Russian biosimilar of rituximab was approved for registration in Cuba

| By | Biocad, Biosimilars, Drug Registration

Cuban Ministry of Health (CECMED) approved for registration the biosimilar of rituximab manufactured by BIOCAD, a Russian biotech company. Supplies of this drug to Cuba are scheduled for the end of 2018. The company expects that the first year of sales will generate the revenues of no less than $3 million.

Cuba became the 13th country that completed the registration of Russian biosimilar of rituximab. In another 30 countries, the drug is in the process of registration in order to access their national markets. In addition to Cuba, the Russian pharmaceutical manufacturer plans to start supplies to three more South American countries by the end of this year, including Peru, Ecuador, and Argentina. South America has one of the most promising pharmaceutical markets, with the annual growth reaching 8%.

In Cuba, the original rituximab costs $350/100mg and $1680/500mg. An annual course of lymphoma therapy costs up to $19,000 to the state, and rheumatoid arthritis therapy costs up to $13,000. After Russian biosimilars of bevacizumab, trastuzumab, and rituximab became available in the international market in 2016-2017, the demand for Russian-made drugs has substantially increased. This allowed BIOCAD to reduce the cost of cancer therapy for patients in Southeast Asia, North Africa, and South America by up to 50%. Currently, total sales of original rituximab in the Republic of Cuba exceed $5 million.

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