Mylan enters Humira biosimilar commercialization partnership

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Mylan enters Humira biosimilar commercialization partnership

By David Salazar - 04/17/2018
Mylan is working with Fujifilm Kyowa Kirin Biologics to commercialize a Humira biosimilar through a recently announced partnership. The Pittsburgh-based company said it would use its regulatory platform to submit Fujifilm Kyowa Kirin Biologics' Humira biosimilar for approval and commercialization in Europe.

Humira, indicated to treat multiple chronic inflammatory conditions, had European sales of roughly $4.1 billion for the 12 months ended Dec. 31, 2017, according to IQVIA data.

"Expanding access to biologics through the introduction of biosimilars around the world is a key area of focus for Mylan," CEO Heather Bresch said. "Our partnership with Fujifilm Kyowa Kirin Biologics for an adalimumab 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."

Mylan said it expects to receive a decision from the European Medicines Agency in the second half of 2018 for the Humira biosimilar. The agreement will see Mylan paying an upfront fee to Fujifilm Kiowa Kirin Biologics, with eligibility for a subsequent commercialization milestone payment and sales royalties.

"Expanding access to biologics through the introduction of biosimilars around the world is a key area of focus for Mylan," Rajiv Malik, Mylan president, said. "Our partnership with Fujifilm Kyowa Kirin Biologics for an adalimumab 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."