Biocon to Benefit From Global Sales of Mylan's Adalimumab Biosimilar, Hulio

Biosimilar developer Biocon said this week that it will share in the global profits of Hulio, an adalimumab biosimilar referencing Humira, that is licensed to Mylan by Fujifilm Kyowa Kirin Biologics.

Mylan entered into a partnership with Fujifilm Kyowa Kirin Biologics to commercialize the biosimilar in Europe in April 2018, and the European Commission authorized the product for marketing in September 2018. The next month, Mylan launched the product in Europe after having obtained a nonexclusive royalty license with Humira’s developer, AbbVie, for the use and sale of adalimumab in Europe. Through the deal, Mylan was granted a sublicense to sell the product.

In a May 7 statement, a Biocon representative said that commercialization rights to the biosimilar had been extended from Europe to the global marketplace. Under the terms of its global partnership with Mylan for monoclonal antibodies, Biocon will retain its economic interest in the biosimilar and will gain a share of profits from the global market.

While Hulio is not yet approved in the United States, in July 2018, AbbVie indicated that it had reached a settlement with Mylan that will grant the drug maker a license to sell the biosimilar in the United States beginning on July 31, 2023. Mylan will pay royalties on its sales to AbbVie.

Mylan and Biocon have partnered on other biosimilar projects to date, including a pegfilgrastim biosimilar referencing Neulasta. The biosimilar, Fulphila, has been approved in the European Union and in the United States; in the US market, the product launched at a 33% discount to the reference product, which is one of the deeper discounts achieved to date in the US biosimilar experience.

The Mylan—Biocon partnership currently has 1 additional biosimilar product approved for marketing by both the European Commission and the FDA: Ogivri, a trastuzumab biosimilar referencing Herceptin. The drug has not yet been launched in the United States.