Humans have used biological products as medical treatments for centuries. In the early 20th century, increasing uses of biological products led to attempts to regulate their production, culminating in the Biologics Control Act of 1902. As work on genetics has advanced, so has the creation of biologics and biosimilars. Today, biosimilars are becoming more common — and changing the way specialty pharmacies consider and manage rare disease treatments.
The Entry of Biosimilars
For patients, comparing biosimilars to generic drugs and biologics to the generic’s name-brand counterpart may make sense. In practice, however, the creation of a biosimilar is more complex.
According to the U.S. Food and Drug Administration, a biosimilar is held to rigorous standards of purity, molecular similarity and bioactivity. It must be substantially similar to the biologic it mirrors in all these areas. Due to their complex biological nature, no biosimilars will be identical to their biologic counterparts — but the FDA requires the biosimilar to have “no clinically meaningful differences in safety, purity, or potency” compared to the reference biologic.
As of September 2023, the U.S. biosimilar market included 42 biosimilar approvals and 37 launches, write Brian Biehn and Connor Nell, directors at Cencora, formerly AmerisourceBergen. They include products classed for ophthalmology, oncology, and supportive care, as well as immunomodulators and insulin.
Additional members of these classes and biosimilars in other classes, including bone health and growth hormones, are currently in the development and approval pipeline. As of February 2023, 106 biosimilars were in development or seeking FDA approval, write Danielle Love and fellow authors at Cencora.
Biosimilars are under development at the same time the reference products they mirror are set to receive new levels of competition. Currently, 103 biologics are set to see their patents expire through 2025, says Aimee Tharaldson, senior clinical pharmacist of emerging therapeutics at Express Scripts. While not all expiring patented biologics have a biosimilar in development, Tharaldson estimates the opportunity created by these expirations may be worth $71 billion to the pharmaceutical industry.
The savings for patients may be extensive as well. “Biosimilars resulted in $21 billion in savings over the past 6 years,” notes Tharaldson.
Due to their relative complexity compared to many medications, biosimilars are more challenging — and more costly — to produce than standard generic drugs. As pharmaceutical companies rise to this challenge, biosimilars are entering the market, competing with their biologic counterparts and changing the landscape of specialty pharmacy.
Their Rising Adoption
While the U.S. federal government first addressed biologics in 1902, recent breakthroughs in biologic development have called for new approaches in legislation. In 2009, the Biologics Price Competition and Innovation (BPCI) Act created a shorter approval pathway for biosimilar and interchangeable treatments.
As more biosimilars become available, interest in their use — and their cost-saving capacity — increases as well. For instance, in July 2023, Express Scripts added three to its National Preferred Formulary alongside name-brand biologic Humira. By adding biosimilars to its formulary, Express Scripts seeks to make these medications more affordable.
“Since [Humira] was introduced, its list price increased by 470%,” says Adam Kautzner, president of Express Scripts, noting that this price increase occurred during a period in which Humira had little to no direct competition. Express Scripts hopes to use the competition introduced by biosimilars to drive down prices.
Interest is increasing not only in the presence of biosimilars but also in access to multiple biosimilar options for the same reference product. In a survey of 51 payers, 45 percent said they’d add two or three biosimilars to their preferred list if these products were available. By comparison, 35 percent said they’d choose one biosimilar, and only 4 percent wanted to cover solely the reference product, says Tasmina Hydery, associate director of digital solutions at Cencora.
These numbers have increased in recent years, notes Hydery. Five years ago, payers were more likely to prefer the reference product. Today, however, payers are interested in biosimilars — and they want multiple options.
Humira’s biosimilars offer an example of growing interest and adoption by payers. Several other factors also influence the expanding adoption of biosimilars for patient treatment, writes Bruce Feinberg, vice president of clinical affairs and chief medical officer at Cardinal Health. Factors Feinberg identifies include:
- The introduction of biosimilars in new treatment classes, such as ophthalmology.
- An expanding list of products achieving interchangeability.
- The launch of the Enhancing Oncology Model (EOM) and the reauthorization of BsUFA III, allowing the FDA to assess and collect fees for biosimilar products to expedite applications.
- Provisions in the Inflation Reduction Act that impact drug pricing.
Taken together, these factors are likely to drive the expansion of available biosimilars — and payer and patient interest in these products — for years to come.
What Specialty Pharmacies Can Expect
Price drives many decisions regarding biosimilar products, from which medications patients can afford to which medications appear on formularies. Yet cost isn’t the only consideration for biosimilar adoption.
For pharmacies, providers and other participants, the cost of a rare disease treatment must be balanced against factors like its efficacy. At Express Scripts, for instance, “our formulary decision process is guided by clinical effectiveness first and foremost, while also considering the needs and continuity of care for patients, in addition to competitive cost savings to our clients,” says Harold Carter, chief pharma trade relations officer.
Interchangeability also poses challenges for specialty pharmacies, providers and payers. Not every biosimilar approved by the FDA is automatically deemed “interchangeable” with the reference product. To receive an interchangeability status, a biosimilar must undergo additional testing to demonstrate that patients can switch between the reference product and the biosimilar safely.
Payers prize interchangeability, says Cate Lockhart, executive director of the Biologics and Biosimilars Collective Intelligence Consortium. Yet payers’ emphasis on interchangeability may create challenges for specialty pharmacists seeking to dispense biosimilar products for treatment. That a biosimilar has been deemed “interchangeable” with a reference product does not necessarily make that biosimilar a better choice than another biosimilar product, Lockhart notes.
For some biologics, interchangeability matters more than for others. One example is Humira (adalimumab), whose biosimilars “have several unique considerations, such as interchangeability and concentration, that will impact pharmacy practices and workflows,” write Stefanie Cisek and fellow authors in a 2023 article in the American Journal of Health-System Pharmacy.
Understanding the details involved in using adalimumab biosimilars will be essential for specialty pharmacists. Having this information will likely pay off as well. “Pharmacists are well positioned to educate providers and patients about this landscape and help implement an efficient workflow” to ensure patients receive adalimumab biosimilars effectively, write Cisek et al.
Specialty pharmacists are also well positioned to help payers understand what biologics like Humira and their associated biosimilars are used for — and which patients would benefit from biosimilar treatment, writes Angela Maas at PSG Consulting. Integrating quality data and coordination among all parties involved, including manufacturers and speciality pharmacies, can help patients benefit from access to these treatments.
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