Having acquired a portfolio of biosimilar candidates in 2017, Fresenius Kabi says it needs “to earn the right to spend” further in the space through commercial sales.
Fresenius Kabi entered the biosimilar space in 2017 through the €656 million ($645 million) acquisition of Merck KGaA’s pipeline and Swiss-based R&D staff.
The total number of molecules in development have not been divulged, but Fresenius has said it is in the high single-digits and includes versions of AbbVie’s Humira (adalimumab), Amgen’s Neulasta (pegfilgrastim) and Roche/Genentech’s Actemra (tocilizumab).
In a conference call discussing Q4 results, management said the firm had €166 million ($188 million) of biosimilars expenses in the year 2018 and is reluctant to invest in further biosimilar candidates until its current pipeline has proven its worth.
“When we are talking about further development, what we do mean is to try and take that number of compounds that we currently have further along in the development process rather than adding additional ones to the pipeline,” Fresenius CEO Stephan Sturm told investors.
As to increasing biosimilars through M&A, Sturm said he did not want to rule it out but “it would have to entail negligible upfront and running expense for the time being.”
He continued: “You have heard our mantra, people at Fresenius need to earn the right to spend money first. So, I am keen to see the effects of the market launch of our first compound. I want to see first revenues. Ideally, I want to see more than just one product launch before we can raise our confidence level in spending more.”
Fresenius may not be waiting too long before seeing results.
Earlier this month, the firm received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommending the approval of its adalimumab biosimilar MSB11022.
The product is set to be launched under the brand name Idacio but will be competing not just with Humira but with several adalimumab biosimilars already launched in the market, including products from Sandoz, Amgen, Samsung Bioepis and Mylan.
“2019 will be a very important year for our biosimilars business,” said Sturm. “Our first market entries they will provide us with real life experience in structurally very different European markets. In our minds the European G5 [France, Germany, Italy, Spain, and the United Kingdom], will be crucial for our overall success in this region.”
He continued: “We feel we’re well-prepared, but we’ll obviously monitor the competitive landscape very closely.”