Boehringer files Humira biosimilar in US and EU

Boehringer Ingelheim has joined the competition to steal sales from AbbVie with a biosimilar version of Humira.

Boehringer has just filed its biosimilar of Humira (adalimumab), BI 695501, with the FDA and EMA.

Boehringer’s filings follow top-line results from a phase 3 study in patients in active rheumatoid arthritis, which were announced in October last year.

The news comes after AbbVie’s chief executive Richard Gonzalez conceded that biosimilars of Humira could be launched on patent expiry in Europe late next year, and in 2022 in the US.

Currently the world’s biggest selling drug, Gonzalez has predicted sales will peak at more than $18 billion by 2020, although the expectation is that the cheaper competition will start to eat into revenues after that time.

Gonzalez told the JP Morgan Healthcare Conference that a group of eight big selling drugs will replace the sales lost through biosimilar competition to Humira, between them generating up to $30 billion.

Amgen’s Humira biosimilar, Amjevita, has already been approved by the FDA, but cannot launch because AbbVie’s patents are still valid.

Amgen has also filed Amjevita in Europe, and the EMA is also reviewing Samsung Bioepis’ near-copy.

Ivan Blanarik, head of therapeutic area biosimilars, Boehringer Ingelheim, said: “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.”

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Ivan Blanarik

Samsung Bioepis has taken AbbVie to court in the UK, in an attempt to overturn patents protecting Humira.

The NHS in England spent over £416 million ($512 m) on Humira in 2015/16, far and away its biggest single drug cost – and one that health service payers will be eager to slash when the first biosimilars arrive.

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