Market Dynamics and Financial Trajectory for the Biologic Drug: Hadlima
Introduction to Hadlima and Adalimumab Biosimilars
Hadlima, developed by Samsung Bioepis, is a biosimilar of AbbVie's blockbuster biologic drug Humira (adalimumab). Humira, approved by the FDA in 2002, is a fully humanized monoclonal antibody used to treat various immune-mediated conditions such as rheumatoid arthritis, Crohn’s disease, and ulcerative colitis[1][3].
Market Share and Competition
As of May 2024, Humira's market share in the anti-inflammatory space has dropped to 82%, down from its previous dominance. This decline is largely attributed to the increasing presence of biosimilars. Hadlima, along with other biosimilars like Sandoz’s Hyrimoz and Coherus’ Yusimry, has been gaining ground. Hyrimoz, in particular, has seen significant growth, controlling around 13% of the market, while Hadlima and other biosimilars have also made notable inroads[1].
Pricing Strategies
While pricing has not been the primary factor in eroding Humira’s dominance, biosimilars like Hadlima and Yusimry offer substantial discounts. For instance, Hadlima and Yusimry are priced around 85% lower than Humira. However, the key drivers of market share shifts are more related to coverage and access rather than price alone[1].
Coverage and Access
The removal of Humira from major formularies by pharmacy benefit managers like CVS Caremark has significantly impacted its market share. For example, CVS Caremark’s decision to take Humira off its major formularies led to a surge in new prescriptions for Hyrimoz. Similarly, Hadlima has benefited from its inclusion in formularies by payers such as United Healthcare, Prime Therapeutics, and some managed Medicare organizations[1][4].
Patient Impact and Savings
Patients have seen substantial savings by switching from Humira to biosimilars like Hadlima. For instance, a patient named Jennifer, who switched from Humira to Hadlima, reduced her monthly co-insurance payment from $1,730 to $259, saving $1,471 per month[2].
Financial Performance of Hadlima
Hadlima has shown promising financial growth. In 2023, Hadlima generated $44 million in total worldwide revenue, up from $19 million in 2022. This growth indicates increasing adoption and acceptance of the biosimilar. Additionally, Hadlima has led all biosimilars in total prescriptions for several weeks, further solidifying its market position[4].
Market Growth and Projections
The adalimumab biosimilar market, which includes Hadlima, is projected to grow significantly. The market size is expected to reach approximately $6,044.9 million by 2033, growing at a CAGR of 23.4% from 2024 to 2033. This growth is driven by factors such as increasing chronic diseases, patent expirations, cost-efficient healthcare, and supportive regulatory environments[3].
Distribution and Access Channels
Hospital pharmacies and retail pharmacies play crucial roles in the distribution of adalimumab biosimilars. Hospital pharmacies dominated with over 32.1% of the market share in 2023, offering convenient access within healthcare ecosystems. Retail pharmacies also exhibited steady growth, serving as accessible sources for these medications[3].
Challenges and Opportunities
Despite the growth, the biosimilar market faces challenges such as complex manufacturing processes, stringent regulatory requirements, and limited patient understanding. However, opportunities for expansion in emerging markets, strategic collaborations, technological advancements, and diversified therapeutic indications present significant growth potential[3].
Co-Promotion Strategies
The partnership between Sandoz and Cordavis, a subsidiary of CVS Health, has created an alternative path for biosimilars to offer value and disrupt traditional incentives favoring innovators. This co-promotion strategy has helped Hyrimoz gain significant market share, and similar strategies could benefit Hadlima and other biosimilars[5].
Regulatory Environment
The FDA’s approval of biosimilars with interchangeability designations, such as Hadlima and Simlandi, has facilitated their integration into the market. This regulatory support is crucial for the continued growth of the biosimilar sector[1][3].
Patient Support Programs
Hadlima, like other biosimilars, offers patient support programs such as dedicated nurse coaches, educational resources, and co-pay savings cards. These programs help patients navigate the treatment process and reduce financial burdens, enhancing patient adherence and satisfaction[2].
Key Takeaways
- Market Share: Hadlima and other biosimilars are gaining market share from Humira, driven by coverage and access rather than pricing.
- Financial Growth: Hadlima has shown significant revenue growth and is expected to continue this trend as the adalimumab biosimilar market expands.
- Patient Savings: Patients switching to Hadlima can achieve substantial savings, improving affordability and treatment adherence.
- Distribution: Hospital and retail pharmacies are key channels for the distribution of adalimumab biosimilars.
- Challenges and Opportunities: The market faces challenges but also presents opportunities for growth through strategic collaborations and technological advancements.
FAQs
What is Hadlima and how does it compare to Humira?
Hadlima is a biosimilar of AbbVie's Humira (adalimumab), offering a highly similar biological agent at a lower cost. It is used to treat the same immune-mediated conditions as Humira.
How has the market share of Humira been affected by biosimilars?
Humira's market share has dropped to 82% as biosimilars like Hadlima and Hyrimoz gain ground, primarily due to changes in coverage and access.
What are the key drivers of the shift towards biosimilars?
The key drivers include coverage and access changes by pharmacy benefit managers and the inclusion of biosimilars in formularies by major payers.
How much can patients save by switching from Humira to Hadlima?
Patients can save significantly, with one example showing a monthly savings of $1,471 by switching from Humira to Hadlima.
What is the projected growth of the adalimumab biosimilar market?
The market is projected to grow at a CAGR of 23.4% from 2024 to 2033, reaching approximately $6,044.9 million by 2033.
Sources
- AbbVie's Humira Continues to Lose Market Share as Biosimilars Gain Ground Report. Biospace.
- HADLIMA™ For You - Dedicated Patient Support & Savings. Hadlima.
- Adalimumab Biosimilar Market Size, Trends | CAGR Of 23.4%. Market.us.
- The VA Replaces Humira with Hadlima on National Formulary. Managed Healthcare Executive.
- Biosimilar and Innovator Co-Promotions: The Changing Tide. IQVIA.
