- Merck and Samsung Bioepis announced on Wednesday that phase III trials of their investigational biosimilars of Amgen's Enbrel and Johnson & Johnson's Remicade met safety, efficacy, and pharmacokinetic equivalence endpoints in patients with moderate-to-severe rheumatoid arthritis who had already undergone methotrexate therapy.
- In two randomized, double-blind phase III trials, SB4 (biosimilar Enbrel) and SB2 (biosimilar Remicade) demonstrated equivalence to their originator products in terms of the American College of Rheumatology 20 percent (ACR20) response rate at weeks 24 and 30, respectively. SB4 elicited a 78.1% response rate versus originator Enbrel's 80.3% response, while SB2 elicited 64.1% response versus originator Remicade's 66% response.
- The companies will also be presenting data on the equivalence of a biosimilar of AbbVie's Humira at the ongoing European League Against Rheumatism conference. They are collaborating on biosimilars of five of the best-selling biologics in the world: Enbrel, Remicade, Humira, Roche/Genentech's Herceptin, and Sanofi's Lantus. Those products are all in phase III development and are expected to be filed for regulatory approval around the world between 2015 and 2016.
The biosimilar war is heating up. In fact, these trial results are going to take the battle into "scorching lava" territory.
One particularly interesting thing to note is that Merck is actually partnered with Johnson & Johnson on Remicade marketing. The fact that it's pursuing a biosimilar of that very product underscores just how big a part the company believes such products will play in the global pharma market.
There's already evidence from abroad about the potential of Remicade biosimilars to sweep up market share through deep discounts. For instance, in Norway, Celltrion's Remicade biosim Remsima has nabbed as much as 50% of the market thanks to discounts as high as 70%. Conventional wisdom states that biosimilar will, at most, be 20% to 30% cheaper than their originator products in general.
These products won't be marketed in every market if and when they receive approval, however. For instance, several of the biosimilar products won't be sold in Russia, Turkey, and the EU.