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.
Google trends, “biosimilar” search popularity, 11/2016
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.
Biosimilar Pricing May Disappoint
Early indications show that wholesale acquisition cost (WAC) of Inflectra may only be 15% discounted from branded Remicade ($946 per vial compared to $1,113). Compared to the discounts providers typically expect from generics, which can be up to 80% off WAC, Inflectra’s savings potential is disappointing, especially considering its lack of other obvious benefits.
Patients may not actually save money
Different payers and plans offer varying degrees of coverage for Remicade. For example, those who are eligible for Janssen’s copay card and patient assistance programs have had to pay as little as $5 out-of-pocket per treatment, while others pay upwards of $300 out-of-pocket per treatment. With varying financial incentives, patients might not be motivated to change. At this point it’s a hung jury whether biosimilars are disruptive or not.