China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that its generic version of Celgene’s Otezla (apremilast) has obtained marketing approval from the National Medical Products Administration (NMPA), signifying that it has passed the generic quality and efficacy consistency evaluation.
Apremilast’s Background and Clinical Necessity in China
Apremilast, an oral small molecule phosphodiesterase 4 (PDE4) inhibitor, was first approved in the US in March 2014 for the treatment of plaque psoriasis, active psoriasis arthritis, and oral ulcers associated with Behcet’s disease. In 2018, the drug was included in a batch of clinically urgently needed drugs in China that had been approved overseas. Apremilast, the first oral drug approved for psoriasis in the last two decades, was acquired by Amgen for USD 13.4 billion in August 2019 and received marketing approval in China in August 2021. The patent for the drug expired on March 19, 2023, opening the door for generic versions to enter the market. CSPC’s version is the first generic of the molecule to be approved in the country.
Implications of CSPC’s Generic Apremilast Approval
The approval of CSPC Pharmaceutical Group Ltd’s generic version of Otezla is a significant development for the company and the Chinese market. It offers a more accessible alternative for patients in China who require treatment for plaque psoriasis and related conditions. As the first generic version of the drug, CSPC’s apremilast is expected to increase patient access and potentially reduce the financial burden associated with the treatment of these chronic conditions.-Fineline Info & Tech
