Sandoz’s pegfilgrastim MAA accepted by the EMA

Sandoz's MMA for Pegfilgrastim has been accepted by the EMA
Sandoz's MMA for Pegfilgrastim has been accepted by the EMA | shutterstock.com
Sandoz announced this week that the Marketing Authorization Application (MAA) for its biosimilar to Amgen’s EU-licensed Neulasta (pegfilgrastim) has been accepted by the European Medicines Agency (EMA).

Sandoz is owned by Novartis and is a worldwide leader in biosimilars. Pegfilgrastim is a long-term performing recombinant human granulocyte colony-stimulating factor (G-CSF).

Sandoz has had five biosimilars receive regulatory file acceptance in the past five months. This is a major step in the advancement of the company’s investment strategy in regards to its work with biosimilars. Sandoz has made the development of biosimilars a priority in 2016 and will continue to invest in products it can bring to its patients. The company has made a commitment to producing high quality biosimilars that are accessible by patients and can extend their lives.

Pegfilgrastim is a medicine that is prescribed for cancer patients to aid them with side effects of treatments. The medicine is not used in patients who have chronic myeloid leukemia and myelodyplastic syndromes. The drug is designed to decrease the length of neutropenia, which is a condition caused by low levels of white blood cells that combat infections, and the occurrence of febrile neutropenia, both of which are the product of chemotherapy.