HUMIRA BIOSIMILAR MARKET ANALYSIS

Market Challenges And Opportunities

Global Humira Biosimilar Market Drivers:

• Patent expiration: The expiration of the patents protecting humira paved the way for the entry of biosimilars. Once the patents expire, it allows other pharmaceutical companies to develop and market biosimilar versions of humira, creating competition in the market.
• Cost savings: Biosimilars offer a more cost-effective alternative to the reference biologic drug. With the increasing demand for affordable healthcare, biosimilars provide an opportunity to reduce treatment costs for patients, healthcare systems, and payers. This cost-saving potential is a significant driver for the adoption of humira biosimilars. For instance, on October 26, 2023, Celltrion USA, Inc., a biopharmaceutical company, announced its FDA-approved biosimilar, YUFLYMA (adalimumab-aaty), has been added to CarePartners Specialty Pharmacy Cost Savings Programs. YUFLYMA is a high-concentration (100mg/mL) and citrate-free formulation of the Humira (adalimumab) biosimilar. CarePartners and its strategic partners will offer and distribute YUFLYMA as the lowest net cost high-concentration Humira (adalimumab) biosimilar to over 10 million plan members.
• Increasing prevalence of autoimmune diseases: Autoimmune diseases, such as rheumatoid arthritis, psoriasis, and crohn's disease, are on the rise globally. The growing prevalence of these conditions drives the demand for effective and accessible treatments, including biosimilars of humira, which are proven therapies for autoimmune diseases.
• Favorable regulatory environment: Regulatory agencies in various regions had established guidelines and pathways for the approval and market access of biosimilars. These frameworks provide clarity and facilitate the development, evaluation, and commercialization of humira biosimilars. Favorable regulatory environments encourage pharmaceutical companies to invest in the development of biosimilars.

Global Humira Biosimilar Market Opportunities:

• Increased access to treatment: The availability of humira biosimilars offers an opportunity to improve access to treatment for patients with autoimmune diseases. Biosimilars provide a more affordable alternative to the reference biologic drug, allowing a broader population to benefit from effective therapies.
• Market expansion and competitiveness: The introduction of humira biosimilars creates competition in the market, thereby driving innovation and cost optimization. This competition encourages pharmaceutical companies to develop and launch biosimilars, thus leading to a more competitive landscape. It also promotes market growth and the development of a diverse range of treatment options for patients.
• Enhanced treatment choices: The availability of humira biosimilars expands the range of treatment choices for physicians and patients. Physicians can select from multiple biosimilar options based on factors such as patient needs, pricing, and clinical evidence. Patients can benefit from a wider selection of therapies which are tailored for their specific conditions and preferences.
• Global market expansion: The humira biosimilar market presents opportunities for global expansion. As regulatory pathways and guidelines for biosimilars continue to evolve and improve worldwide, pharmaceutical companies can seek approvals in various regions, thus tapping into new markets and reaching a larger patient population.