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Understanding Biosimilar Basics

Biosimilars syringe bottle and syringe

With Humira® biosimilars expected to have a significant impact in 2024, some ClearScript clients are asking for more information. Here we provide the biosimilar basics and what their increasing presence in the marketplace means to the pharmacy benefit.

What are biosimilars

  • Definition: Biosimilars are products that are “highly similar” to already FDA-approved biologic medications, which are known as reference products. These reference products are typically large, complex molecules derived through biotechnology.
  • Approval Pathway: The Biologics Price Competition and Innovation Act (BPCIA) of 2009 paved the way for biosimilars by creating an approval pathway. Unlike traditional chemical drugs, biosimilars are not identical copies but very closely resemble their reference products.
  • Efficacy and Safety: To gain FDA approval, biosimilars must demonstrate equivalent treatment benefits and have no meaningful differences in their clinical function and safety profile compared to the reference biologic product.

Biosimilars vs. Traditional “Small Molecule” Generic Drugs

Some people assume biosimilars are “generics”, but that is not the case.

  • Not Exact Copies: Biosimilars are not 100% identical molecules to the reference brand. However, from a clinical standpoint there is no meaningful difference in how they function or their safety profile. In the market, they are best understood as competing brands offering the same therapeutic benefits.
  • Interchangeability: Some biosimilars meet additional FDA requirements to be classified as interchangeable products. This means they can be substituted without prescriber consultation where permitted by law. Although non-interchangeable biosimilars require a new prescription, this does not imply clinical inferiority compared to interchangeable products. The ability to substitute at the pharmacy greatly simplifies switching between products.

Benefits for Pharmacy Benefit Plans and their Members

Biosimilars offer a promising avenue for more cost-effective therapies while maintaining safety and efficacy. As the landscape evolves, understanding biosimilar basics becomes crucial for informed decision-making.

  • Price Competition: By introducing biosimilars, the marketplace experiences increased competition. Unlike generic drugs, which can rapidly generate price reductions due to simpler manufacturing processes, biosimilar competition takes longer to build momentum (usually measured in years rather than months).
  • Potential for Cost Reduction: As the FDA approves additional biosimilar and interchangeable products, heightened competition for favorable formulary status can create substantial cost-saving opportunities for pharmacy benefit plans. This contrasts to previous market dynamics when a single manufacturer monopolized a specific biologic and little to no competition often led to higher prices.

ClearScript’s Biosimilar Formulary Strategy

ClearScript takes a comprehensive approach to managing biosimilar medications, starting with formulary placement. Some key formulary strategy components include:

  • Evaluation Process: The Pharmacy & Therapeutics Committee comprising physicians and pharmacists evaluates every biosimilar medication approved by the FDA. The evaluation considers clinical efficacy and safety data for placement on the ClearScript formulary.
  • Preferred Tiers: Reference products and biosimilars meeting clinical and safety thresholds are strategically placed on preferred tiers within the formulary based on their ability to drive value via lower net cost in their therapy class. Preferred tiers may contain the reference brand, biosimilars, or mixes of both.
  • Utilization Management: ClearScript recommends utilization management strategies based on clinical guidelines and medical research. Once clinical requirements are satisfied, there may be sequential steps to prioritize products which deliver the highest value first.

The impact of Humira® Biosimilars

  • Humira® Significance: Humira® is a top-selling pharmaceutical globally. It is a major contributor to plan sponsors’ costs due to its high expense and relatively significant utilization as a specialty drug. From 2011 to 2021, worldwide net revenues more than doubled from $7.9 billion to $20.7 billion.
  • Biosimilar Launch: The launch of Amjevita™, the first biosimilar for the drug Humira® in early 2023, was of a less utilized strength and non-interchangeable. Other biosimilars that launched in 2023 were the ‘low-concentration’ as well and uptake to date has been minimal.
  • Uptake of Humira® Biosimilars: Starting in 2024, there will be ‘high-concentration’, interchangeable biosimilar options. As these more popular formulations launch, increased competitive pressure will build momentum over time and result in greater savings.

ClearScript’s Humira® Biosimilar Strategy in 2024 and Beyond

ClearScript remains committed to enhancing options and savings opportunities for its members and plan sponsors.

  • Co-Preferred Status: Currently, Humira® and the biosimilars Amjevita™, Cyltezo®, Hyrimoz®, and Adalimumab-ADAZ (a low-cost option for HDHP) are all co-preferred on the ClearScript Formulary with utilization management strategies in place to provide the highest value. Cyltezo® is the only formulary biosimilar currently with an interchangeable status.
  • Looking ahead: The anticipated debut of more utilized, high-concentration formulations for both Amjevita™ and Cyltezo® should result in more pressure on Humira®’s market share. Other manufacturers are also pursuing interchangeable, high-concentration offerings. As the biosimilar landscape evolves, ClearScript continues to adapt its strategies to benefit both patients and plan sponsors.

Biosimilar Outlook – Products of Note

Reference DrugIndication(s)Outlook
Actemra® SCRheumatoid arthritisThree biosimilars, 2024-2025 launch
Cimzia®Crohn’s, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasisLoses exclusivity in 2024. Biosimilars in development, possible 2027 launch.
Cosentyx®Hidradenitis suppurativa, plaque psoriasis, psoriatic arthritis, ankylosing spondylitisBiosimilar in Phase 3 trials.  Launch possibly 2029-2030.
Enbrel®Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasisTwo biosimilars approved, release in 2029
Simponi®Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitisLoses exclusivity in 2024. Biosimilars in development, approvals maybe late 2024, but likely 2025
Xolair®Moderate to severe asthma, multiple food allergyFour biosimilars in development.  Possibly late 2024 for 1st launch.

ClearScript continues to closely monitor developments in the biosimilar landscape for Humira® biosimilars and others. We continually evaluate and refine our management strategy to ensure members have access to effective therapy options that improve health and lower costs. As more biosimilar products become available, product preference and formulary status may change to provide the best management strategies for our clients and more choice for the members we serve.