Mylan Forms Pact for Biosimilar to Roche’s Rituxan
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Mylan has signed a long-term development and commercialization agreement with Mabion, a Konstantynów Łódzki, Poland-based biopharmaceutical company, through its wholly owned subsidiary, Mylan Ireland, which gives Mylan exclusive rights to sell Mabion CD20, Mabion’s biosimilar referencing Roche’s MabThera/Rituxan (rituximab), a monoclonal antibody for treating non-Hodgkin’s lymphoma, in all European Union (EU) countries and non-EU Balkan states.

Mylan will support Mabion in Mabion’s effort to secure approval of its biosimilar by the European Medicines Agency (EMA). Under the agreement and subject to certain conditions, Mylan will pay Mabion an upfront payment of $10 million and additional milestone payments in the aggregate of up to $35 million, subject to filing and approval of marketing authorizations and commercial launch in key countries as well as royalties based on annual net sales. MabThera/Rituxan is one of Roche’s top five-selling drugs with 2015 sales of approximately CHF 7 billion ($7.1 billion).

Mylan has been intensifying its pursuit of biosimilars in the last year. In August 2016, the EMA accepted Mylan’s filing of a marketing authorization application for a proposed biosimilar referencing Roche’s Herceptin (trastuzumab), for certain HER2-positive breast and gastric cancers. Following that, in November 2016, Mylan submitted a biologics license application for its Herceptin biosimilar with its partner, Biocon, a Bangalore, India-based biotechnology company, to the US Food and Drug Administration. Mylan’s trastuzumab biosimilar is already being sold in 11 developing markets, including India, the company said. Herceptin, one of Roche’s top-selling oncology drugs, had 2015 global sales of CHF 6.5 billion ($6.6 billion).

Also in November 2016, Mylan and its partner, Momenta Pharmaceuticals, a Cambridge, Massachusetts-based pharmaceutical company, began a Phase I study for a proposed biosimilar to Orencia (abatacept), Bristol-Myers Squibb’s anti-arthritis drug. The proposed biosimilar, designated M834, is being developed in collaboration by Mylan and Momenta Pharmaceuticals. BMS’ Orencia is approved in the US, EU, and Japan for treating rheumatoid arthritis and approved in the US and EU for treating juvenile idiopathic arthritis. Orencia is a top-selling drug for BMS with 2015 worldwide sales of $1.9 billion.

Meanwhile, in July 2016, Mylan’s filing for a proposed biosimilar of pegfilgrastim was accepted for review by the EMA. Pegfilgrastim is the active ingredient in Amgen’s Neulasta, one of Amgen’s top-selling drugs with 2015 revenues of $4.7 billion. Pegfilgrastim is prescribed for cancer patients to help them with some of the side-effects of their treatment, including neutropenia (low levels of neutrophils, a type of white blood cell that fights infections) and febrile neutropenia (neutropenia with fever) that are a result of their chemotherapy treatment.

Source: Mabion

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