Growing Competition for World’s Most Profitable Drug as Several New Adalimumab Biosimilars Launch | Rothwell, Figg, Ernst and Manbeck, PC
During the first quarter of 2021, several companies launched adalimumab biosimilars as a growing number of biosimilar players market their versions of the world’s most profitable drug, Humira.®, which had sales of around $ 20 billion in 2020. If none has been launched to date, at least eight adalimumab biosimilars are slated to launch by the end of 2023 in the United States, where Abbvie has secured $ 16 billion of his Humira® turnover in 2020.
On February 11, 2021, the European Commission (EC) granted a marketing authorization for Yuflyma from CelltrionTM for use in the treatment of thirteen chronic inflammatory diseases. This authorization is valid in all EU Member States and in the countries of the European Economic Area, Iceland, Liechtenstein and Norway. According to Celltrion, YuflymaTM is the first adalimumab biosimilar with a high strength, low volume, citrate free formulation.
On February 16, 2021, Sandoz Canada launched its adalimumab biosimilar, Hyrimoz®, in Canada. Hyrimoz® was authorized for sale in Canada by Health Canada on November 4, 2020. This biosimilar is approved for nine indications, including rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease in adult, ulcerative colitis, hidradenitis suppurativa, psoriasis, and adult uveitis. Sandoz Canada Says Company Completed Pan-Canadian Pharmaceutical Alliance (CPA) Negotiations for Hyrimoz®, which is the first step in obtaining public reimbursement.
February 18, 2021, Fresenius Kabi Canada ad the launch of IDACIO® in Canada. IDACIO® received marketing authorization from Health Canada on October 30, 2020. IDACIO® is approved for the treatment of all indications of the reference medicine Humira® in the fields of rheumatology, gastroenterology and dermatology. IDACIO® is the first biosimilar product introduced in North America by Fresenius Kabi.
On March 23, 2021, LG Chem ad in a public record that it has obtained approval from the Japanese Ministry of Health for its adalimumab biosimilar called Adalimumab BS MA. LG Chem is partnering with Mochida, which has secured exclusive sales and marketing rights to the biosimilar in Japan. Adalimumab BS MA is approved for nine indications, including rheumatoid arthritis, psoriasis vulgaris, psoriatic arthritis, pustular psoriasis, ankylosing spondylitis, polyarticular juvenile idiopathic arthritis, Behcet’s disease of the bowel, Crohn’s disease and ulcerative colitis.
In addition, Samsung Bioepis recently launched its biosimilar adalimumab in several markets. On February 18, 2021, he launched the biosimilar adalimumab HadlimaTM in Canada, in partnership with Merck Canada. In Canada, HadlimaTM is approved for the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease in adults, ulcerative colitis, hidradenitis suppurativa, adult and pediatric plaque psoriasis and uveitis. On March 29, 2021, the company launched HadlimaTM in Australia in partnership with MSD Australia (Merck). In Australia, HadlimaTM is approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease in adults and children, ulcerative colitis, ulcerative colitis, hidradenitis suppurativa and plaque psoriasis. On March 15, 2021, Samsung Bioepis agreed with Yuhan Corp. to sell its biosimilar adalimumab under the name AdalloceTM in Korea. Samsung Bioepis obtained the local license for AdalloceTM in 2017 and plans to launch the product in the first half of 2021.
AbbVie has used various lifecycle extension strategies to maintain as much market share as possible. In addition to a “thicket of patents”, which is the subject of a lawsuit pendingAbbVie lobbied for a new formulation that causes less pain, offered a wide range of doses for different types of patients, and gained approval for new indications. However, in October 2018, with the launch of adalimumab biosimilars in Europe, sales of Humira® fell 30 percent the following year. Thus, evidence from Europe suggests that biosimilar companies are likely to take a significant share of Humira®market share with aggressive discounts.