Mabion will increase production capacity at its plant in Konstantynow Lodzki, in the Lodz Special Economic Zone (Lodz SEZ). This is the expectation of its partner Mylan, CEO Artur Chabowski said in an interview with Parkiet in December. This shows that Mylan has ambitious sales plans [for MabionCD20], Mr Chabowski noted.
On 3 January 2017 Mabion announced that it has received permission from the Lodz SEZ for a new investment. The company will invest at least PLN 20m (€4.5m) in the plant by the end of 2019, doubling its capacity.
In November 2016 Mabion granted Mylan Ireland exclusive rights to sell MabionCD20, a biosimilar version of MabThera (rituximab), in all EU countries and in the Balkans. The US market is twice bigger than the European and it is Mabion’s intention to sign a similar distribution deal for the US in 2017, Mr Chabowski said, noting that the Europe/Balkans contract is worth USD 45m (€10m).
The Konstantynow plant currently has two bioreactors with aggregate capacity of 5,000 litres, and there is space in the building to install a further two. Mabion wants the plant eventually to include several bioreactors, its CEO revealed.
Mabion intends to complete clinical trials of MabionCD20 next year and to file for marketing approval for the drug with the EMA in H2 2017. The product could appear on the European market at the turn of 2018 and 2019, Mr Chabowski said. It would be the company's first drug on the market.
The year 2017 will be a very important one for Mabion due to the anticipated completion of clinical trials of MabionCD20 and submission of the registration dossier, and gradual increase of its production, Mr Chabowski concluded.