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Prestige Biopharma Obtains Russian Approval for Breast and Gastric Cancer Drug 'Tuznue'

[비즈한국] It has been confirmed that Prestige Biopharma950210 has received approval in Russia for its breast and metastatic gastric cancer treatment, 'Tuznue' (generic name: trastuzumab). While the approval process for Tuznue in Russia was previously known to be in the final stages, it was belatedly discovered that the drug was approved in Russia in September of last year, coinciding with its authorization by the European Commission (EC).

According to the Russian Ministry of Health's State Register of Medicines on the 17th, Prestige Biopharma received product approval for Tuznue from the Russian Ministry of Health on September 9 of last year. The Russian pharmaceutical company Pharmapark filed the application and was assigned registration number 'ЛП-006813'.

Pharmapark will be responsible for the production and distribution of Tuznue in Russia. In April 2019, Prestige Biopharma licensed the exclusive commercialization rights for Tuznue in the Russian region to Pharmapark.

Pharmapark has begun preparations for commercialization in Russia by receiving the active pharmaceutical ingredient (API) of Tuznue from Prestige Biopharma. Between August 15 and September 16, Prestige Biopharma supplied 1.7 billion KRW worth of Tuznue DS (drug substance) to Pharmapark. This accounts for approximately 12% of Prestige Biopharma's consolidated revenue of 14.3 billion KRW for the period from July 2024 to June 2025 (fiscal year ending in June). A Prestige Biopharma official stated, "Pharmapark will produce and sell the finished product (DP) using the DS supplied by Prestige Biopharma," adding, "We will also receive separate royalties based on sales figures once Pharmapark begins selling Tuznue."

Tuznue is the first pharmaceutical product to receive marketing authorization for Prestige Biopharma, a company currently developing biosimilars and new drugs for pancreatic cancer. As a biosimilar to Herceptin, the market size is estimated at 3.3 billion USD in global sales last year, according to market research firm Global Market Insights. Other products already launched globally include Celltrion's068270 'Herzuma', Samsung Bioepis' 'Ontruzant', Amgen's 'Kanjinti', Pfizer's 'Trazimera', and Mylan's 'Ogivri', while Alteogen196170 also received approval from China's National Medical Products Administration for its Herceptin biosimilar 'ALT-L2' last July.