Boehringer Ingelheim's Humira biosimilar accepted for review in US and Europe

By Gareth Macdonald contact

- Last updated on GMT

Boehringer Ingelheim's Humira biosimilar accepted for review in US and Europe

Related tags: Pharmacology, Food and drug administration

The EMA and US FDA have agreed to review a candidate Humira (adalimumab) biosimilar developed by Boehringer Ingelheim.

The drug – known as BI 695501 – is the first biosimilar the German firm has had accepted. Data​ from a Phase III trial indicate it is as safe and effective as Humira for the treatment of rheumatoid arthritis.

Spokesman Ralph Warsinsky told us “Biosimilars represent a new and exciting pharmaceutical sector, which is well aligned with our company strategy of providing more treatment options to the broader population.​  

We are exploring the long-term potential of biosimilars, which we believe will contribute significantly to the future sustainability of healthcare systems around the world and believe high quality biosimilars will provide healthcare providers and patients with more treatment options​.”

He added that: “We believe that value extends beyond the product, so we proactively seek strategic partnerships and innovative collaborations to improve the experience of patients, providers and payers with biologics​.”

Boehringer Ingelheim operates biopharmaceutical manufacturing sites in Biberach, Germany, Vienna, Austria, Fremont, US and Shanghai, China.

Humira market

Research by PNS Pharma​ suggests that at least 33 versions of Humira are being developed, 10 of which are in late phase clinical trials.

Humira generated revenue of $14bn for US drug manufacturer Abbvie in 2015​, an increase of 8.6% on the previous year. The firm has not reported its 2016 results.

Some Humira biosimilars have been approved – notably Amgen’s Amjevita which was cleared in the US in September​.

However, the only products launched to date are Torrent Pharmaceuticals’ Adfrar and Zydus Cadila’s Exemptia, both of which are available in India.

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