Sandoz wins EU approval for Remicade biosimilar
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).
