in response to the high cost of biologics, some PBMs have started to favor biosimilars in their formularies, encouraging physicians to prescribe them over more expensive originals (Managed Healthcare Executive). Furthermore, PBMs and health plans can provide both education as well as real world evidence showing experience with conversion to biosimilars.
Healthcare providers, for their part, can help bridge the knowledge gap by educating patients about the benefits and safety of biosimilars, thus fostering acceptance and trust. Innovative educational campaigns and provider incentives can be pivotal in this context.
The Future Landscape
In 2023, A Q1 report from IQVIA highlighted the slow uptake of Humira biosimilars, noting that the shift from Humira to its biosimilars has primarily been driven by smaller payers rather than the major three pharmacy benefit managers (PBMs). However, two of the big three PBMs, CVS and Express Scripts, are planning to take a more aggressive stance in supporting biosimilars of the Humira product. Both CVS and Express Scripts are set to prefer biosimilars that carry their own private labels, achieved through partnerships with pharmaceutical manufacturers, according to a recent Forbes article on the subject.
This strategy has faced criticism due to potential conflicts of interest. Despite this, there is a perspective that as experience with biosimilars grows, the market may see a more rapid and widespread transition from the brand-name Humira. Additionally, the pricing of Humira biosimilars co-branded by CVS or Express Scripts is approximately 85% lower than the original product, offering significant benefits to both patients and payers.
Ultimately, the key takeaway is that payers should be well-positioned to choose the Humira product with the lowest net cost, supported by comprehensive safety and efficacy data from real-world evidence.
Looking forward to the era of biosimilars, the success of these products is going to hinge on collaborative efforts across the healthcare system—regulatory clarity, real world evidence, dissemination of education, and strategic market actions. As more biosimilars enter the market, they promise not only to reduce healthcare costs, but also to enhance patient access to biological treatments that were previously unaffordable for many.
At Abarca, we are committed to leading the way in this new era of healthcare. We believe in a future where healthcare is seamless and personalized, leveraging smarter technology and innovative practices to serve our communities better. Every day, we work to make this vision a reality, starting with the critical area of prescription management but also extending beyond to foster a broader healthcare revolution.
References:
https://www.forbes.com/sites/joshuacohen/2024/05/02/cvs-caremarks-policy-shift-on-humira-biosimilars-may-not-be-what-the-doctor-ordered/
https://biosimilarscouncil.org/wp-content/uploads/2024/04/04022024_IQVIA-Humira-Tracking-Executive-Summary.pdf