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Boehringer steps into Humira race with US and EU biosimilar filings

Published on 19/01/17 at 10:53am

Boehringer Ingelheim has just stepped into the ring to battle it out for a slice of Humira’s revenue with accepted filings to the FDA and EMA for its own biosimilar version of Abbvie’s best-selling drug.

Boehringer’s BI 695501 biosimilar reported positive top-line results in the treatment of rheumatoid arthritis last October, with the company filing for approval on the back of its strong showing – the company’s first biosimilar regulatory filings.

The patent on Abbvie’s blockbuster currently still stands, though that is set to expire in Europe next year and in 2022 in the US, meaning that cheaper contenders will be able to cut into Humira’s predicted sales of $18 million by 2020. Amgen’s own biosimilar Amjevita already holds approval by the FDA, but cannot proceed because of the active patents.

Ivan Blanarik, Boehringer’s head of therapeutic area biosimilars, commented: “We believe that if approved, BI 695501 can provide a valuable treatment option for the people affected by inflammatory diseases in the US and Europe. The acceptance of our first biosimilar regulatory filings by the FDA and EMA is an important milestone towards offering a high-quality treatment choice to patients and physicians while contributing to the sustainability of healthcare systems.”

Matt Fellows

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