Armlupeg (pegfilgrastim biosimilar) / Lupin - LARVOL DELTA

Lupin Receives Health Canada Approval for Biosimilar Pegfilgrastim (Lupin Pharmaceuticals Press Release) - "Global pharma major Lupin Limited...today announced that ithas received approval from Health Canada for its biosimilar Pegfilgrastim. This product will be marketed under the brand name Armlupeg and manufactured at Lupin’s Biotech facility at Pune, India."

Canada approval • Infectious Disease • Neutropenia • Oncology

Lupin’s Pegfilgrastim Biosimilar 351(k) Application Being Evaluated by FDA (Biosimilar Review and Report) - "...Lupin’s pegfilgrastim application was accepted on June 2 by the Food and Drug Administration....Based on the filing date, an FDA decision may be expected in Q2 2022. If approval is received, Lupin will be entering a crowded market as the fifth biosimilar pegfilgrastim."

BsUFA date • Neutropenia

Lupin : announces U.S. FDA acceptance for Pegfilgrastim Biosimilar application (Market Screener) - "Global pharma major, Lupin Limited (Lupin) today announced that the U.S. FDA has accepted the Biologics License Application (BLA) for its proposed biosimilar to Neulasta® (pegfilgrastim) through a filing using the 351(k) pathway. Pegfilgrastim has estimated annual sales of USD 3.66 billion in the U.S. (IQVIA MAT December 2020)."

NDA • Neutropenia

Lupin to launch etanercept and pegfilgrastim biosimilars the US (GaBI) - "India-based generics maker Lupin, which is expecting European approval for its etanercept biosimilar in March 2020, has announced plans to launch the drug on the US market soon after, alongside a pegfilgrastim biosimilar....Lupin is expecting to launch its etanercept biosimilar on the European market by July 2020, and aims to file for approval for both drugs in the US by the fourth quarter of the same year."

Biosimilar launch • NDA

Lupin plans to file etanercept, pegfilgrastim biosimilars in US by Q4FY20 (Moneycontrol) - "The company has set an aggressive filing time frame for Pegfilgrastim in the US. The company plans to file it in Q4FY20."

NDA