On November 13, Boehringer Ingelheim (BI) announced that the European Medicines Agency (EMA) granted approval for the marketing authorization of Cyltezo (Humira biosimilar) for the treatment of multiple chronic inflammatory diseases such as ulcerative colitis (UC).

This news comes after BI recently received approval from the FDA for Cyltezo in August. Although this sounds like great news for the company, BI cannot launch Cyltezo in the EU until October 2018 and in the US until 2023 due to AbbVie’s detailed patents of Humira. BI now faces the huge task of marketing Cyltezo appropriately to compete with Humira and other approved Humira biosimilars, Amgen’s Amjevita and Biogen/Samsung Bioepis’ Imraldi, in a crowded UC market.

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GlobalData believes that by pricing the drug strategically, BI can effectively exploit the high price tags of branded biologics and cut into Humira’s market share.

UC is a chronic inflammatory disease of the colon or large intestine that usually initially manifests in the terminal part of the colon (rectum) and extends either to the left part of the colon or to the entire colon as the disease progresses. In 2015, there were over 601,000 diagnosed prevalent cases of moderate to severe UC globally across all ages. When patients fail to respond to conventional therapies, such as mesalamine, corticosteroids, and thiopurines, physicians prescribe biologics; these include tumor necrosis factor (TNF) alpha inhibitors—including Johnson & Johnson’s (J&J’s) Remicade (infliximab), AbbVie’s Humira, and J&J’s Simponi (golimumab)—and Takeda’s anti-integrin therapy, Entyvio (vedolizumab). Biologics offer an attractive alternative to conventional therapies, as these medications can help to both induce and maintain remission.

Despite insights from key opinion leaders (KOLs) interviewed by GlobalData that Remicade is the preferred TNF alpha inhibitor to use for moderate to severe UC patients, GlobalData forecasts Humira to generate $808M globally by 2019 in UC, making it the second most valuable biologic in the UC market. Additionally, KOLs noted that the cost of using TNF alpha inhibitors is expensive and believe that the introduction of more cost-effective biosimilars is needed in the market to drive down the prices of these therapies, which will ultimately reduce Humira’s market share.

Cyltezo will enter the EU market later than initially expected by BI, following Abbvie’s win in the patent litigation battle against Amgen. GlobalData forecasts that the total sales of Humira biosimilars in 2025 will amount to $211M globally. Cyltezo will face stiff competition from both Imraldi and Amjevita for market share in the EU, especially as it is the last biosimilar to gain approval in the EU. Although this approval is good news for BI, as it is the company’s first ever biosimilar, it must strategically and effectively market Cyltezo to differentiate the drug in a crowded market place in order to succeed financially.

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