Tags : Pegfilgrastim

Pfizer Receives the US FDA’s Approval for its Nyvepria (biosimilar,

Shots: The US FDA has approved Nyvepria (pegfilgrastim-apgf) to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer therapies associated with a clinically significant incidence of febrile neutropenia The approval is based on the comprehensive data package and totality of evidence demonstrating a high bio similarity […]Read More

Fresenius Kabi Reports the US FDA’s Acceptance of BLA for

Shots: The BLA submission is based on analytical, PK/ PD, safety and immunogenicity data from two clinical studies that demonstrated equivalent PK/ PD profile to Neulasta, similar immunogenicity & comparable safety profile in healthy volunteers The BLA represents Fresenius Kabi’s first biosimilar candidate submitted to the FDA. Additionally, Fresenius Kabi also received EMA’s acceptance for […]Read More

Fresenius Kabi Reports EMA’s Acceptance of MAA for its MSB11455

Shots: The MAA submission of the MSB11455 includes the results of two pivotal clinical trials including bioequivalent PK & PD data with similar immunogenicity results and includes analytical plus safety data which was comparable to pegfilgrastim Fresenius Kabi’s attempt to submit MAA is another milestone following last year’s approval and launch of the company’s adalimumab […]Read More

Biocon and Mylan Launch Fulphila (biosimilar, pegfilgrastim) in Canada

Shots: The companies have launched Fulphila, a biosimilar referencing Neulasta (pegfilgrastim) and is approved by Health Canada to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-neoplastic drugs The approval is based on analytical, non/clinical data, which showed that Fulphila is highly similar to Neulasta with […]Read More

Biocon and Mylan Launch Fulphila (biosimilar, Pegfilgrastim) in Australia

Shots: The companies launched Fulphila, a biosimilar referencing Neulasta (pegfilgrastim) in Australia. The biosimilar received TGA’s approval to treat cancer patients following the CT, to decrease the duration of neutropenia and to reduce the incidence of infections, as manifested by febrile neutropenia The approval is based on analytical, clinical and nonclinical data which demonstrated that […]Read More

Biocon Report the US FDA’s Approval of sBLA for Fulphila

Shots: The approval of the new manufacturing facility for Fulphila (biosimilar, pegfilgrastim) allows Biocon and Mylan to expand their scale-up capacity, enabling greater patients to access globally. The US FDA had conducted a pre-approval inspection of the new manufacturing facility from Sep 10-19, 2019 Biocon is investing in building global-scale, cost-competitive, complex manufacturing facilities addressing […]Read More

Sandoz’s Ziextenzo (biosimilar, pegfilgrastim) Receives the US FDA’s Approval to

Shots: The FDA’s approval is based on three-way PK/PD study (LA-EP06-104) assessing Sandoz pegfilgrastim vs US-sourced reference pegfilgrastim, Sandoz pegfilgrastim vs EU-sourced reference pegfilgrastim, and US-sourced vs EU-sourced reference pegfilgrastim demonstrating no differences regarding safety and immunogenicity The addition of long-acting supportive oncology biosimilar will expand Sandoz’s oncology portfolio. Following the approval, Sandoz is the […]Read More

Mundipharma’s Pegfilgrastim Mundipharma (biosimilar, pegfilgrastim) Receives CHMP Positive Opinion for

Shots: The Mundipharma biosimilar Pegfilgrastim Mundipharma (6mg solution injection) will be authorized for sales in the EU to reduce the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy In Nov’2018, Mundipharma has received EC’s approval with trade name Pelmeg having same indication & same dose, which also […]Read More