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Biocon partner Mylan enters pact with Fujifilm to commercialise Humira biosimilar in Europe

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Biocon on Wednesday said its partner Mylan has entered into an in-licensing deal to accelerate commercialisation of biosimilar Humira developed by Japanese drug maker Fujifilm Kyowa Kirin Biologics for European markets.

Adalimumab – the biosimilar of Humira is indicated for patients suffering from various autoimmune disorders.

Mylan said its partner Biocon will receive economic benefit through this collaboration.

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Humira is the world's best-selling biologic medication and had brand sales of approximately USD 4.1 billion in Europe for the 12 months ending December 31, 2017, according to IQVIA.

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The European Medicines Agency (EMA) accepted for review the Marketing Authorisation Application of Fujifilm for its proposed biosimilar to Humira on May 18 last year. The company expects to receive a decision from EMA in the second half of 2018.

Under the terms of the agreement between the two companies, Fujifilm grants Mylan an exclusive license to commercialise the adalimumab biosimilar in Europe and will receive an up-front fee.

In addition, Fujifilm is eligible to receive a subsequent commercialisation milestone payment and sales royalties.

The two companies continue to negotiate for commercialising the product in additional territories.

"We believe that through this arrangement, Mylan could commercialise FKB's Adalimumab in EU around market formation. Biocon retains its economic interest in this arrangement vis-a-vis Mylan in line with its existing global collaboration with Mylan for monoclonal antibodies," a Biocon spokesperson said.

Biocon in collaboration with Mylan is separately developing Humira biosimilar for US and Europe. Currently, the drug is under global clinical trials and could take more time before it is ready for marketing authorisation filing with Europe and US regulatory agencies.

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