Pelmeg (pegfilgrastim biosimilar) / Mundipharma - LARVOL DELTA

Pharmacokinetic and pharmacodynamic comparability of B12019: A proposed pegfilgrastim biosimilar (ESMO 2017) - P1; "· The clinical program confirmed the biosimilarity of B12019 and Neulasta in highly sensitive clinical study settings. · PK comparability of B12019 and Neulasta was demonstrated at the clinical dose of 6 mg. · PD comparability of B12019 and Neulasta was shown at the clinical dose of 6 mg and the reduced dose of 3 mg."

Oncology

Pharmacokinetics, pharmacodynamics, safety, and immunogenicity of Pelmeg, a pegfilgrastim biosimilar in healthy subjects. (PubMed, Pharmacol Res Perspect) - "No clinically meaningful differences were observed for safety and immunogenicity between Pelmeg and Neulasta. Pelmeg was found to be highly similar to the reference product."

Clinical • Journal • PK/PD data • Hematological Disorders • Neutropenia

Pharmacodynamics, safety, and immunogenicity of Pelmeg, a pegfilgrastim biosimilar in healthy subjects. (PubMed, Pharmacol Res Perspect) - "No clinically meaningful differences in safety between Pelmeg and Neulasta were observed. Overall, the results from this study confirmed the biosimilarity of Pelmeg and Neulasta for PD and immunogenicity, as shown already at the bioanalytical level and in the pivotal PK/PD study with Pelmeg."

Clinical • Journal • PK/PD data • Hematological Disorders

Cinfa Biotech publishes clinical data abstract at the 58th American Society of Hematology (ASH) annual meeting 2016 (Cinfa Biotech Press Release) - P1, N=172; NCT02629562; Sponsor: Cinfa Biotech; "Cinfa...today announced that an abstract has been published at the 58th Annual Meeting of the American Society of Hematology...Abstract publication number 5079 titled: 'Demonstration of Pharmacokinetic and Pharmacodynamic Equivalence in Healthy Volunteers for B12019, a New Proposed Pegfilgrastim Biosimilar'...The study met all of its primary endpoints for pharmacokinetics (PK): Area Under the Curve for concentration (AUC0-last) and Cmax; plus pharmacodynamics (PD): Absolute Neutrophil Count (ANC) and Area Under the Effect Curve (AUEC)...A poster presentation with full data from the trial will be delivered at the European Cancer Congress (ECCO) in Amsterdam, on 29 January 2017."

Anticipated conference • PK/PD data • Biosimilar

B12019: "There was no relevant difference in the exposure of pegfilgrastim after administration of B12019 and Neulasta… (Cinfa Biotech) - ECCO 2017: "There was no relevant difference in the exposure of pegfilgrastim after administration of B12019 and Neulasta®. Geometric mean ratios were 95.23 % for AUC_0-last and 92.84 % for C_max and the corresponding 94.32 % confidence intervals were both fully included within the range of 80.00 % to 125.00 %"; "There was no relevant difference in ANC after administration of B12019 and Neulasta®. Geometric mean ratio of AUEC_0-last was 100.20 % and the corresponding 95.00 % confidence interval was very close to 100.00 % (98.67 %; 101.75 %)"

P1 data • Biosimilar

B12019: "Drug-related TEAEs reported in ≥5% of subjects in any group, by SOC and PT, across all periods" (Cinfa Biotech) - ASH 2017: "The safety and immunogenicity profile of B12019 after single and repeat dosing did not show any clinically meaningful differences to Neulasta"

P1 data • Biosimilar

EMA to review Cinfa Biotech's pegfilgrastim biosimilar (Center for Biosimilars) - "Cinfa Biotech has announced that the European Medicines Agency (EMA) has accepted for review the company’s marketing authorization application for biosimilar pegfilgrastim."

European regulatory • Biosimilar

Cinfa Biotech: ASH 2016 (Cinfa Biotech) - Anticipated full data from P1 (NCT02629562) trial in chemotherapy-induced neutropenia at ECCO (on Jan 29, 2017)

Anticipated P1 data • Biosimilar

European Commission approves Pelmeg (pegfilgrastim) as a biosimilar treatment to reduce the duration of neutropenia and incidence of febrile neutropenia in adults treated with chemotherapy (Businesswire) - "The Mundipharma network of independent associated companies today announced that the European Commission (EC) has granted approval for the use of Pelmeg (pegfilgrastim) as a treatment for reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes)."

European regulatory • Hematological Disorders • Neutropenia

B12019: "There was no relevant difference in the exposure of pegfilgrastim after administration of 6 mg B12019 and Neulasta®" (Cinfa Biotech) - ESMO 2017: "There was no relevant difference in ANC after B12019 or Neulasta® administration of 6 mg (B12019-101) and 3 mg (B12019-102)"

P1 data • Biosimilar

Mundipharma receives positive CHMP opinion for pegfilgrastim biosimilar (Center for Biosimilars) - "...the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion of Mundipharma’s pegfilgrastim biosimilar."

European regulatory

Pair of studies on Pelmeg confirm its biosimilarity to reference pegfilgrastim (Center for Biosimilars) - "According to the authors, these results, taken together with the findings from the first study, confirm the biosimilarity of Pelmeg with the EU-authorized Neulasta."

Clinical

Eye on Pharma: Egis to distribute Mundipharma's Pelmeg in Eastern Europe (Center for Biosimilars) - "Mundipharma, a network of independent companies that operates in 120 countries worldwide and distributes a number of biosimilars in the European Union, has inked a deal with Budapest-based Egis Pharmaceuticals to distribute its biosimilar pegfilgrastim, Pelmeg, in 4 Eastern European markets: Hungary, Romania, Lithuania, and Latvia."

Licensing / partnership

Pelmeg (EMEA) - "...the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Pelmeg, intended to reduce the duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy."

European regulatory

Napp launches Pelmeg a biosimilar of pegfilgrastim in the UK (Pharmafield) - "Napp Pharmaceuticals Limited has announced the launch of Pelmeg® a biosimilar of pegfilgrastim in the UK...Pelmeg® is indicated for the reduction in the duration of neutropenia and incidence of febrile neutropenia (FN) in adults treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes)."

Biosimilar launch

"#Mundipharma launches #Pelmeg®▼(#pegfilgrastim) biosimilar in Europe https://t.co/nYKiqSKUEX" (@1stOncology)

Biosimilar launch • Launch Europe

Mundipharma launches Pelmeg (pegfilgrastim) biosimilar in Europe (Businesswire) - "The Mundipharma...announced the launch of Pelmeg® (pegfilgrastim), a biosimilar of Neulasta® following European Commission (EC) approval in November 2018....Now available in Germany, the Netherlands and Ireland, Pelmeg is indicated for the reduction of the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes)."

Biosimilar launch