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Randi Hernandez was science editor at Pharmaceutical Technology from September 2014 to May 2017.
Although switching has occurred in European markets for some biosimilars, most biosimilar manufacturers will focus on securing new users, according to Merck.
During a Q4 call with Merck, executives admitted the company's market share for Remicade (infliximab) has begun to dwindle. Remicade's share of the market decreased 5% (from 90% to 85%) from the third quarter to the fourth quarter.
Merck’s Adam Schecter, executive vice-president and president, global human health said during the call that the percentage of new patients that will use biosimilars is "going to only grow over time," and noted that currently, approximately 10% to 20% of the biosimilar business per year is new patients. "We are seeing substitution of existing patients in some smaller markets, such as the Nordics. At this point in time, we’re not seeing it in the larger markets. But we continue to anticipate that the impact of biosimilars is going to accelerate as we go into 2016, as there are more and more new patients coming into the market and they become a larger percent of the sales."
In fact, Merck reported lower-than-expected sales in the fourth quarter; Remicade sales fell 29% in this period. Of all of Merck's drugs, Remicade was associated with the largest loss in the quarter. The company's largest gain was in another biologic category: Sales of Gardasil and Gardasil 9 increased a whopping 40% over the fourth quarter.
Celltrion's Remsima and Inflectra biosimilars launched in the European market in early 2015. Celltrion predicted that over time, biosimilars would produce the biggest savings in France, Germany, and the UK. Additionally, the approval of a biosimilar Remicade in the United States may be occurring soon. Celltrion said FDA is scheduled to hold a committee meeting Feb. 9, 2016 to review and discuss Remsima’s approval in the North American market.
“Given that Remsima has already been approved in 67 countries including those in Europe, the biosimilar drug is expected to be approved in the US as well,” Lee Seung-ho, NH investment and securities analyst, told the Korea Herald.
Sources: SeekingAlpha, Korea Herald, Merck