Please login to the form below

Not currently logged in
Email:
Password:

Amgen's Humira biosimilars backed for EU approval

Amgevita and Solymbic prepare to challenge AbbVie’s blockbuster
Amgen

AbbVie's Humira (adalimumab) looks set to be on the defensive in Europe as well as the US this year, after the CHMP backed two biosimilar versions of the world's best-selling drug.

Amgen's biosimilars - Amgevita (ABP 501) and Solymbic - were recommended for approval by the EMA's scientific advisory panel in rheumatoid arthritis (RA), to treat moderate to severe RA in adults where methotrexate is inadequate and adults with severe RA who have had no prior methotrexate therapy.

Both are intended for a wide range of Humira's currently approved indications, including juvenile idiopathic arthritis, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn's disease and ulcerative colitis.

The two TNF inhibitors are not only the first biosimilars to receive a positive opinion this year, but the first versions of Humira to be backed by the CHMP.

Amgen's executive vice president of R&D Sean Harper said: “This represents another significant milestone for our biosimilars portfolio and is an important step in our effort to develop high-quality biologic medicines for patients suffering from chronic inflammatory diseases.”

However, Humira still has patent protection in the EU until April 2018 and so Amgen looks set to face an uphill struggle to launch the biosimilars in European markets.

The company is already engaged in a dispute over Amgevita in the US where it has recently been licensed, with AbbVie filing an infringement lawsuit against Amgen.

AbbVie has also sought an injunction to prevent its launch even after FDA approval.

The $13bn-a-year global brand, which currently accounts for 60% of AbbVie's revenues, reached its US patent deadline at the end of 2016 but the firm is looking to extend its protection until 2022.

Article by
Rebecca Clifford

30th January 2017

From: Regulatory

Share

Tags

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Merrill Brink International

Merrill Brink International is a leading provider of life sciences, legal, financial, manufacturing and corporate language solutions for global companies....

Latest intelligence

Precision paediatrics: Treating patients with CAR-T
Dr Stuart Adams specialises in using T-cell therapy to treat paediatric patients at Great Ormond Street Hospital. Here, he explains what it was like to develop and deliver a groundbreaking...
What does it mean to be an agile organisation
We spoke with Philip Atkinson to learn how healthcare and pharmaceutical companies can rapidly respond to changes in the market....
Battling breast cancer with precision medicine (Part 2)
Dr Mark Moasser treated breast cancer survivor Laura Holmes-Haddad (interviewed in part one) with an innovative precision medicine, which at the time was yet to be approved. Here he gives...

Infographics