The year
2021 was eclipsed by the Covid-19 pandemic. In our update for the first half of 2020, we had mentioned that
Covid-19 has not slowed down the speed at which generic active pharmaceutical
ingredient (API) manufacturers were submitting Drug Master Files (DMFs) to the
US Food and Drug Administration (FDA). That trend continued in 2021, when the
speed of DMF submissions to the agency remained similar to that witnessed in
the previous years.
In fact,
Type II DMFs, or DMFs for active pharmaceutical ingredients (APIs), were higher
in 2021 as compared to previous years. In the first quarter, FDA received 164
Type II DMF submissions, which rose to 165, 166 and 172 submissions over the
next three quarters. In all, 667 Type II DMFs were filed in 2021, as opposed to
662 in 2020, 633 in 2019 and 644 in 2018.
DMFs are
submissions made to the FDA by manufacturers who provide the agency with
confidential, detailed information about facilities, processes or articles used
in manufacturing, processing, packaging and storing of human drug
products.
Overall,
2021 saw a total of 913 DMFs (Type II, III, IV and V) being submitted. In
comparison, FDA had received 931 DMF submissions in 2020, 894 in 2019 and 979
in 2018.
View FDA DMF Filings in 2021 (Power BI Dashboard, Free Excel Available)
India
continues to lead DMF filings, followed by China
Country-wise
data on DMF filings at
the FDA tells us the potential of a country in the field of pharmaceuticals. At the company-level, with each DMF filing, a firm commits itself to manufacturing drugs in a facility that is aligned to the FDA’s rules and regulations.
This year
too, DMFs filed from India and China were significantly higher than those from
other countries. Expectedly, India continued to lead with 376 DMF filings.
Submissions from India were over twice that of DMF filings from China (at 159).
This is not surprising since the two countries have the maximum number of API
manufacturing facilities registered with the FDA.
As compared
to this, the United States had 52 DMF filings, Italy had 10, Spain and Taiwan
had 9 each, and countries like Canada, Israel, Japan and UK had five DMF
filings each.
View FDA DMF Filings in 2021 (Power BI Dashboard, Free Excel Available)
India’s MSN Labs leads DMF count
As in the
past, India's MSN Laboratories continued to lead the DMF filings by a single company with 43 submissions. MSN was followed by five other Indian companies — Dr. Reddy’s Laboratories filed 15 submissions, Hetero Group and Aurobindo Pharma 14, Metrochem API 13 and Aurore Life Sciences filed 12 DMF submissions.
The only
Chinese company in the top 10 by DMF count was Brightgene Bio-Medical Technology Limited with nine DMF submissions.
The maximum
number of DMF filings were for semaglutide (eight), followed by favipiravir (seven), apalutamide (six), sitagliptin phosphate (six) and tofacitinib citrate (six). Others like acalabrutinib, elagolix sodium, lenalidomide, liraglutide and pantoprazole sodium had five DMF filings each.
View FDA DMF Filings in 2021 (Power BI Dashboard, Free Excel Available)
Slow
assessment review, higher GDUFA fee
Although
there were 667 Type II DMFs filed with the FDA, only 194 (or 29 percent) had
their review completed. The GDUFA (short for Generic Drug User Fee Amendments)
fee associated with a DMF assessment review for 2021 was considerably higher — at US$ 69,921 — as opposed to US$ 57,795 for 2020. For FY 2022, the GDUFA fee has been revised upward to US$ 74,952 (an increase of US$ 5,031).
There are 42
products for which a DMF was filed for the first time. Among the patented
products which should expect generic competition are avatrombopag, encorafenib, esketamine hydrochloride, siponimod fumaric acid, tedizolid phosphate and vorapaxar sulfate.
In fact,
DMFs were also filed for products that are yet to receive an FDA approval. Some of these products are imeglimin, aviptadil, gimeracil, linzagolix choline, meglumine antimoniate, roluperidone hydrochloride and teneligliptin.
View FDA DMF Filings in 2021 (Power BI Dashboard, Free Excel Available)
Our view
The Covid-19
pandemic revealed how the global supply chain for pharmaceuticals is excessively dependent on India and China. As a
result, many countries across the world are making investments into expanding
their API production capacities. This should translate into more Type II DMF
filings from countries other than India and China.
Moreover, as the pandemic begins to wane and the FDA increases its inspections — both domestic and international — compliance issues are bound to increase. The US is planning to run a pilot program
soon that will test a system of unannounced inspections in India and China.
Companies in both India and China will need to increase their focus on
compliance if they wish to continue to be major contributors to the global
supply chain for pharmaceuticals. We can certainly expect more regulatory news
in 2022.View FDA DMF Filings in 2021 (Power BI Dashboard, Free Excel Available)
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