Partners to commercialize Kesimpta biosimilar drug for MS in Europe
Expanded Alvotech, Advanz deal aims to broaden patient access to therapy
Alvotech, a developer of biosimilar medicines, is expanding its partnership with Advanz Pharma to commercialize three new products in Europe — one of them a biosimilar of Kesimpta (ofatumumab), a drug used for treating multiple sclerosis (MS).
Biosimilars are therapies that have no clinically meaningful differences from their approved reference products in terms of safety and effectiveness. Typically, however, their cost is less, which may make these medications a more cost-effective treatment option for patients.
The expanded agreement between the two companies builds on an existing partnership, which already covers several Alvotech biosimilars across European markets. The new products, biosimilars of Kesimpta for MS and two other reference therapies, will now be included under the agreement, per a joint press release from Alvotech and Advanz.
“We are very pleased to expand our partnership with Advanz Pharma,” said Róbert Wessman, CEO of Alvotech. “We now have agreed to launch proposed biosimilars to more than ten reference products in Europe, starting in 2025 and reaching beyond 2030.”
Under this agreement, Alvotech will develop and supply the medications for Advanz to register and commercialize. Advanz noted that its focus is on bringing specialty, hospital, and rare disease medications to European markets.
MS is a progressive neurological disease in which the immune system mistakenly attacks the myelin sheath, the protective covering that surrounds nerve fibers. Research indicates that B cells, a type of immune cell, play a key role in driving this autoimmune response. Nerve cell damage can lead to a variety of symptoms in people with MS, including cognitive problems and difficulty moving.
Kesimpta biosimilar drug aims to treat relapsing MS patients
Kesimpta, an approved treatment for adults with relapsing forms of MS, is an antibody that targets the CD20 protein present on the surface of B-cells. This triggers the death of these inflammation-causing cells, and reduces disease activity and slows disability worsening. The therapy, given as a subcutaneous, or under-the-skin, injection, is commercialized by Novartis.
It received U.S. approval in August 2020, followed by approval in the European Union in March 2021.
Currently, no biosimilars of Kesimpta are available on the market. Because biosimilars tend to be sold at lower costs than reference medications, Alvotech’s biosimilar has the potential to increase access to the therapy, according to the partners. The agreement with Advanz will help Alvotech bring this and two other biosimilars to patients in Europe, the company said.
“Importantly, two of these three new candidates address rare-disease indications, reinforcing our commitment to broaden access to rare disease and specialty medicines,” said Stefen Wagner, CEO of Advanz. “Biosimilars are a cornerstone of our growth strategy and this expanded collaboration positions us to deliver sustainable value for patients and healthcare systems alike.”
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