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A division of a major Chinese biopharmaceutical company has received regulatory approval in Algeria for a biosimilar version of adalimumab, a medication used to treat autoimmune conditions such as rheumatoid arthritis and Crohn’s disease.
Algeria’s National Agency for Pharmaceutical Products authorized the biosimilar, developed by a Jiangsu-based subsidiary of a leading Chinese pharmaceutical group. This drug, widely known by its global brand name, is prescribed for various inflammatory diseases.
Biosimilars are highly similar to original biologic medications but tend to be more cost-effective. They enter the market after patents on the original drugs expire, providing more accessible treatment options.
The Chinese subsidiary considers Algeria, Africa’s largest country with nearly 2.4 million square kilometers and a population of 47 million, a vital market in its international expansion efforts for biosimilars. The company intends to collaborate with local partners to accelerate product commercialization.
Since 2015, China’s regulatory authority for medical products has tightened its approval process for biosimilars, demanding clinical trial results that confirm comparable effectiveness and continuous safety monitoring. By last year, more than 20 biosimilars had been approved in China, including this company’s adalimumab.
The company also offers other biosimilars in China, such as bevacizumab for lung and kidney cancers, rituximab for hematologic cancers and rheumatoid arthritis, and trastuzumab for breast cancer. It has additionally received approval for an internally developed drug targeting lung and uterine cancers.
Operations include extensive research, development, and manufacturing facilities located in Nanjing and Lianyungang, Jiangsu Province. These facilities adhere to standards set by the European Union and the U.S. Food and Drug Administration.
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