🇪🇺 ALYMSYS in European Union

EMA authorised ALYMSYS on 26 March 2021

Marketing authorisation

Application: EMEA/H/C/005286
Marketing authorisation holder: Mabxience Research SL
Local brand name: Alymsys
Indication: Alymsys in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Alymsys in combination with paclitaxel is indicated for first line treatment of adult patients with metastatic breast cancer. Alymsys in combination with capecitabine is indicated for first line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline containing regimens
Pathway: biosimilar
Status: approved

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Is ALYMSYS approved in European Union?

Yes. EMA authorised it on 26 March 2021.

Who is the marketing authorisation holder for ALYMSYS in European Union?

Mabxience Research SL holds the EU marketing authorisation.