The EU made its first approval of a biosimilar mAb version of Remicade (infliximab) -- called Inflectra. The product is sponsored by Hospira and Celltrion. The companies expect to file in the US too in 2015. The new drug will now be able to compete in Europe's $2B market for Remicade, primarily for RA applications but also in other therapeutic areas addressed by the drug.
The approval of the first mAb is a BIG deal as many of the next round of blockbusters facing patent expiration in the next 5 years include many other big hitters in the mAb category. These would include drugs like Rituxin, Erbitux, Humira, Enbrel, etc. Many of these also are for RA applications. As the new biosimilar mAbs come to market, it will be very interesting to see what type of price savings are offered. Many analysts have speculated biosimilars would only drop prices by 15-20% compared to the brand name drug -- a far cry from the 80-90% drops often seen with small molecules. Yet in emerging markets, price drops with biosimilars have been much greater than 15-20% so it remains to be seen how the Western markets will set up. See Fierce Biotech.
Posted by Bruce Lehr Sep 10th 2013.