Mylan and Fujifilm Kyowa Kirin Partner to Bring Humira Biosimilar to Europe

Mylan and Fujifilm Kyowa Kirin Partner to Bring Humira Biosimilar to Europe

Mylan is partnering with Fujifilm Kyowa Kirin Biologics to commercialize a biosimilar of Humira (adalimumab) in Europe, offering a new treatment option to patients with conditions like juvenile arthritis (JA).

Fujifilm Kyowa Kirin developed the biosimilar. Under the agreement, Mylan will work to seek regulatory approval and commercialize the product in the European Union.

Humira is a tumor necrosis factor (TNF)-inhibitor aimed at treating multiple chronic inflammatory conditions. TNF-alpha is a cytokine involved in the inhibition of tumorigenesis and defense against infection. High levels of TNF-alpha have been associated with a range of inflammatory diseases, including juvenile arthritis.

In the European Union, Humira is approved to treat JA, rheumatoid arthritis, psoriatic arthritis, and other conditions.

Unlike generic drugs, which are an exact copy of their reference medicine and must have the same chemical structure, biosimilars are highly similar, but not exact copies, of the reference product they are designed to resemble.

According to the U.S. Food and Drug Administration, “Minor differences between the reference product and the proposed biosimilar product in clinically inactive components are acceptable. For example, these could include minor differences in the stabilizer or buffer compared to what is used in the reference product.”

Heather Bresch, CEO of Mylan, said in a press release that expanding access to therapies “through the introduction of biosimilars around the world is a key area of focus for Mylan.

“Our partnership with Fujifilm Kyowa Kirin Biologics for an adalimumab [Humira] biosimilar in Europe is an exciting advancement for Mylan and for patients who are living with chronic autoimmune conditions and need access to a high-quality, more affordable treatment option,” she said.

Rajiv Malik, president of Mylan, said the pharmaceutical company’s “strong regulatory commercial platform in Europe and scientific leadership in the biosimilars space make us an ideal partner of choice.

“These attributes, combined with Fujifilm Kyowa Kirin Biologics’ expertise in biologics, position the two companies to bring an adalimumab biosimilar to the European market in the near term,” Malik added.

In May 2017, the European Medicines Agency (EMA) accepted for review the marketing authorization application for the Humira biosimilar developed by Fujifilm Kyowa Kirin Biologics. The EMA is expected to make a decision on the biosimilar in the second half of 2018.

AbbVie’s Humira was approved for the treatment of adults and children with several chronic inflammatory diseases.

Two other Humira biosimilars have been approved in Europe since then, including Cyltezo, developed by Boehringer Ingelheim, and Imraldi, developed by Samsung Bioepsis.

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