Remsima first biosimilar to be approved via Brazil's comparability pathway

Remsima is the first monoclonal antibody (mAb) biosimilar to be approved by the Brazilian Health Surveillance Agency (ANVISA), and is the first biological product to be given the nod based on comparability studies.

ANVISA’s rule #55/2010 marks out three pathways for biological products to be approved, two of which could be applied to copy-cat products: one based on comparability, and the other being an individual development pathway which requires a full dossier of data. (The guidance doesn’t use the term ‘biosimilar,’ rather ‘new biological product’ and ‘biological products.’)

The comparability pathway requires a number of documents, including a description of the analytical techniques used to detect potential differences between the biosimilar and the reference product plus data on the biological and physical-chemical characterization related to the quality attributes of the biosimilar.

Remsima (infliximab), a version of Janssen’s RA drug Remicade, is made by Korean firm Celltrion but being marketed in Brazil by Hospira. Sergio Teixeira, medical director for Hospira Brazil, explained the approval process:

“A robust package of comparative analyses involving Remsima and Remicade showing biosimilar infliximab's effectiveness and safety during rheumatoid arthritis treatment, as well as supporting data for ankylosing spondylitis, allowed us to extrapolate the data and gain approval from ANVISA to use the biosimilar in treatments for all approved indications of the reference product, without the need for additional clinical trials.” ​

Remsima is already available in other markets including Korea and the EU, where it became the first mAb biosimilar to be approved in July 2013.