STADA Arzneimittel AG and Gedeon Richter Plc. announced that the two companies have signed a license and distribution agreement to commercialize Richter’s biosimilar Pegfilgrastim in Europe. According to the agreement STADA receives non exclusive distribution rights for the area of geographical Europe (excluding Russia), while Richter retains its rights to distribute and market biosimilar Pegfilgrastim worldwide.
Under the terms of the agreement in addition to a payment on the event of signing the contract, STADA is obliged to make further payments each depending on the progress of the project. With the start of marketing, STADA will report the resulting sales and make license related further payments to Richter.
A biosimilar medicine is a biological medicine, contains mostly protein as active ingredient, that is developed to be highly similar to an existing biological medicine (the ‘reference medicine’). The biosimilar medicines do not have any meaningful differences from the reference medicine in terms of quality, safety or efficacy.
Pegfilgrastim is a pegylated recombinant, human granulocyte-colony stimulating factor and is used in adult patients for treatment of neutropenia. This illness often accompanies cytotoxic chemotherapies and depicts a decrease in certain white blood cells. The active ingredient is a further development (a so-called second generation Filgrastim) of Filgrastim, which STADA has been selling as a biosimilar since 2014.
