Fresenius Kabi Chips Away at Neulasta Market in Germany

Fresenius Kabi, which earlier this week announced a biosimilar application filing with the FDA, said it has signed an agreement with medac, a Wedel, Germany—based pharmaceuticals company, to market the adalimumab biosimilar Idacio in Germany, which is where it was originally launched in 2019. Adalimumab is used for the treatment of plaque psoriasis, ankylosing spondylitis, Crohn disease, and ulcerative colitis.

Based in Bad Homburg, Germany, Fresenius Kabi has a broad slate of pharmaceutical products and announced on Wednesday that the FDA had accepted for review its biologics license application for the pegfilgrastim candidate MSB11455, which references Neulasta. Pegfilgrastim stimulates the growth of infection-fighting cells, and oncologists use it to treat febrile neutropenia, which results from chemotherapy.

Medac specializes in products for the diagnosis and treatment of oncological, urological, and autoimmune diseeases. Frensenius Kabi said in a statement today that the companies had agreed to cooperate on serving the market for rheumatological care in Germany, utilizing medac’s sales distribution network.

Fresenius Kabi said that the partnership has sales potential because medac provides methotrexate for the parenteral treatment of patients with chronic inflammatory diseases, and methotrexate is often paired with adalimumab as a treatment regimen.

“The partnership between Fresenius Kabi and medac will offer patients and doctors new benefits and synergies in therapy offerings as well as consulting,” Fresenius Kabi said in its statement.

Pegfilgrastim MSB11455

The FDA application for a pegfilgrastim biosimilar marks Fresenius Kabi’s first biosimilar regulatory submission for the US market. It has other plans for biosimilar launches in the United States, having already announced in 2019 that it had reached an agreement with AbbVie, the maker of reference adalimumab, to market Idacio in the United States in 2023.

AbbVie’s adalimumab (Humira) notched sales of $19.1 billion in 2019. It faces a field of multiple competitor biosimilars in 2023. Neulasta earned Amgen $665 million in 2019.