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By PharmaCompass
2023-08-17
Impressions: 3492
With the pandemic clearly behind us, generic active pharmaceutical ingredient (API) manufacturers demonstrated a renewed vigor in submitting Drug Master Files (DMFs) to the US Food and Drug Administration (FDA).
The first half of 2023 (H1 2023) saw significantly higher DMF submissions to the FDA than the average filings over the previous five years (2018 to 2022), which were at 315. A total of 410 Type II DMFs were submitted in H1 2023 as opposed to 350 in H1 2022, marking an increase of 17 percent. Type II are DMFs for drug substances (APIs) used to support abbreviated new drug applications (ANDAs).
Out of the 410 DMFs filed in H1 2023, only 62 (15 percent) had their review completed. Overall, a total of 558 DMFs (types II, III, IV and V) were submitted in H1 2023.
View FDA DMF Filings, Jan-Jun 2023 (Power BI Dashboard, Free Excel Available)
DMF submissions from India remain unchanged, China filings increase 46.5%
As always, DMFs filed from India and China were significantly higher than those from other countries. In 2022, we had seen DMF submissions from India drop by 10.6 percent. In H1 2023, DMF submissions from India remained unchanged at 174, as compared to the same period in 2022. However, in line with the trend witnessed in 2022, submissions from China increased by 46.5 percent to 148, as compared to the same period in 2022, when there were 101 submissions.
This year, Indian drugmaker Ami Lifesciences led the list of companies with the highest number of DMF submissions, at 14, thereby posting an increase of 367 percent in its DMF submissions as opposed to H1 2022 (when it had submitted three DMFs). MSN Labs, was at second position in H1, with 12 DMF filings.
Other top Indian companies were Cipla (nine), Hetero Group (nine), Global Calcium Private Limited (seven), Dr Reddy’s Labs (six), Chinese company Novoprotein Scientific (six), followed by American drugmaker Kactus Biosystems, Indian firm Lee Pharma and Spain-based Moehs Iberica with five submissions each.
View FDA DMF Filings, Jan-Jun 2023 (Power BI Dashboard, Free Excel Available)
43 DMFs filed for first time in H1 2023
During H1 2023, maximum number of DMF filings were for rivaroxaban (five), umeclidinium bromide (five), tafamidis (four), upadacitinib (four), followed by carfilzomib, dapagliflozin, degarelix acetate, eltrombopag olamine, ferric carboxymaltose and lutetium chloride (Lu-177) with three DMF filings each.
A total of 43 DMFs were filed for the first time, of which four had their GDUFA (Generic Drug User Fee Amendments) review completed. These include fedratinib hydrochloride, trientine tetrahydrochloride, levoketoconazole and zanubrutinib.
FDA approved several products for which DMFs were filed for the first time in H1 2023. These include trientine tetrahydrochloride, daprodustat and mavacamten. Two Indian firms (Biophore India Pharmaceuticals and MSN Laboratories) and an American drugmaker SS Pharma LLC (Subsidiary of Nuray Chemicals) filed DMF for the first time for trientine tetrahydrochloride. Orphalan’s Cuvrior (trientine tetrahydrochloride) was approved by the FDA in April 2022 for the treatment of adult patients with stable Wilson’s disease, a genetic disorder that prevents the body from removing extra copper, causing copper to build up in the liver, brain, eyes, and other organs. It became the first treatment approved for the condition in 52 years.
In February 2023, GSK’s Jesduvroq (daprodustat) was approved by the FDA and became the first oral treatment for anemia caused by chronic kidney disease for adults on dialysis. In April 2022, Bristol Myers Squibb’s Camzyos (mavacamten) was approved by the FDA. Camzyos is the first and only FDA-approved treatment for symptomatic hypertrophic cardiomyopathy, a heart disease caused by the thickening of the heart muscle.
View FDA DMF Filings, Jan-Jun 2023 (Power BI Dashboard, Free Excel Available)
Our view
GDUFA was reauthorized on September 30, 2022 (GDUFA III), with provisions that came into effect on October 1, 2022, and will last until September 30, 2027.
On July 28, 2023, FDA published user fee rates for the financial year 2024 for its prescription drug, generic drug, biosimilar and medical device user fee programs, and outsourcing facilities. For FY 2024, the fee for ANDAs has been increased by nearly five percent and for DMFs by around 21 percent.
While GDUFA III aims to reduce the number of assessment cycles for generics, support the development and approval of complex generics and help manufacturers resolve quality issues more quickly, the fee hike goes against the US government’s intent to bring down drug prices. With margins on generic drugs continuing to fall, someone will have to absorb this cost increase. Looks like it will be no one else but the consumer.
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Image Credit : FDA DMF Filings (Mid-2023 Recap) by PharmaCompass license under CC BY 2.0
“ The article is based on the information available in public and which the author believes to be true. The author is not disseminating any information, which the author believes or knows, is confidential or in conflict with the privacy of any person. The views expressed or information supplied through this article is mere opinion and observation of the author. The author does not intend to defame, insult or, cause loss or damage to anyone, in any manner, through this article.”
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