Sixth Humira Biosimilar gets US FDA approval – launch in 2023

July 29, 20200

String of biosimilar approvals continue with Mylan and Fujifilm Kyowa Kirin Biologics bagging the US FDA approval for their adalimumab biosimilar Hulio™, referencing Abbvie’s Humira for the treatment of a range of autoimmune conditions such as rheumatoid arthritis, ankylosing spondylitis, adult Crohn’s disease, plaque psoriasis and ulcerative colitis. The drug will be available in both prefilled syringe and auto-injectors. The approval is based on phase 3 trial ARABESC conducted by Fujifilm Kyowa Kirin Biologics. This marks the sixth approval for an adalimumab biosimilar in the US and like the other biosimilar developers, Mylan has entered into a patent license agreement with Abbvie to launch Hulio in July 2023. Mylan and Fujifilm Kyowa Kirin also partnered through a strategic agreement in 2018 for the commercialization of their adalimumab biosimilar in Europe and later expanded it globally.

Humira has undoubtedly been Abbvie’s treasure-trove contributing to more than 60% of its annual revenues. It has witnessed one of the longest reigns in the US market since its approval in Dec 2002 and enjoyed monopoly for about 20 years which is almost twice the usual exclusivity period of six to twelve years for patented drugs. The credit goes to the meticulously crafted patent fort around the product which includes over 100 patents in the US territory covering manufacturing processes, dosing, administration etc. On the other hand, the product did not enjoy the same exclusivity and patent protection in the Europe market and there are currently 6 approved biosimilars in the European market which resulted in a drastic price erosion for Humira. In some EU countries, Abbvie had to drastically slash prices to make its prices more favourable and competitive than the much cheaper biosimilar versions.

Abbvie has been the centre-stage of multiple patent lawsuits by biosimilar developers, successfully defending its patent strategies and settling the lawsuits agreed on the launch year 2023 for all biosimilars in return of royalty payments from the developers. Humira’s case is an exemplar drug success story and has definitely benefited millions of patients, however, drug pricing has always been a pain-point for both patients and manufactures for largely different motives. The potential competition with all 6 are slated for closely placed launch dates might result in steep price erosions which would offer some respite to patients. However, the onus is on manufacturers to leverage such competition in a positive way and create a win-win scenario for both the parties.

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