In a recent blog post, Allison Wu asks whether biosimilars are a disruption or a disappointment?
Branded as "Inflectra", this form of infliximab is developed by Celltrion and will be co-marketed by Pfizer. Despite steadily rising interest in biosimilars over the past 5 years, Inflectra is only the second true biosimilar drug to be approved by the FDA. Ever since the US Food and Drug Administration (FDA) approved a version of Remicade, biosimilars have been a hot spot on many hospitals' radars. Remicade is one of the first breakthrough biologic therapies used to treat autoimmune diseases like Crohn's disease and rheumatoid arthritis.
Derived from cells, Inflectra will not be identical to Remicade as a true generic. While Celltrion's recent trial of patients across five indications switching from Remicade to the biosimilar is encouraging, the trial's limited scope (Norwegian patients only) may cause hesitation. Many physicians are cautious of unique characteristics of US patients (higher BMI, diverse ethnicity, etc.) because some autoimmune disorders are notorious for nuances when it comes to these factors. Extrapolating results from a foreign patient sample is a leap of faith that some providers are just not comfortable with. The need for more data may delay adoption for many patients.
Patients Doing Well Likely Won't Switch
For patients who are severe enough for a biologic, their conditions are often difficult to stabilize. If they are doing well on Remicade, a switch can risk jeopardize that stability. Unless the patient wants change, there is little motivation for a physician to go out on a limb and switch them to Inflectra. A don't-rock-the-boat habit can be hard to break.