mAbxience | Industry News

mAbxience opens `Unique´
Biosimilars Manufacturing Facility

Biosimilar drug developer, MAbxience, has opened a new manufacturing plant in Léon, Spain – marking one of the largest investments by a Spanish group in biotech in the country.

MAbxience acquired the plant, which originally belonged to Genhelix, in May 2014 for €11m and has since poured a further €14m into renovation plans. Since it was founded in2009, MAbxience has invested a total of €115m in biosimilar R&D.The plant is being described as “unique” because it offers the first “single-use” technology plant in Spain, focused solely on biosimilar monoclonal antibodies. This technology consists of using disposable bioreactors, which offer greater flexibility and enable MAbxience to save on production costs – a key part of its ability to provide its biosimilars at a higher discounted price once approved and brought to market.

Some research activities at the new plant have already begun, but MAbxience expects the unit to be fully equipped by December this year and fully functioning by January 2016.

Managing director of MAbxience, Carlos Bañado, said at a press conference in Léon on Oct. 15, “We have all the ingredients to make MAbxience a successful project.” However he noted that the market for biosimilars is relatively new and has many challenges – including novel and evolving regulatory guidelines.

The company’s goal is to address the issue of accessibility in Spain, Europe, Latin America (where MAbxience was born), and further afield, by providing cheaper version of expensive drugs – especially in immunology and oncology indications. MAbxience predicts that biosimilars manufactured at its new site will contribute approximate savings of €1.5bn for public authorities between now and 2020.

MAbxience, founded in 2009, has six biosimilars in development, the most advanced being a version of Roche Holding AG’s rituximab that is already available in Argentina. The company plans to start marketing its product with at least a 30% discount in Argentina and in Europe when approved.

Bañado predicts that biosimilars will take hold of at least 50% of the market share from branded, original products. He said, “We will see big discounts on the price of biosimilar products, starting around 30% and increasing, but these products will achieve a high market share in balance.” In terms of longer term competitive pricing, Bañado said it will depend on the number of players in the space.

MAbxience’s other biosimilar products in development include versions of Roche’s Avastin (bevacizumab), which is in clinical development, and preclinical programs for biosimilars of AstraZeneca PLC.’s Synagis (palivizumab); Amgen Inc.’s Enbrel (etanercept); AbbVie Inc.’s Humira (adalimumab); and an rFVIII product.

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