Among the latest opinions issued by the European Medicines Agency’s Committee for Medicinal Products for Human Use, perhaps the most eye-catching are recommendations for two biosimilar versions of Johnson & Johnson’s monoclonal antibody blockbuster Remicade.
The CHMP has backed Remsima from South Korea's Celltrion and Hospira's Inflectra, both of which contain the same active substance as Remicade (infliximab). They have been recommended for authorisation in the same indications as the J&J drug, ie a range of autoimmune diseases such as rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and and psoriasis.
This marks the first positive opinion for a mAb and fits with the EMA's product-specific guideline for the latter which has been in force since December 2012. As for all biosimilars, the agency notes that the emphasis is on demonstrating comparability to the reference medicine.
Full approval from the European Commission is the next step and if granted, the two biosimilars will dramatically reduce the price of infliximab, a $6 billion treatment for J&J and marketing partner Merck & Co. Ronny Gal, an analyst at Sanford Bernstein, issued a research note saying that "this is a watershed moment for the field of biosimilars” and predicting that generic MAbs could claim 40% of the European market by 2018.
However, he added that even if these copycat mAbs get approval, generics companies need to persuade doctors to switch from branded Remicade, saying "the task is now at hand to convince sceptical physicians". Andrew Baum at Citigroup also issued a note saying the decision could hit "the biosimilar risk premium" other biologics majors such as Roche, AbbVie and UCB benefit from.
J&J has patent protection on Remicade until February 2015 in the majority of EU countries, so Celltrion and Hospira will look to launch first in eastern and central European countries. It is also possible that the two companies could be hit with lawsuits from J&J regarding patent infringement.