Solid Sales for Monoclonal Antibodies in Rheumatoid Arthritis Treatment May Prove Biologics Can Overcome the Patent Cliff

mAbs Remicade is also the blockbusting pharmaceutical product across the entire industry. The approaching patent cliff seems not likely to knock these popular drugs off their position, in a market that is slow to accept new products.

The first three mAbs to be approved to treat RA—Humira, Remicade, and Enbrel—have consistently dominated RA drug sales since their market entry, in spite of the approval of debatably more effective mAb products since then. GBI analyst Dominic Trewartha stated, “Physicians are likely to exercise great caution when prescribing biologics, in part due to their potentially serious side effects. Rheumatologists in general are also quite conservative in their treatment patterns, which could explain why Remicade, Humira and Enbrel are doing so well, being the first mAbs approved for RA. In contrast, biosimilars are less likely to be prescribed. For this reason, the growth of the global market is expected to continue in spite of the impending patent expiry of three of the four top-selling RA mAbs in the US.”

The RA mAbs market in the United States, Japan, Germany, France, the United Kingdom, Spain, and Italy is expected to grow from USD 11.5 billion in 2011 to USD 15.7 billion by 2018. Mr. He continued, “None of the potential market entrants appear to offer any significant improvements to existing medications, and thus will not dramatically affect the market size in the coming years, leaving Remicade, Humira, and Enbrel to maintain their top-selling RA mAbs status.”

The costs and problems tied to bringing biosimilars to the market is also expected to restrict the number of biosimilars and their impact on drug pricing for RA mAbs, estimated to be as low as 10%.

GBI Research is a provider of business intelligence reports, providing data and forecasts based on the insights of key industry experts with the latest emerging trends.

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