Navigating the Biosimilar Frontier: Opportunities and Challenges in 2024

Jayne Hornung is the chief clinical officer at MMIT (Managed Markets Insight & Technology).

In the dynamic realm of health care, biosimilars have emerged as a subject of deep exploration, offering substantial promise for a new era of accessibility and affordability for patients and the broader health care industry. However, biosimilars are currently navigating a complex journey, complicated by an extensive approval process and remaining physician hesitance.

As we delve even further into this evolving landscape in 2024, an understanding from payers and providers is critical for these products to reach their full potential.

The Current Landscape of Biosimilars

Biosimilars are designed to replicate the therapeutic effects of original biologics, but they deviate from generics by being highly similar rather than identical to the reference drug. This type of drug recently has gained significant traction in the United State, with over 10 biosimilars receiving FDA approval in the US in the past 2 years alone. While slightly more than half of all FDA-approved biosimilars are cancer treatments, there is a growing number of approved and launched biosimilars for autoimmune diseases.

Biosimilars took center stage in pharma in 2023, with extensive conversations about how they could bring relief for patient spending and even become interchangeable with name-brand medications. However, the influx of these alternatives has prompted a reevaluation of their performance compared to brand names. CVS’ recent decision to drop Amjevita, an adalimumab (Humira) biosimilar, from its list highlights this complex and evolving relationship between the industry and these products.

This dual nature of biosimilars—offering cost-saving potential while posing distinctive challenges—will shape the future of these drugs. Biosimilars boast average sales prices over 50% lower than brand biologics at the time of launch—savings that are similar to traditional generics. Although this potential for cost savings exists, physicians have historically been hesitant to prescribe them due to the lack of knowledge on these products and their effects.

The Unique Benefits and Challenges of Biosimilars

The development and approval of biosimilars is inherently complex. While generic drugs are chemically identical to the innovator drug, containing the same active ingredients, a biosimilar is derived from living organisms and consists of larger, more complex molecules. Because of this, the FDA approval process for biosimilars is a bit more extensive than it is for generics. While generics are usually deemed interchangeable with the reference drug upon FDA approval, biosimilars must undergo an additional approval process for interchangeability. This demanding process makes the development more resource-intensive and time consuming, contributing to challenges such as a lack of immediate trust among health care professionals and patients.

Despite these challenges, there has been significant recent progress with FDA approvals and ongoing clinical trial testing—and this progress is increasing the acceptance of biosimilars among physicians. The growing popularity of biosimilars has prompted patient advocacy groups to rally behind bills that promote biosimilar prescribing, with the goal of decreasing patient spend. Physicians are increasingly acknowledging the benefits of prescribing biosimilars due to positive patient encounters, witnessing not only improved health outcomes but also significant cost savings for patients. For example, a close friend of mine who battled stage 4 breast cancer for 14 years saved thousands on out-of-pocket costs by switching to a trastuzumab (Herceptin) biosimilar.

Such personal anecdotes contribute to a broader narrative around cost, with biosimilars accounting for $9.4 billion in savings and a cumulative savings impact of $23.6 billion since their US entry in 2015. Beyond the financial stability they provide, biosimilars play a pivotal role in increasing patient access to critical medicines and expanding treatment options. With a wider array of treatments, more patients can find the care that suits their individual needs.

The State of Biosimilars in 2024

This year will hold significant promise and challenges for biosimilars. Numerous reference product contracts recently reached expiration, creating space for more generics and biosimilars to enter the market. This unfolding scenario is poised to reveal the true impact of biosimilars, fostering heightened competition that is anticipated to bring even more cost-reductions for patients.

However, within this optimistic outlook, there exists a constricted biosimilar landscape market, as seen through the withdrawal of several biosimilar manufacturers from the market. This trend hints at what may unfold in the coming years. Notably, larger well-known drug manufacturers, fortified by substantial budgets, are poised to take the reins, launching their own biosimilars and influencing the dynamics of the market.

As the US health care industry navigates this frontier, all stakeholders, from physicians to manufacturers, must understand the economic and competitive forces at play and the promise for optimizing patient outcomes. The physician, as a trusted professional, holds significant power here. By guiding patients through the benefits of biosimilars, and driving prescriptions, the promises of biosimilars can become realized in practice, marking a significant advancement in patient care and the broader healthcare industry.

The collaborative effort of pharmaceutical companies, regulatory bodies, and health care providers will play a pivotal role in shaping the trajectory of biosimilars in 2024. The ongoing refinement of regulatory frameworks and increased educational initiatives are essential components in building trust among health care professionals, paving the way for a more seamless integration of biosimilars into standard treatment protocols.