Brief Analysis of the Progress of Consistency Evaluation of Generic Drugs in 2021

The year 2021 just passed is the sixth year since the country officially launched the consistency evaluation of generic drugs
.

Data from the CPM New Drug Research and Development Monitoring Database shows that in this year, a total of 1,965 generic drugs of 573 companies passed the consistency evaluation or were deemed to have passed the consistency evaluation, a year-on-year increase of more than 70%
.

By the end of 2021, a total of 652 varieties (calculated by generic name + dosage form, the same below) have passed the consistency evaluation (including deemed approval, the same below), involving 3,700+ approvals from 780+ companies

CPM New Drug Development Monitoring Database

The content of the first reviewed varieties decreased

In 2021, the cumulative number of over-evaluated drugs increased from 426 at the beginning of the year to 652 at the end of the year, that is, among the nearly 2,000 over-evaluated generic drug approvals approved this year, 226 were first over-evaluated
.

In the previous year, the number of approved generic drug approvals was less than 60% of that in 2021, but the number of first-time approved drugs reached 215, only slightly lower than in 2021

In 2021, the cumulative number of over-evaluated drugs increased from 426 at the beginning of the year to 652 at the end of the year, that is, among the nearly 2,000 over-evaluated generic drug approvals approved this year, 226 were first over-evaluated

Figure 1.
The annual trend of the number of over-reviewed and criticized papers

Over-rated injections doubled

Among the approved generic drug approvals in 2021, the number of approvals for injection formulations accounted for 44%, which was exactly double that of the previous year
.

Mid-2020 is the time when the country officially starts the consistency evaluation of injections, so this result is logical

Among the approved generic drug approvals in 2021, the number of approvals for injection formulations accounted for 44%, which was exactly double that of the previous year

The number of consistent supplementary applications and new 3/4/5.
2 applications fell and rose, and the trend was very different

Judging from the application of generic drug consistency evaluation, the total number of acceptance numbers undertaken by CDE in 2021 has increased significantly year-on-year, with an increase of more than 30%, which is also higher than the previous year
.

However, the consistent supplementary applications and the new 3/4/5.

Judging from the application of generic drug consistency evaluation, the total number of acceptance numbers undertaken by CDE in 2021 has increased significantly year-on-year, with an increase of more than 30%, which is also higher than the previous year

Figure 3.