The blockbuster drug Humira (adalimumab), developed by AbbVie, has been a top selling drug for over a decade, treating various autoimmune conditions. However, its patent expired in late 2022, paving the way for biosimilars to enter the market.
What are biosimilars?
A biosimilar is a biologic medical product that is highly similar to an existing approved branded biologic product, known as the reference product or originator biologic. Biosimilars and their reference products have no clinically meaningful differences in terms of safety, purity, or potency. Biosimilars offer more treatment options and have the potential to reduce healthcare costs, increasing access to lifesaving medicines.
Humira Biosimilar are produced through complex biotechnological processes and cannot be exactly identical to their reference product. However, extensive testing and clinical trials are required to ensure they are as safe and effective. Regulatory bodies like the FDA and EMA have strict guidelines in place to determine biosimilarity.
Major Humira biosimilars approved
Since Humira's patent expired in late 2022, many companies rushed to develop biosimilars. So far, the FDA has approved five Humira biosimilars:
1. Hadlima (Samsung Bioepis): Approved in April 2022.
2. Hyrimoz (Sandoz): Approved in November 2022.
3. Idacio (Pfizer): Approved in September 2022.
4. Hulio (Mylan): Approved in August 2022.
5. Yusimry (Coherus): Approved in January 2023.
The EMA and other regulators worldwide have also approved these five biosimilars. More are expected to enter these markets over the next few years.
Impact on market and costs
Analysts predict Humira biosimilars could capture over 60% of the US market by 2024. This will significantly impact AbbVie's revenues from Humira, which still dominates with over $20 billion in annual global sales currently.
The entry of multiple biosimilar competitors is also expected to substantially lower treatment costs. The FDA and payers have incentivized using affordable alternatives through substitution policies. It is estimated that the average list price of Humira could drop by 50-80% over the next three years.
This cost savings would directly benefit public and private healthcare payers in the US and other nations significantly. For example, Medicare is predicted to save $5 billion by 2026 just through increased Humira biosimilar utilization.
While AbbVie may attempt to retain market share through discounts and rebates of Humira, the lower prices of biosimilars will make them more attractive to providers, payers, and patients over the long term. Overall global Humira revenues were previously expected to peak at $25 billion by 2025, but that number is likely to decline faster now.
Commercial strategies
Companies with approved Humira biosimilars are employing different strategies to gain market share:
- Manufacturing capacity: Building large scale facilities to ensure stable supply.
- Pricing: Aggressively pricing biosimilars significantly below Humira's cost while still being profitable.
- Marketing: Educating providers, payers, and patients about immunogenicity risk and interchangeability.
- Logistics: Partnering with distributors for efficient fulfillment of orders across different healthcare settings.
- Rebates: Offering substantial rebates and discounts to pharmacies, hospitals and insurers to gain formulary placements.
- Indications: Some are seeking additional approvals beyond Humira's initially approved uses to broaden addressable patient pool.
- Portfolios: Developing biosimilars to other key biologics to become one stop solutions for customers.
Regulatory outlook
Going forward, global regulators are expected to continue streamlining approval pathways for interchangeable biosimilars through clarifying guidelines. They also aim to facilitate automatic substitution of biosimilars at the pharmacy counter to further increase market penetration.
At the same time, companies are investing in real-world evidence studies on switching and applying for interchangeable designations after original designation. If more Humira biosimilars gain interchangeable status, it could potentially accelerate uptake further.
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