Understanding Unbranded Biologics

Immune-mediated diseases such as psoriasis, psoriatic arthritis, rheumatoid arthritis, Crohn’s disease, and other conditions impact millions of people in the United States. To help reduce the health burden of these chronic diseases, industry players are exploring ways to translate immune pathway insights into innovative biologic treatments that help patients navigate their treatment journey.

Within the immunology biologics market, new reference products are frequently followed by successful biosimilar launches that drive healthcare costs down. In a session sponsored by Janssen Biotech, Inc., at the Payer Issues Roundtable hosted by Becker's Hospital Review, leaders from Janssen discussed biologics in the immunology category and the potential benefits of unbranded biologics to patients and payers. The session was led by Nancy Paliotta, Senior Director, Lifecycle Strategy, Immunology, Janssen Biotech, Inc.

A key focus of the session was providing educational background on unbranded biologics – a category of biologic products that are offered at a lower list price compared to their brand-name biologic counterparts. Unlike biosimilars, unbranded biologics are produced using the same cell line as the brand-name biologic. They have the same strength, dosage form, route of administration, and presentation as the brand-name biologic, and they are considered by the FDA to be the same product as the brand-name biologic under the same biologics license. Janssen has consistently supported the regulatory and reimbursement pathways for all biologic products by supporting policy changes to ensure comparable treatment. In addition, patient safety and therapeutic choice remain paramount through rigorous FDA standards.

This unbranded biologic treatment option comes as there is significant growth anticipated in the immunology biologics market. By 2023, for example, the number of biologics, including biosimilars, approved to treat immune-mediated diseases is expected to more than double.

Beyond diving deeper into unbranded biologics as an emerging category, session attendees discussed what these products might offer to payers and healthcare providers as a new treatment choice for patients. Unbranded biologics can lower costs for patients whose out-of-pocket cost is tied to list price since an unbranded biologic generally has a lower list price compared to its reference brand-name biologic.

Recognizing the challenges that many patients impacted by immune-mediated diseases can face throughout their treatment journey, unbranded biologics offer another therapeutic option that can support continuity of care and potentially allow patients to remain on their preferred treatment.  Paliotta also noted that government payers can benefit from discounts provided on both branded biologics as well as discounts provided for unbranded biologic products.

Throughout the roundtable, attendees asked a number of questions regarding the unbranded biologic product category. As a recently introduced class of products, many payer attendees had little prior knowledge or awareness about unbranded biologics and their potential impact for patients and providers. Following the event, audience members left with a better understanding of unbranded biologics and the driving reasons behind the introduction of these products to the market.

“Our principal objective of the discussion was to educate and inform attendees on these products and their role within the broader immunology treatment landscape,” concluded Paliotta. “We are eager to continue educating payers, providers, patients, and other healthcare stakeholders on unbranded biologic offerings as this market space continues to evolve.”

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