The latest list of priority reviews! The global "pharmaceutical king" biosimilar drugs are listed

Medical Network February 28th On February 25th and 26th, the CDE website added 7 pieces of information to the publicity column of the proposed priority review. Among them, Cinda Bio's adalimumab injection is listed.

The battle for the first adalimumab-like drugs in China is becoming more and more fierce. At present, there are more than 20 domestic adalimumab-like drugs in research enterprises . Among them, Biaotaitai, Hisun Pharmaceutical, Cinda Bio, and Fuhong Hanlin are already in the application stage. Some analysts pointed out that from the perspective of the declaration progress, Baiaotai is faster than Haizheng, Haizheng is faster than Xinda, and Fuhong Hanlin just declared production in January this year.

Upon investigation of the CDE website, Biotech's adalimumab injection has been included in the priority review. Today, Cinda Bio's adalimumab injection is also undergoing a priority review and is expected to accelerate further.

Adalimumab was developed by Abbott, under the trade name “Humira”. It was approved by the FDA in December 2002 and has been approved for marketing in more than 90 countries around the world. In 2003-2017, the cumulative sales of the drug reached US$115.9 billion, and it has been sitting on the global “King of Medicine” for six consecutive years. In 2018, Humira continued to dominate, generating $19.936 billion in sales.

However, Humira's global growth rate was 8.4% in 2018, after the annual double-digit growth rate did not continue. Some analysts predict that 2018 may be the peak sales of adalimumab.

Humira's patent protection in Europe expired in October 2018, and several approved biosimilars were fully sold. Through the patent litigation settlement method, Humira's patent protection in the US market can still be maintained until 2023, but Aberdeen is facing increasing market pressure.

In 2009, Aberdeen's adalimumab was approved for marketing in China, and the product name was Xiu Meile. According to statistics from domestic sample hospitals , the amount of drug used in adalimumab in 2012 was 18.09 million yuan, compared with 22.08 million yuan in 2016 and 17.95 million yuan in 2017, down 11.5% from the same period. In the first three quarters of 2018, the amount of adalimumab in the domestic sample hospital was 12.09 million yuan, which is expected to exceed 17 million yuan for the whole year.

Compared with the global market, the current sales of adalimumab in China is not ideal. As more indications are approved in China, the market potential is still huge.