Eye on Pharma: Fresenius Kabi Launches Biosimilar Adalimumab, Idacio

Fresenius Kabi, maker of the EU-authorized biosimilar adalimumab, Idacio, has launched its product in Germany. Fresenius Kabi has made the biosimilar available for sale in pre-filled syringe, pre-filled pen, and vial presentations.

The biosimilar developer gained the European Commission’s authorization to market its product in April 2019 based on a data package that included a comparison of the pharmacokinetics, safety, and immunogenicity of the biosimilar in healthy volunteers, as well as a phase 3 study in patients with moderate to severe plaque psoriasis that has reported results up to 52 weeks.

In a statement, Michael Schonhofen, PhD, president of the pharmaceuticals and devices division of Fresenius Kabi, said that “the launch of Idacio in Germany is an important milestone for our company and for all patients who will now have an additional option for access to high-quality treatment. We have a heritage of devotion towards providing high-quality and affordable products while upholding our tradition of putting patients first, which we are now carrying forward into our biosimilars offering.”

In an earnings call on May 2, Fresenius Kabi indicated that it was able to launch the product in its first market earlier than originally anticipated. The company also indicated that, as national authorities in other EU member states adopt the product, it will launch Idacio in additional markets over time, in line with its business plan. The company says that it is taking a market-by-market approach in response to the European Union’s heterogeneity.

Stephan Sturm, president and chairman of the company’s management board, said to investors that the company expected to see small sales in the second quarter, with “a bit of a ramp in the second half,” but reminded investors that Idacio’s contribution to the business will be limited during 2019. “Regardless, 2019 will be a very important year for our biosimilars business,” he said, “and our first market entries will provide us with real-life experience and important further insights to steer the business for the following years.”

Idacio joins a number of other biosimilar adalimumab products that are now marketed in Europe: Hyrimoz, Hulio, Amgevita, and Imraldi. While Fresenius’ biosimilar has not yet been approved by the FDA, Fresenius Kabi has struck a deal with AbbVie, maker of the reference Humira, that will allow the company to market its biosimilar in the United States in 2023.