The first generic drug, that is, the first generic drug
approved for marketing.
In recent years, under the background of encouraging innovation at the national level, head pharmaceutical companies with high research and development levels have been actively laying out innovative drugs while continuing to promote the work of
"grabbing the first imitation".
Recently, Fuyuan Pharmaceutical's application for the listing of fusidic acid cream submitted by Fuyuan Pharmaceutical co.
, Ltd.
in the form of 4 categories was accepted by the CDE
.
According to the data, fusidic acid cream is a kind of antibiotic topical drug, suitable for various bacterial skin infections, such as abscess, furuncles, paronychia, trauma co-infection, whiskers, sweat adenitis, erythritis, folliculitis, acne vulgaris, eczema co-infection, ulcer co-infection, etc
.
In 2021, the sales scale of the product in China's three major terminal and six major markets will be close to 400 million yuan, an increase of 21.
7%
year-on-year.
At present, there are fewer enterprises with fusidic acid cream production approvals, and from the perspective of manufacturer competition pattern, Aomei Pharmaceutical has an exclusive market share of more than 70%.
If the generic drug of Fuyuan Pharmaceutical can be successfully approved for listing, it may become the first one to be evaluated
.
Compared with innovative drugs, the development of the first generic drug is less difficult, and after listing, it is often able to quickly seize more markets; And it is expected to quickly replace expensive original products with price advantages, win the market profit highland, and have more advantages
than follow-up followers in pricing policies.
Therefore, in China, in recent years, the first generic drug has become the focus of
more and more pharmaceutical companies' research and development layout.
According to the data, NMPA approved a total of 68 generic drugs (92 specifications) for marketing this year, which are deemed to have passed the consistency evaluation, of which 39 drugs were approved
for the first imitation.
Among them, from the perspective of enterprises, Hengrui Pharmaceutical and Kelun Pharmaceutical have gained a lot
.
Hengrui Pharmaceutical has successively won 6 first generic drugs
such as nimodipine oral solution, ondansetron oral dissolved membrane, acetaminophen mannitol injection, gadolinium butanol injection, dequafosso sodium eye drops and tacrolimus sustained-release capsules this year.
It is worth mentioning that among the 6 first imitations, nimodipine oral solution, ondansetron oral dissolving film, tacrolimus extended-release capsules, acetaminophen mannitol injection are new dosage forms
.
In addition, Kelun Pharmaceutical (including subsidiaries) has also received the first imitation of 5 products since 2022, including trestigliptin succinate tablets, medium and long chain fat milk / amino acids ( 16 ) / glucose (36%) injection, medium and long chain fat milk / amino acids ( 16 ) / glucose (30%) injection, sildenafil citrate oral collapse tablets, glenol injection as the first imitation (containing dosage form first imitation)
In the context of vigorously promoting pharmaceutical innovation at the national level and encouraging the first generic drugs, the industry expects that pharmaceutical companies will accelerate the promotion
of "first imitation".
According to incomplete statistics, since 2018, about 200 products that have been declared for imitation listing and are under review (statistics by product name) have not yet obtained domestic approval for the same product, and it is expected to be approved for listing
after 2022.