Last year, the number of product approvals for domestic biosimilars (biopharmaceutical copies) reached an all-time high.
According to the report on pharmaceutical products, pharmaceuticals, quasi-drugs, and medical device approvals released by the Ministry of Food and Drug Safety on the 29th, a total of 1,197 pharmaceutical products were approved or reported last year. This is a decrease of 11.3% compared to the previous year, continuing a decline for five consecutive years.
Among the pharmaceuticals, the equivalent biologics, which refer to biosimilars, received approvals for 18 items (10 ingredients), a 50% increase compared to the previous year. This is the highest figure since the first approval of a biosimilar in 2012. More than half of these, 13 items (7 ingredients), were developed domestically.
Celltrion had the most with eight items including 'Aptozimab (Tocilizumab)' and 'Steqeyma prefilled injection (Ustekinumab),' followed by Samsung Bioepis with five items including 'Episclimab (Eculizumab).'
The Ministry of Food and Drug Safety noted that there are numerous products from original developers approaching patent expiration, leading to expectations for active development of equivalent biologics by domestic corporations.
The number of generic drugs increased by 43 to 845 products compared to the previous year. The Ministry of Food and Drug Safety analyzed that the system appears to have stabilized, considering similar levels have persisted over the past three years since limiting the number of times clinical trial data can be used for different products to three in 2021. The number of approved and reported items, including generic drugs, decreased from 2,813 in 2020 to 1,614 in 2021, and has remained around 800 items since 2022.
The number of orphan drugs approved increased by two to a total of 39 items (26 ingredients) compared to the previous year. Among these, anti-cancer drugs, including treatments for acute myeloid leukemia, accounted for the largest number at 16 items.
The total number of medical devices last year reached 7,116 items. Among these, approvals, certifications, and reports for standalone software (Software as a Medical Device) including medical artificial intelligence products continued to increase for three consecutive years, reaching 164 cases.
The number of AI-based medical device approvals by the Ministry of Food and Drug Safety increased more than twofold over the past three years, rising from 47 cases in 2022 to 108 cases last year. In particular, products that received the first domestic approval in various medical fields stood out. Of the 41 innovative medical devices approved until last year, 33 items (80.5%) were Software as a Medical Device.
Additionally, as interest in skin beauty and cosmetics increases both domestically and internationally, medical devices related to skin, such as tissue restoration and wrinkle improvement, are being steadily approved.
Meanwhile, among the 659 approved or reported quasi-drugs, sanitary pads accounted for the highest proportion at 41.1% (271 items), followed by toothpaste and band-aids at 19.3% and 10.5%, respectively. The number of approvals and reports for domestic products was 567, representing 86% of the total approvals and reports (659), maintaining a dominant trend.