The Ministry of Food and Drug Safety announced on the 2nd that it will operate the '2023 Biosimilar Commercialization Support Team' to increase the success rate of domestic biosimilar product development, accelerate their launch, and support exports.
As the patent expiration dates of major biopharmaceuticals approach, the biosimilar market is expected to grow rapidly. Since 2020, the support team has been providing customized assistance to domestic biosimilar developers. From 2019 to this year, there are seven major biopharmaceuticals with expiring patents, whose sales reached 59 billion USD as of 2018.
The support team plans to offer tailored consultations addressing difficulties and issues faced by domestic biosimilar developers throughout the entire process, including non-clinical, clinical, and approval stages. A Ministry of Food and Drug Safety official stated, "We will continue to provide systematic consulting based on regulatory science expertise to help domestic biosimilars be commercialized quickly and will do our best to support this."
Meanwhile, the Ministry is promoting the 'BRIDGE Project,' which aims to globalize domestic regulations to international standards so that domestic new technologies can become innovative products leading the global market. The project provides R&D coordination, close consultations with regulatory experts, priority application of global standards, and expedited reviews.
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