Dr Karara provides insight into how unbranded biologics are impacting the overall treatment landscape.
Kareem Karara, PharmD, BCPS, CCHP: The regulatory requirements of an unbranded biologic are quite simple. Because unbranded biologics are marketed under the branded biologic’s original BLA [biologics license application], there are no additional regulatory requirements. This is different from a biosimilar, which must demonstrate FDA-defined parameters of clinical similarity.
Biologic medications fit into the treatment landscape for autoimmune diseases in the following ways: They’re prescribed to treat autoimmune diseases, including many types of arthritis, rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis. Biologics work by disrupting the inflammatory process in a lot of these conditions that can lead to things like joint pain and destruction. For example, in rheumatoid arthritis, biologics have added a lot of treatment options to our toolkit and DMARDs [disease-modifying antirheumatic drugs]. They’ve greatly improved treatment outcomes for people with rheumatoid arthritis by blocking activity of key proteins involved in inflammation. Biologics target specific parts of the immune system, such as tumor necrosis factor and interleukin.
The number of unbranded biologics in this space is limited at this time, but some are available for treatment. For example, unbranded infliximab [Remicade] is available. Infliximab is one of the most well-studied biologics for the treatment of autoimmune diseases due to how long the reference product has been available. Remicade was first approved in 1998. The availability of unbranded biologics in the autoimmune space has the potential to increase the adoption of biologics in the treatment of these conditions by improving patient access and cost savings.
Transcript edited for clarity.