Patients Weigh In on Biosimilars

Bret S. Stetka, MD

Disclosures

February 22, 2016

Editor's Note: On February 9, 2016, the US Food and Drug Administration (FDA) Arthritis Advisory Committee recommended the approval of CT-P13, a biosimilar to Janssen Biotech Inc.'s Remicade® (infliximab), for all of that biologic's approved indications: Crohn disease and ulcerative colitis in adult and pediatric patients, rheumatoid arthritis in combination with methotrexate, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. The new drug would be the first biosimilar monoclonal antibody approved in the United States. Following the announcement, Medscape spoke with Seth Ginsberg, president and cofounder of the patient advocacy nonprofit organization Global Healthy Living Foundation (GHLF) and its arthritis division, CreakyJoints®, about patient attitudes surrounding biosimilar medications.

Medscape: What is the mission of CreakyJoints, and what inspired you to found the organization?

Mr Ginsberg: I was diagnosed with spondyloarthritis as a teenager and realized in my college dorm room that I didn't know where to go for support and engagement with other patients. So I cofounded CreakyJoints, now in its 17th year. It has evolved into the go-to source for more than 100,000 arthritis patients and their families worldwide who are seeking education, support, advocacy, and patient-centered research.

Medscape: What was your involvement in the FDA public meeting on the proposed infliximab biosimilar?

Mr Ginsberg: GHLF, through its online patient community CreakyJoints, was allotted time to speak during the open public comment period. It was during this time that we offered our organizational position in favor of biosimilars and relayed the hopes and fears about biosimilars shared by many of our patients.

Medscape: What exactly are biosimilar medications, and how many have been approved to date?

Mr Ginsberg: We are focused on biosimilars for autoimmune diseases such as arthritis. No biosimilars have been approved yet for arthritis in the United States. On February 9, the advisory committee recommended approval for the first one, a biosimilar for infliximab (Remicade). We spoke in favor of this recommendation, but we would have preferred that the committee followed Canada's lead and not recommended approval of it for Crohn disease.

Medscape: From a patient advocacy perspective, what are the potential benefits and drawbacks of biosimilar medications?

Mr Ginsberg: If biosimilars achieve the cost savings predicted, they should open the market to patients with insurance that didn't cover the innovator biologic. For this to happen, the savings have to go to the insurance company so it can afford to offer the biosimilar without demanding a high deductible or copay, as well as the patient, who will pay less. If these reductions are not realized by both the patient and the insurer, the uptake will be less. Biosimilars are substantially similar to the innovator biologic they mimic. The benefit of this class of medication is the ability to live a life restored to near normal, despite autoimmune conditions of the joints, skin, and/or gut.

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