Introduction to YUSIMRY
YUSIMRY, also known as adalimumab-aqvh, is a biosimilar to AbbVie’s blockbuster drug Humira, which has been a dominant player in the treatment of various autoimmune diseases. Here, we delve into the market dynamics and financial trajectory of YUSIMRY, a drug that is poised to make a significant impact in the biologics market.
Background on Humira and Biosimilars
Humira, developed by AbbVie, has been a cornerstone in the treatment of conditions such as rheumatoid arthritis, psoriatic arthritis, and Crohn’s disease. However, with the loss of exclusivity in early 2023, Humira faced competition from multiple adalimumab biosimilars, including YUSIMRY[4].
Market Entry and Competition
YUSIMRY was launched in July 2023 and quickly gained attention for being one of the most affordable adalimumab alternatives in the U.S. market. It is approved for nine indications, similar to Humira, and offers significant cost savings with discounts of up to 85% compared to Humira[2].
Despite the competitive pricing, YUSIMRY and other biosimilars face market resistance due to insurers’ contracting practices and the reluctance of some doctors and patients to switch from the established brand-name drug[1].
Ownership and Commercial Rights
In a significant move, Coherus BioSciences divested YUSIMRY to Hong Kong King-Friend Industrial (HKF) for $40 million. Following this deal, Meitheal Pharmaceuticals, HKF’s U.S. subsidiary, acquired the exclusive commercial rights to YUSIMRY in the U.S.[1].
Financial Performance and Projections
Coherus BioSciences reported net revenues of $142.0 million for the six months ended June 30, 2024, which included $35.9 million from the divested products, CIMERLI and YUSIMRY. The gain on the sale of YUSIMRY was $22.9 million, reflecting total cash proceeds of $40 million[3].
GlobalData forecasts that despite the declining sales of Humira, YUSIMRY is expected to achieve global sales of $436 million in 2025. This projection underscores the potential financial trajectory of YUSIMRY as it gains market traction[1].
Strategic Investments and Expansion
Meitheal Pharmaceuticals and its parent company, HKF, have made substantial investments to expand their biologics portfolio and capabilities. These investments include over $300 million in capital and R&D, and a $30 million investment in a monoclonal antibody drug substance facility. Such investments are crucial for ensuring sustainable product supply and supporting the commercialization of YUSIMRY[5].
Contracting and Partnering Strategies
Biosimilar manufacturers, including those behind YUSIMRY, are adopting novel contracting and partnering strategies to compete effectively. These strategies include signing exclusive contracts with payers to minimize net prices and secure preferred formulary positioning. This approach could potentially exclude Humira from some formularies, further boosting the market share of biosimilars like YUSIMRY[4].
Market Share and Dominance
Despite the entry of multiple biosimilars, Humira maintained a significant market share, with a 97% adalimumab volume share as of the end of 2023. However, this dominance is expected to wane as biosimilars gain more market footing. YUSIMRY, with its competitive pricing and strategic commercialization, is well-positioned to capture a substantial share of this market[4].
Challenges and Opportunities
One of the key challenges for YUSIMRY is overcoming the resistance from insurers and healthcare providers who may be hesitant to switch from the well-established Humira. However, the significant cost savings and the strategic investments by Meitheal and HKF are expected to drive adoption.
"With adalimumab biosimilars recently gaining traction, YUSIMRY is positioned to meet the ongoing demand for accessible treatment options due to key macro forces and the strategic investments being made in its production and commercialization," said Brian McCarthy, Meitheal Senior Vice President of Specialty[5].
Future Developments
Meitheal plans to develop pediatric presentations and a high concentration (100mg/mL) formulation of YUSIMRY, which will further expand its market reach. Additionally, the company’s acquisition of US rights to three insulin biosimilars from Tonghua Dongbao Pharmaceutical, with expected US approval in 2026, indicates a broader strategy to strengthen its biologics portfolio[1].
Key Takeaways
- Market Entry: YUSIMRY was launched as a biosimilar to Humira, offering significant cost savings.
- Ownership: Coherus BioSciences divested YUSIMRY to HKF, with Meitheal Pharmaceuticals gaining exclusive commercial rights in the U.S.
- Financial Projections: Forecasted global sales of $436 million in 2025.
- Strategic Investments: Substantial investments by Meitheal and HKF to support product supply and commercialization.
- Contracting Strategies: Adoption of novel contracting methods to secure market share.
- Market Share: Expected erosion of Humira’s dominance as biosimilars gain traction.
FAQs
What is YUSIMRY and how does it compare to Humira?
YUSIMRY is a biosimilar to AbbVie’s Humira, approved for nine indications similar to Humira. It offers significant cost savings with discounts of up to 85% compared to Humira.
Who owns the commercial rights to YUSIMRY in the U.S.?
Meitheal Pharmaceuticals, the U.S. subsidiary of Hong Kong King-Friend Industrial (HKF), owns the exclusive commercial rights to YUSIMRY in the U.S.
What are the forecasted sales for YUSIMRY in 2025?
GlobalData forecasts YUSIMRY to achieve global sales of $436 million in 2025.
What challenges does YUSIMRY face in the market?
YUSIMRY faces market resistance due to insurers’ contracting practices and the reluctance of some doctors and patients to switch from Humira.
What strategic investments have been made to support YUSIMRY?
Meitheal and its parent company, HKF, have invested over $300 million in capital and R&D, including a $30 million investment in a monoclonal antibody drug substance facility.
Sources
- Pharmaceutical Technology: "Coherus offloads Humira biosimilar Yusimry for $40m"
- BioSpace: "AbbVie's Humira Maintains Market Dominance Amid Biosimilar Launches Report"
- BioSpace: "Coherus BioSciences Reports Second Quarter 2024 Financial Results and Provides Business Update"
- Oliver Wyman: "Biosimilar Makers Carve New Path Via Contracting, Partnering"
- Business Wire: "Meitheal Pharmaceuticals Strengthens Biologics Portfolio with an Exclusive Commercial Licensing Agreement for YUSIMRY® a Biosimilar of Humira®"
Last updated: 2024-12-18
