Armed with fresh PhIII data, Fujifilm biosimilar takes aim at Humira

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Biosimilar developers are queueing up to file copycat versions of AbbVie's Humira, the biggest-selling drug in the world, and another candidate now has late-stage data to back it up. 

Fujifilm Kyowa Kirin Biologics--a joint venture between Japanese companies Fujifilm and Kyowa Hakko Kirin--said its FKB327 biosimilar met its targets in a Phase III trial, which compared the drug to TNF inhibitor Humira (adalimumab) in moderate to severe rheumatoid arthritis.

The trial showed that there was no significant difference between FKB237 and AbbVie's drug in the number of patients who met the primary target in the trial--a 20% improvement in rheumatoid arthritis symptoms as measured by a common benchmark, ACR20 response. There was also no difference between the two drugs in terms of side effects, the JV said in a statement.

With $14 billion in sales last year, Humira is a critical product for AbbVie--accounting for almost two-thirds of the company's revenues--and unsurprisingly, it's a magnet for biosimilar developers. 

Amgen has already bagged an approval in the U.S. for its copycat version Amjevita (adalimumab-atto), forcing AbbVie to take legal action to block a launch that would threaten $8.4 billion of Humira's global revenues. Meanwhile, in Europe, Samsung Bioepis' SB5 version is under review by the European Medicines Agency (EMA) with a verdict due next year.

Meanwhile, India already has a Humira biosimilar, launched by the homegrown company Zydus Cadila. Other candidates with worldwide ambitions are in late-stage development at Novartis' Sandoz unit and Boehringer Ingelheim.

AbbVie insists it has patent protection for Humira in the U.S. until 2020 and in Europe through late 2018. It needs to keep competition off the market as long as possible as it works to bulk up sales from newer drugs, such as blood cancer therapy Imbruvica, acquired in its $21 billion Pharmacyclics buyout, and hepatitis C regimen Viekira Pak. AbbVie shares marketing rights on Imbruvica with Johnson & Johnson.

Some analysts are not convinced Humira biosims will hold off that long, however. Last month, Citi's Andrew Baum said he sees biosims starting to eat into Humira's sales in 2018, with a rapid falloff from a peak of $16 billion next year to $6 billion in 2022.

For now, Fujifilm Kyowa Kirin is not revealing its regulatory submission plans for FKB237, but because its Phase III study covered patients in the U.S., Europe and other countries such as Canada and Russia, it should be able to press ahead with filings in major markets promptly.

The Humira clone is one of a pair of biosims in late-stage development at Fujifilm Kyowa Kirin. It's also working on a copycat version of Roche's $7 billion-a-year cancer medicine Avastin (bevacizumab). Called FKB238, the biosimilar is currently in an international Phase III trial conducted by Centus Biotherapeutics, a JV set up with AstraZeneca last year.

At the time, AZ said the JV didn't signal a shift away from its primary focus on developing new drugs. It sees the biosim effort as a way to develop more affordable combination drug cocktails with other candidates in its pipeline, including its immuno-oncology prospect durvalumab. 

Related articles:
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Amgen's Humira biosim, Amjevita, passes FDA milestone on long road to market
EMA to review Samsung Bioepis' Humira biosim application 
Fujifilm presses biosimilars ambition
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