Rituximab is a monoclonal antibody to the CD20 protein, approved for the treatment of non-Hodgkin's lymphoma and B-cell chronic lymphocytic leukemia, as well as other diseases characterized by excessive, overactive or dysfunctional B cells.
The innovative rituximab drug is marketed worldwide under the trade names Rituxan™ and Mabthera™. The total world market for both biosimilar and originator rituximab therapeutics exceeded $8.5 billion in 2014.
Most of BIOCAD's rituximab sales were in Russia, where the company won a series of federal government contracts to supply programs that provide high-value, life-saving drugs to patients for whom the cost of treatment is prohibitive.
BIOCAD was able to meet the full annual demand of the Russian Government for this biopharmaceutical. Prior to 2014, Hoffmann-La Roche, a Swiss pharmaceutical company, had a monopoly on the Russian market for rituximab products.
BIOCAD's products cost less, but have similar efficacy and safety profiles to those of the original therapeutics. 2014 sales of BIOCAD's rituximab biosimilar, marketed under the trade name, Acellbia™, were twice the world market for biosimilars to rituximab for the previous four years, combined.
Biosimilarity of BIOCAD's Acellbia™ (rituximab) was demonstrated in a comprehensive comparability exercise that included analytical and non-clinical studies, as well as an international comparative clinical trial including centers in Russia, Ukraine, South Africa, India, and Columbia. These studies were designed in compliance with the European Medicines Agency's guidelines.
BIOCAD's biosimilar rituximab first received regulatory approval for sale on the territory of the Russian Federation in April, 2014. During the two year period, 2013-2014, BIOCAD concluded contracts for the sale and delivery of Acellbia™, valued at over $200 million, with distribution partners in Indonesia, Turkey, Armenia, Cambodia, Kenya, Kyrgyzstan, Morocco, Myanmar, Pakistan, South Africa, Ukraine, Uzbekistan, and Vietnam.
BIOCAD performs full-cycle manufacturing, from domestically produced, active pharmaceutical ingredient to finished dosage forms. BIOCAD's biosimilars program improves access to life-saving therapies by offering a more affordable treatment alternative, thereby meeting otherwise unmet patient need.