Qilu Pharmaceutical Advances Toward China's First Generic of Over $2 Billion Blockbuster Apremilast

Recently, Qilu Pharmaceutical’s apremilast tablets, submitted for manufacturing approval as a Class 3 generic, have entered the administrative approval stage. The originator product was just approved for import this month, and currently no generic versions are commercially available in China. Data from Menet shows that since 2021, Qilu Pharmaceutical has received marketing approval for 19 products, 17 of which are generics.

Source: Official Website of the National Medical Products Administration

Apremilast is a novel oral, small-molecule phosphodiesterase 4 (PDE-4) inhibitor developed by Celgene (acquired by Amgen). It exerts its therapeutic effect by dose-dependently inhibiting the release of tumor necrosis factor (TNF)-α from human synovial cells. The product received FDA marketing approval in 2014, with global sales reaching $2.195 billion in 2020.

In addition to apremilast, other PDE-4 inhibitors currently marketed globally include crisaborole, doxofylline, and roflumilast. Apremilast is primarily indicated for psoriatic arthritis and psoriasis, crisaborole is mainly indicated for atopic dermatitis, and both doxofylline and roflumilast are indicated for respiratory diseases such as COPD. Among these, apremilast, crisaborole, and doxofylline have all been approved for import.

Apremilast Tablets NDA Submission Status

Source: MENET Consistency Evaluation Database

Amgen's apremilast tablets were approved for import in August 2021. Currently, eight companies in China have submitted marketing authorization applications for this product under the new registration classification. Among them, CSPC Ouyi was the first to file for production, but Qilu Pharmaceutical's product has been the first to enter the administrative approval stage. Who will ultimately secure the first generic approval? We shall wait and see.

Qilu Pharmaceutical Approved Products Since 2021

Source: MENET MED2.0 China Drug Review Database

Data from Menet shows that since 2021, Qilu Pharmaceutical has obtained marketing approval for 19 products, including two new drugs (both orally dissolving films) and 17 generic drugs submitted under the new classification system (three of which are first-to-market generics).

Sales Performance of 3 First Generic Drugs in China's Public Medical Institutions and Urban Physical Pharmacy Terminals (Unit: RMB 10,000)

Source: Menet Database

The three first generic drugs are Rasagiline Mesylate Tablets, Metformin and Vildagliptin Tablets, and Trifluridine and Tipiracil Tablets. The originator products for all three have been approved for import. Among them, Metformin and Vildagliptin recorded a combined sales revenue of nearly RMB 80 million in 2020 across urban public hospitals, county-level public hospitals, urban community health centers, and township health centers (collectively referred to as public medical institutions in China), as well as at urban retail pharmacy terminals in China.

Source: Menet Database, Official Website of the National Medical Products Administration, etc.

Note: The China Urban Physical Pharmacy Terminal Competitive Landscape Database is an expanded urban physical pharmacy database that continuously monitors all product categories and covers physical pharmacies in 293 prefecture-level and above cities across China (excluding county, township, and village physical pharmacies). The aforementioned sales figures are calculated based on the average retail price of products at the terminal. Data is current as of August 24. We welcome your feedback regarding any omissions or inaccuracies!