CT scan showing Crohn’s disease in the fundus of the stomach. Credit: Samir at English Wikipedia.

Rival companies have lined up create biosimilars for Humira (adalimumab), which is currently marketed by US-based biopharmaceutical company AbbVie, as the European patent on the drug is expected to expire tomorrow, reports Financial Times.

Humira is used for the treatment of a wide range of conditions, including rheumatoid arthritis, psoriasis and Crohn’s disease.

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With the expiry of the patent, which has kept Humira away from generic competition for the past 15 years, rival pharmaceutical companies intend to replace the drug with their biosimilars with an aim to secure a position in the nearly $20bn global market.

The big name companies expected to enter the market with biosimilars for Humira, include Fujifilm Kyowa Kirin Biologics, Amgen, Sandoz, Biogen and Samsung Bioepis.

Based in Japan, Fujifilm Kyowa Kirin Biologics has granted an exclusive licence to Mylan for the commercialisation of Humira biosimilar Hulio in Europe.

All of these companies have received regulatory approval from Europe for the launch of their respective substitutes.

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“AbbVie welcomes the introduction of biosimilars that have demonstrated they are as safe and efficacious as their reference products.”

In a statement, AbbVie was quoted by Financial Times as saying that it “welcomes the introduction of biosimilars that have demonstrated they are as safe and efficacious as their reference products.”

However, the company has stated that “patients who are stable on their existing biologic therapy should not be switched to another product for non-medical reasons.”

According to the UK National Health Service (NHS), the most competitively priced suppliers of Humira biosimilars will gain a larger share of the market, while all other companies will have access to “some of the market upon receipt of a compliant bid to avoid dominance.”

An NHS commissioning document seen by the newspaper stated: “Our aim is that at least 90% of new patients will be prescribed the best value biological medicine within three months of launch of a biosimilar medicine, and at least 80% of existing patients within 12 months, or sooner if possible.”