A biosimilar version of Remicade (anti-TNF drug) is the first mAb to be submitted to the EMA for review. Celltrion is believed to be the company making the submission, although this has not been formally revealed. Celltrion has conducted clinical trials with its version of the drug in 19 countries over the past 2 years. There are 16 -- yes 16 -- approved indications for Remicade. It is not known if Celltrion is seeking approval for only the RA indication (matching trials) or going for additional indications as well. Extrapolation of safety and efficacy data from one indication to others is allowed potentially so it is a pertinent question.
First Monoclonal Antibody Submitted to EMA for Biosimilar Approval.
The anti-TNF market is estimated to be worth $21 B. Analysts are torn as to whether a biosimilar version is a bigger threat to J&J's Remicade or whether a (humanized) biobetter version of the antibody will more likely prevail. J&J has its own humanized replacment called Simponi. Celltrion is betting on gettig share however and is submitting its application well ahead of Remicade's 2014 patent expiration date. Celltrion will also go to Korea and other emerging markets in Asia and Central/South America where Remicade is not under patent.
Now, we all wait to see how Celltrion's application does at EMA. More mAb biosimilar applications are expected to be submitted to EMA this year. Whether these have a huge impact on the market, depends upon how easily they are approved and whether companies like Celltrion (or Samsung) can make good on their promise to drop prices by 40-50% over the reference product. The race has begun in earnest now.
Posted by Bruce Lehr May 2nd 2012.
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