Humira is a well-deserved "drug king" as it had been staying on the position of top of global best-selling drugs for six consecutive years from 2012 to 2017 since approved for marketing by FDA in 2002. Pharmaceutical enterprises such as Novartis, Amgen, Samsung Bioepis, Mylan, and Boehringer Ingelheim have invested in R&D of Humira biosimilars; among the 5 Humira biosimilars approved by the EU for marketing, Imraldi, Amgevita, and Hyrimoz may start to be marketed in the EU from October 16, 2018, while their marketing in the U.S. will not start until 2023, however, the biosimilars will undoubtedly erode sales of Humira!
As world’s first fully human anti-tumor necrosis factor alpha (TNF-α) monoclonal antibody developed by AbbVie, Humira (adalimumab) was first approved by FDA in 2002, and subsequently approved for marketing separately by EU EMA, Japan PMDA, and China NMPA in 2003, 2008, and 2010; it has 14 indications approved worldwide, including moderate to severe rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, moderate to severe Crohn's disease, psoriasis, and juvenile idiopathic arthritis, etc.
Humira’s sales have showed a rapid growing trend since approved in 2002; in 2012, it replaced Pfizer’s Liptor to become world’s best-selling pharmaceutical product upon USD 9.265 billion sales, and it has been maintaining growth of above 11.7% since 2009. Humira’s sales exceeded USD 16 billion in 2016, and reached USD 18.427 billion in 2017, bringing it the "drug king" title. Furthermore, Humira’s sales have reached USD 9.894 billion in the first half of 2018, and are forecast to exceed USD 20 billion in 2018!
The "drug king" title has brought many imitators of Humira, i.e., biosimilars. FDA announced the marketing approval of Amgen’s Amjevita on September 23, 2016, making it the first Humira biosimilar approved by FDA; Amgen announced EMA’s approval of its Amgevita on March 22, 2017, being the first Humira biosimilar approved in the EU. The U.S. FDA has so far approved 2 Humira biosimilars: Amjevita (Amgen) and Cyltezo (Boehringer Ingelheim), while the EU EMA has approved 5 Humira biosimilars, separately, Imraldi (Samsung Bioepis), Amgevita (Amgen), Cyltezo (Boehringer Ingelheim), Hyrimoz (Sandoz), and Hulio (Mylan/Fujifilm Kyowa Kirin).
The core compound patent that protected the period of market exclusivity of Humira in the U.S. has expired early at the end of 2016, however, AbbVie has extended the protection period of Humira to 2023 in the U.S. using its over 50 patents that protect its processes and preparations. Humira’s patent protection period will expire on October 16, 2018 in the EU; in other words, there will be Humira biosimilars marketed in the EU from October 16, 2018.
According to the agreement reached by Amgen and AbbVie on September 28, 2017, both parties would settle the patent infringement litigation involving Humira biosimilar Amgevita/Amjevita, AbbVie would withdraw its appeal, and Amgen would acknowledge that Humira’s patent is valid and pay patent fee based on sales of Amgevita/Amjevita; the agreement specifies that Amgen may sell Amgevita in the EU from October 16, 2018, and in the U.S. from January 31, 2023.
In addition, Samsung Bioepis reached a similar agreement with AbbVie on June 5, 2018, to have its partner Biogen sell Imraldi in the EU from October 16, 2018 and in the U.S. from June 30, 2023. Mylan/Fujifilm Kyowa Kirin announced on September 28, 2018 that EMA had approved Hulio and that they would sell Hulio "on or after October 16, 2018", however, there has been no relevant agreement reached by them with AbbVie announced; furthermore, AbbVie announced on July 17, 2018 that it reached an agreement with Mylan to permit sales of Hulio in the U.S. from July 31, 2023. AbbVie announced on October 11, 2018 that it had reached an agreement with Sandoz, ...
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