Amgen's New Psoriasis Drug Apremilast Tablets Approved for Marketing in China

On August 16, the official website of the NMPA showed that Amgen's imported new drug, apremilast tablets, has been approved for marketing for the treatment of psoriasis.

Apremilast Tablets (formerly known as Apremilast Tablets) is a phosphodiesterase-4 (PDE4) small-molecule inhibitor. By inhibiting PDE4, it increases intracellular cyclic adenosine monophosphate (cAMP) levels, thereby elevating anti-inflammatory cytokines and downregulating the inflammatory response.

Chemical structure of apremilast tablets, Image source: Package insert

Apremilast tablets, developed by Celgene, were launched in the United States in 2014 (brand name: Otezla) and are currently approved in the US for three indications: the treatment of active psoriatic arthritis (PsA) in adults, moderate to severe plaque psoriasis, and oral ulcers associated with Behçet's syndrome.

In August 2019, Amgen announced the acquisition of apremilast for up to $13.4 billion, successfully incorporating it into its portfolio. According to Amgen's 2020 financial report, global sales of this product had already reached $2.195 billion. In February 2021, Amgen submitted a marketing authorization application for apremilast in China for the treatment of psoriasis, which was included in the priority review and approval program.

Apremilast is the first oral drug approved for psoriasis in the past 20 years, and the first oral medication approved for PsA in the past 15 years. Relevant study results indicate that for the treatment of moderate-to-severe plaque psoriasis, apremilast demonstrates efficacy comparable to that of Amgen’s blockbuster injectable drug, Enbrel (2019 sales reached $6.93 billion).

Such a blockbuster drug has naturally attracted proactive strategic positioning from companies in China. Prior to Amgen's submission of a New Drug Application (NDA) in China, four enterprises in China had already filed marketing authorization applications for generic drugs. CSPC Pharmaceutical Group and Simcere Pharmaceutical Group took the lead by submitting their applications in March and May 2020, respectively; however, both ultimately only received clinical trial approvals. The subsequent two applicants were Qilu Pharmaceutical and Zhaoke Pharmaceutical, both of which are currently still under regulatory review.

According to the Insight database, in addition to Amgen, the marketing authorization applications for apremilast tablets from six other companies in China are currently under review. Furthermore, eight companies have initiated bioequivalence (BE) trials, and 18 companies have received clinical trial approval, making intense future market competition for apremilast already foreseeable.

From the Insight Database (http://db.dxy.cn/v5/home/)