Growing Competition for the World’s Most Profitable Drug as Multiple New Adalimumab Biosimilars Launch

Rothwell, Figg, Ernst & Manbeck, P.C.
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During the first quarter of 2021, multiple companies launched adalimumab biosimilars as a growing number of biosimilar players marketed their versions of the world’s most profitable drug, Humira®, which had sales of about $20 billion in 2020. While none have launched thus far, at least eight adalimumab biosimilars are due to launch by the end of 2023 in the United States, where Abbvie secured over $16 billion of its Humira® sales revenues in 2020.

On February 11, 2021, the European Commission (EC) granted marketing authorization for Celltrion’s YuflymaTM for use in treating thirteen chronic inflammatory diseases. This authorization is valid in all EU Member States and the European Economic Area countries Iceland, Liechtenstein, and Norway. According to Celltrion, YuflymaTM is the first adalimumab biosimilar with a high concentration, low-volume, and 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, adult Crohn’s disease, ulcerative colitis, hidradenitis suppurativa, psoriasis, and adult uveitis. According to Sandoz Canada, the company has completed the pan-Canadian Pharmaceutical Alliance (pCPA) negotiations for Hyrimoz®, which is the first step in securing public reimbursement.

On February 18, 2021, Fresenius Kabi Canada announced the launch of IDACIO® in Canada. IDACIO® received marketing authorization from Health Canada on October 30, 2020. IDACIO® is approved for treating all indications of the reference drug Humira® in the areas of rheumatology, gastroenterology, and dermatology. IDACIO® is the first biosimilar product introduced into North America by Fresenius Kabi.

On March, 23, 2021, LG Chem announced in a public filing that it obtained approval from Japan’s Health Ministry for its adalimumab biosimilar called Adalimumab BS MA. LG Chem is partnering with Mochida, which obtained exclusive sales and marketing rights over 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, intestinal Behcet’s disease, Crohn’s Disease, and ulcerative colitis.

In addition, Samsung Bioepis recently launched its adalimumab biosimilar in multiple markets. On February 18, 2021, it launched the adalimumab biosimilar 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, adult Crohn’s Disease, ulcerative colitis, hidradenitis suppurativa, plaque psoriasis, and adult and pediatric uveitis. On March 29, 2021, the company launched HadlimaTM in Australia in partnership with MSD Australia (Merck). In Australia, HadlimaTM is approved for treating rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult and pediatric Crohn’s disease, ulcerative colitis, hidradenitis suppurativa, and plaque psoriasis. On March, 15, 2021, Samsung Bioepis agreed with Yuhan Corp. to sell its adalimumab biosimilar 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 been using various life cycle extension strategies to maintain as much market share as possible. In addition to a “patent thicket,” which is the subject of a pending lawsuit, AbbVie has pushed for a shift to a new formulation that causes less pain, offered a wide range of doses for different types of patients, and obtained approval of new indications. However, in October 2018, with the launch of adalimumab biosimilar products in Europe, the sales of Humira® dropped by 30 percent in the following year. Thus, evidence from Europe suggests that biosimilar companies are likely to take a significant portion of Humira®’s market share with aggressive discounting.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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