The US drugmaker made the comments after revealed that a 10% decline in Remicade sales to $557m combined with the strong US dollar had played a part in a 7% drop in revenue in the final three months of 2014.
For the full year, revenue from Remicade – which Merck sells worldwide apart from the US, Japan and China – fell 4% to $2.3bn. The firm attributed the decline to the impact of bisosimilar competition for the product.
Adam Schechter, president of global Human Health said the decline reflected biosimilar competition in smaller EU markets adding that “We will lose patent protection for Remicade this month across the remainder of our European markets.”
“We expect biosimilar competition to begin on patent expiration” Schechter continued, adding that while the firm thinks it will retain current Remicade patients it will face competition for new patients.
Schechter also said “there will be mandatory price reduction [for Remicade] in certain markets” citing countries where reference pricing is used like France and Spain as examples.
Another market where such cuts are likely is Norway, which has been assessing the anti-TNF market with an eye on biosimilars since 2013.
Several Remicade competitors have been launched in Merck markets in the past few years with and Ranbaxy’s Infimab in India and Hospira and Alvogen’s Inflectra (infliximab) in Bulgaria, Croatia, Estonia, Hungary, Latvia, Lithuania, Poland and Romania.
Celltrion is also expected to launch a Remicade biosimilar in Europe this year in collaboration with Hospira.
Hepatitis C
Merck & Co also spoke about the US FDA plans to rescind "breakthrough therapy" designation for the company's experimental combination treatment for hepatitis C in response to the approval of competitor products made by Gilead Sciences and AbbVie.
Roger Perlmutter, president of Merck Research Laboratories, said: “Breakthrough designation does not affect our filing strategy and the data are the data we have our Phase III data and we are moving along with our programme” adding that Merck intends to have further discussions with the US FDA.