The year 2021 is likely to be remembered as the year of reduced marketing authorizations for drugs. This was greatly influenced by the changes in the market and the new regulations that were introduced last year. In particular, the pricing penalty imposed on indirect bioequivalence tested drugs and the restrictions set on consigned bioequivalence tests had greatly contracted the development of consigned generic drugs, significantly decreasing the number of approved items compared to the previous year.


◆ In 2021 = a total of 2,057 items were approved, recording the lowest-ever number of approvals during the past 4 years. 2,112 items were approved in 2018, 4,893 items in 2019, and 3,350 items were approved in 2020.

In the case of prescription drugs, the number of approvals is on a decline for 2 consecutive years since 2019. After reaching the peak of 4,193 in 2019, the number of approved prescription drugs decreased to 2,614 in 2020 and to 1,596 in 2021. The situation had worsened significantly due to the introduction of the penalty system that additionally discounts the price of drugs that did not directly conduct bioequivalence tests.

Moreover, the so-called "1+3 restriction” system that was introduced in July regulates the number of pharmaceutical companies that can share a company’s bioequivalence test to three other pharma companies, greatly reducing the foothold of CMO generics.

Therefore, the number of incrementally modified new drugs and generics that conduct their own bioequivalence tests is expected to increase greatly. OTC drugs are at greater peril. Compared to the past when OTC development increased when stricter drug pricing regulations were imposed on the industry, the number of approved items decreased to an unusual extent this year.


By month, approvals peaked in February with 441 with a flood of generics of the hyperlipidemia combo ‘Atozet Tab’ being approved. Since then, the average number of approvals remained in the 100 range, dipping to 88 in September.

◆OTC = Among the 461 OTC drugs that were approved in 2021,6 were data submission drugs, 63 were herbal medicines, and 211 were drugs subject to the Standard Manufacturing Criteria for Drugs, and others including generics accounted for 181.

The drugs ‘subject to the Standard Manufacturing Criteria for Drugs’ that accounted for 46% of the OTC drugs approved this year were allowed sale after simply reporting to the Ministry of Food and Drug Safety. The MFDS designates the type, standard, and limit of the ingredients, formulation, dosage·regimen, efficacy·effect, and precautions for such drugs so that they may be easily sold. It is the most preferred type of drug for pharmaceutical companies as it saves development costs.

The reality is that companies cannot invest so much into R&Ds of OTCs that have a small market size and require immense marketing costs.

◆Prescription drugs = Although generic drugs account for a substantial amount of the 1,596 prescription drugs that were approved in 2021, the number of new drugs and data submission drugs are also on the rise. Among the 45 new drugs that were approved last year, 3 were advanced biological drugs that were newly approved other than reregistered drugs, and 304 were data submission drugs. These accounted for 22% of all prescription drugs approved in 2021.

The trend was also evident in new drugs approvals. A record-high number of new active ingredients in 4 years was approved last year. Many new drugs and vaccines were introduced due to the DOVID-19 pandemic, and 4 homegrown new drugs were also approved last year.

Starting with Yuhan Corp’s anticancer drug ‘Leclaza’ in January, Celltrion’s COVID-19 treatment ‘Regkirona’ in February, Hanmi Pharmaceutical’s neutropenia treatment ‘Rolontis’ in March, and Daewoong Pharmaceutical's ‘Fexclu’ was approved in December.

Also, under the ‘Safety and Support Act for Advanced Regenerative Medicine and Advanced Biopharmaceuticals’ that was implemented in 2020, 3 new advanced biopharmaceutical drugs have entered the market. These cell therapy and gene therapy products would have been categorized as new drugs in the past.

All three advanced biopharmaceuticals that were newly approved this year are Novartis’ products. The first advanced biopharmaceuticals ‘Kymriah’ was approved in March, followed by ‘Zolgensma’ in May and ‘Luxturna’ in September. Novartis’ advanced biopharmaceuticals are all ‘one-shot’ treatments that are leading the pharmaceutical revolution. However, the drugs have a long way to go before receiving health insurance benefits in Korea as these one-shot treatments for rare diseases are very expensive.