On Dec. 30, 2020, China National Health Commission (NHC) issued the Draft List of Second Batch of 19 Generic Medicines, encouraging pharmaceutical firms to develop and produce them. Medicines for chronic obstructive pulmonary disease and asthma are included in the list.
The 19 medicines were proposed by experts from the NHC, the Ministry of Science and Technology, the Ministry of Industry and Information Technology, the National Medical Products Administration and the National Intellectual Property Administration. The patents of these drugs will soon be expired in 2021 or 2020, with no fresh applications for registration.1
Details on the Draft List of Second Batch of Encouraged Generic Medicines
SN | Drug Name | Dosage Form | Strength |
1 | Arformoterol | Inhalation Solutions | 2ml: 15μg |
2 | Fluticasone Furoate and Vilanterol Trifenatate | Powder for Inhalation | 0.1mg Fluticasone, 25μg Vilanterol |
3 | Fluticasone Furoate, Umeclidinium Bromide and Vilanterol Trifenatate | Powder for Inhalation | 0.1mg Fluticasone, 62.5μg Umetium Bromide, 25μg Vilanterol, 0.2mg Fluticasone, 62.5μg Umetium Bromide, 25g Vilanterol |
4 | Clevidipine | Emulsions for Injection | 50ml: 25mg, 100ml: 50mg |
5 | Obeticholic acid | Tablets | 5mg |
6 | Plecanatide | Tablets | 3mg |
7 | Mirabegron | Sustained-Release Tablets | 25mg, 50mg |
8 | Elagolix | Tablets | 150mg, 200mg |
9 | Eliglustat | Capsules | 84mg |
10 | Macimorelin | Oral Solutions | 120ml: 60mg |
11 | Eslicarbazepine | Tablets | 200mg, 400mg |
12 | Perampanel | Tablets | 2mg, 4mg |
Oral Suspensions | 0.5mg/ml | ||
13 | Brivaracetam | Tablets | 10mg, 25mg, 50mg |
Oral Solutions | 10mg/ml | ||
Injections | 5ml: 50mg | ||
14 | Desvenlafaxine | Sustained-Release Tablets | 25mg, 50mg, 100mg |
15 | Tasimelteon | Capsules | 20mg |
16 | Tapentadol | Sustained-Release Tablets | 50mg, 100mg |
17 | Brimonidine Tartrate and Timolol Maleate | Eye Drops | 0.2% Brimonidine Tartrate, 0.5% Timolol Maleate |
18 | Cabazitaxel | Injections | 1.5ml: 60mg |
19 | Olaparib | Tablets | 150mg |
China has already promulgated a series of policies to encourage the production of generic drugs. In April 2018, the General Office of State Council announced Opinions Concerning Reforms of Policies to Improve the Supply and Utilization of Generics, encouraging the manufacture of generic drugs that are clinically necessary, have definite efficacy and are in short supply. It also advocated the manufacture of generic drugs for the prevention and treatment of major infectious diseases and rare diseases, for the treatment of public health emergencies, for children's use, and for which no application for registration has been filed one year before the patent expires.2
In December of the same year, twelve departments, including NHC, issued the Work Plan on Accelerating the Implementation of Policies on the Supply and Utilization of Generic Drugs, explicitly promising to publish a list of drugs that encourage copycats by the end of each year starting in 2020, and encouraging the research on key chemical and biological drugs in the list to be included in the relevant national science and technology plan.3
In Oct. 2019, NHC and other departments published the List of First Batch of 33 Encouraged Generic Medicines and required relevant departments to support these medicines in clinical trials, critical generic technology research and priority review and approval in accordance with relevant regulations.4
