Date: 2018-09-20
Type of information: Positive opinion for the granting of a Market Authorisation in the EU
Product name: Pelmeg® - B12019
Compound: pegfilgrastim - biosimilar version of Neulasta®
Therapeutic area: Cancer - Oncology
Action mechanism:
- protein/biosimilar. B12019, a biosimilar version of Neulasta® (pegfilgrastim), a pegylated form of the human granulocyte colony stimulating factor (G-CSF) analogue filgrastim. This granulocyte colony-stimulating factor (G-CSF) receptor agonist has been developed by Cinfa Biotech. The company was established by the spanish group Infarco in 2013 to build a pipeline of biosimilars for several indications in oncology and inflammatory diseases to address the growing need for affordable biologics therapies based on proven science, quality, safety and efficacy.
Company: Cinfa Biotech (Spain)
Disease: chemotherapy induced neutropenia
Latest news:
- • On September 20, 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive
opinion, recommending the granting of a marketing authorisation for Pelmeg®, intended to reduce the duration of neutropenia and the incidence of febrile neutropenia due to
chemotherapy. Pelmeg® will be available as a 6-mg solution for injection.
- The marketing authorization application was submitted in September 2017 and is supported by a comprehensive set of biosimilarity data from analytical, biofunctional and clinical studies comparing Pelmeg® and Neulasta®. The clinical development program included two studies, which confirmed the analytical and biofunctional similarity of Pelmeg® and Neulasta® in highly sensitive clinical study settings.
- • On October 4, 2017, Cinfa Biotech reported acceptance of the Marketing Authorisation Application (MAA) by the European Medicines Agency (EMA) for its lead development candidate B12019, a biosimilar version of Neulasta® (pegfilgrastim) to treat chemotherapy-induced neutropenia.
- The B12019 MAA is supported by a comprehensive set of biosimilarity data from analytical, biofunctional and clinical studies comparing B12019 and Neulasta®. Based on scientific advice from EMA, the clinical development program included two studies, which confirmed the analytical and biofunctional similarity of B12019 and Neulasta® in highly sensitive clinical study settings.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization:
Favourable opinion UE: 2018-09-20
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
