Sandoz wins EU approval for Remicade biosimilar

By Flora Southey

- Last updated on GMT

The European Commission has approved Sandoz’ Zessly (infliximab), a biosimilar version of J&J’s Remicade.

Infliximab is designed to block the action of tumour necrosis factor (TNF)-alpha and inhibit inflammation in patients with some gastroenterological, rheumatologic and dermatologic diseases.

Sandoz​ – a Novartis​ company – acquired the rights from Pfizer for the development, commercialisation and manufacturing of Zessly in the European Economic Area (EEA) in February 2016, a spokesperson told us.

Pfizer​ retains the rights to the infliximab biosimilar in the US, where it received regulatory approval for Inflectra in April 2016​. The firm went on to receive US Food and Drug Administration (FDA) approval for its second infliximab biosimilar Ixifi in December 2016​.

Pfizer also holds rights for the biosimilar in countries outside of the EEA.  

The announcement marks Sandoz’ sixth biosimilar approval, after Omnitrope (somatropin), Binocrit​ (epoetin alfa), Zarzio/Zarxio​ (filgrastim) and Erelzi​ (etanercept).

And the firm said it expects to launch additional biosimilar in oncology and immunology therapy areas over the next two years.

In January, Sandoz submitted​ a proposed version of AbbVie’s Humira (adalimumab) to the FDA for review, and announced​ an agreement with Biocon to develop and manufacture third wave biosimilars.

Earlier this month​, the FDA rejected Sandoz’s biosimilar version of Biogen and Roche’s Rituxan (rituximab).  

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