Mylan boasts of 16 biosimilars in portfolio after Mabion rituximab deal

By Dan Stanton contact

- Last updated on GMT

Image: iStock/Marcio Silva
Image: iStock/Marcio Silva

Related tags: Genentech, Rituximab

Mylan has struck a deal to commercialise a version of Roche’s Mabthera in Europe made by Polish biotech Mabion using a 2,500L disposable bioreactor system.

Mylan paid Mabion $10m upfront for the commercial rights to its rituximab biosimilar candidate, CD20, in all EU countries and non EU Balkan states, but could pay the Poland-based biotech a further $35m through filing and approval milestones.

Mabion will manufacture the product from its biologics facility in Konstantynów Łódzki.

“This is a highly-advanced biotechnology drug production plant in Poland,”​ Mabion CEO Maciej Wieczorek told Biopharma-Reporter, a large-scale facility based fully on disposables technology and with a sterile product filling line based fully on robotic systems.

“Mabion is the first company in the world to cultivate recombinant CHO cell on an industrial scale, for which it uses Kuhner 2500l, a bioreactor based on disposable technology,” ​he continued.

Mabion is looking to partner across its biosimilar pipeline, with Wieczorek saying the firm “finds it very important to obtain such a partner or partners which allow it to effectively implement milestones and which will ensure the best conditions for the sale of our drug.”

Mylan’s biosimilar portfolio

The deal adds a version of Roche/Genentech’s Mabthera – sold as Rituxan in the US by Biogen – to Mylan’s biosimilar portfolio which, through various collaborations, gives the firm “one of the largest and most diverse portfolio,” according to president Rajiv Malik.

“We have access to a combined portfolio of 16 biosimilar and insulin analog generic products in development,”​ he told stakeholders during a Q3 conference call Wednesday. “We remain committed to robust investments in this portfolio.”

In the last week, Mylan has submitted a version of Roche’s Herceptin (trastuzumab)​ for review in the US, and a version of Sanofi’s Lantus (insulin glargine) in Europe​. Both were co-developed with Indian drugmaker Biocon.

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