SDA to Accelerate the Review and Approval of 48 Overseas Marketed Drugs

The State Drug Administration of China (SDA) issued the Notice on Soliciting Opinions on the List of Clinically Imperative New Drugs that are Marketed Overseas on August 8, 2018, with the list including Alectinib Hydrochloride and 47 clinically imperative new drugs that are marketed overseas, which are mainly drugs for rare diseases and drugs for prevention and cure of diseases that seriously threaten life or affect life quality. Products involved in the list are analyzed here and drugs that have similar Chinese-produced varieties are indicated here. According to the preliminary data, Novartis has 4 and Gilead and Pfizer separately have 3 among the 48 drugs.

I. 4 drugs have been marketed in China among the 48 drugs

By comparing the notice issued by the SDA, the enterprises that conduct relevant registration applications with CDE, and the public data, MSD’s Pembrolizumab, Pfizer’s Palbociclib, Sanofi’s Teriflunomide, and Amgen’s Evolocumab have been approved for marketing in China, and Chinese enterprises have laid out innovative drug, biosimilar or generic drug corresponding to those 4 drugs. My suggestion is that Chinese enterprises should receive stronger support for their drug development.

II. 9 need to be reassessed among the 48 products

Besides the 4 products mentioned above, 9 products in the list are at early clinical stage, of which the development of generic drugs/biosimilars or products with same targets have been started by Chinese enterprises. My suggestion is that the SDA should assess the clinical progress and registration progress of the 9 products including Apremilast, Vismodegib, and Icatibant, etc. and corresponding Chinese products, and give priority to Chinese-produced varieties.

III. The marketing of rare disease drugs and blockbuster innovative drugs will be accelerated, however, patients’ ability to pay will be a big issue after the marketing

Among the 48 drugs, the drugs in the table below are at clinical stages or not applied for in China, and many rare disease drugs and blockbuster innovative drugs in the table will gain advantages in review and approval. It’s worth noting that for drugs in the list, 1. Enterprises should provide documents to prove the marketing approval in the EU, U.S. or Japan, or provide marketing documents of Japan, Hong Kong, S.A.R., China, Macau, S.A.R., China or Taiwan, China; 2. Submit relevant documents in strict accordance with CTD format;

3. Provide the consistency evaluation of efficacy and safety between Chinese and Asian people, and European and American people, which is very important. However, how to prove no ethnic differences, and how those without international multicenter data can do the safety consistency evaluation?

Among the 48 drugs in the list issued by SDA, there are many global blockbuster drugs, such as Evolocumab, gene therapy Luxturna, anti-PD-(L)1 antibody: Keytruda, antisense therapy: Nusinersen, and blockbuster antiviral drug Harvoni and Vosevi, etc. However, those blockbuster drugs have expensive costs, for example, the gene therapy: Luxturna is priced at USD 850,000 every year; even if it was approved for marketing, how many patients could afford such a high price?

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