FDA Approves Remicade Biosimilar

The FDA have just approved a Remicade biosimilar on Tuesday, April 5th. It will go by the name “Inflectra.” Inflectra becomes the second biosimilar drug to be approved by the FDA for the U.S. market. The drug was developed by Celltrion and will be co-marketed by Pfizer. It is a form of infliximab, but will carry the suffix “-dyyb” to differentiate itself. Inflectra will have major effect on Remicade’s market share which had $6.56 billion in sales last year.

With so much confusion about how Biosimilars should be coded and reimbursed, ReimbursementCodes continues to monitor FDA drug/indication approvals and CMS changes to ensure coding and reimbursement accuracy. Our database currently includes coding and pricing information for the first approved biosimilar Zarxio™. According to CMS on April 6, 2016, Inflectra will be given a Q-code Q5102 effective 7/1/2016.

Read the full story here.