Neupeg (pegfilgrastim biosimilar) / Intas, Apotex - LARVOL DELTA

PELGRAZ: Patient Preference Between a Prefilled Syringe or a Prefilled Pen Device for Administration of Pegfilgrastim (clinicaltrials.gov) - P=N/A | N=150 | Completed | Sponsor: Institut Rafael | Active, not recruiting ➔ Completed

Trial completion • Febrile Neutropenia • Hematological Disorders • Neutropenia

Lapelga vs Gastrofil (clinicaltrials.gov) - P3 | N=74 | Not yet recruiting | Sponsor: Lawson Health Research Institute

New P3 trial • Bone Marrow Transplantation • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Lymphoma • Multiple Myeloma • Neutropenia • Oncology • Transplantation • CD34

PELGRAZ: Patient Preference Between a Prefilled Syringe or a Prefilled Pen Device for Administration of Pegfilgrastim (clinicaltrials.gov) - P=N/A | N=150 | Active, not recruiting | Sponsor: Institut Rafael | Recruiting ➔ Active, not recruiting | Trial primary completion date: Jun 2024 ➔ Sep 2023

Enrollment closed • Trial primary completion date • Febrile Neutropenia • Hematological Disorders • Neutropenia • Solid Tumor

PELGRAZ: Patient Preference Between a Prefilled Syringe or a Prefilled Pen Device for Administration of Pegfilgrastim (clinicaltrials.gov) - P=N/A | N=150 | Recruiting | Sponsor: Institut Rafael

New trial • Febrile Neutropenia • Hematological Disorders • Neutropenia • Solid Tumor

Primary Prophylaxis Lapelga in Early Breast Cancer: A Real-World Experience. (PubMed, Curr Oncol) - "In this single centre retrospective study, early breast cancer patients (n = 201) treated with adjuvant chemotherapy supported with primary prophylaxis with Lapelga had a low incidence of FN (3.48%). This supports Lapelga being an effective strategy as the primary prophylaxis when used with common chemotherapy regimens in the real-world setting."

Journal • Real-world • Real-world evidence • Retrospective data • Breast Cancer • Febrile Neutropenia • Hematological Disorders • Musculoskeletal Diseases • Musculoskeletal Pain • Neutropenia • Oncology • Pain • Solid Tumor

A RETROSPECTIVE REVIEW OF THE REAL-WORLD EXPERIENCE OF THE PEGFILGRASTIM BIOSIMILAR (LAPELGA®) TO THE REFERENCE BIOLOGIC (NEULASTA®) (MASCC-ISOO 2022) - "Conclusions The results suggest that Lapelga® is non-inferior to its reference biologic Neulasta®. There were also no clinically meaningful differences in efficacy or safety between the two treatments"

Real-world evidence • Retrospective data • Review • Breast Cancer • Febrile Neutropenia • Hematological Disorders • Neutropenia • Oncology • Solid Tumor

A comparative multi-tiered immunogenicity assessment of biosimilar pegylated filgrastim: validation of methods for clinical assessment of INTP5. (PubMed, Expert Opin Biol Ther) - "This work demonstrates the application of a rigorous approach toward validation of assays for immunogenicity studies for biosimilars. Highly sensitive, precise, and robust assays were used to conclude comparable low incidences of anti-drug antibodies in both biosimilar and innovator arms of the clinical study for Pegfilgrastim."

Clinical • Journal

District court denies Apotex’s motion to dismiss Amgen’s complaint in second lawsuit (Big Molecule Watch) - "...the district court in Amgen v. Apotex (No. 18-61828) (S.D. Fla.) denied Apotex’s motion to dismiss Amgen’s complaint in a follow-on suit concerning Apotex’s pegfilgrastim and filgrastim biosimilar candidates."

Corporate lawsuit • Neutropenia

PTAB institutes PGR of protein refolding patent at issue in filgrastim and pegfilgrastim litigations (Big Molecule Watch) - "This past Friday, April 19, 2019, the PTAB granted Adello and Amgen’s petition, instituting a PGR of all 30 claims of the ’287 patent on multiple alleged grounds of unpatentability including lack of adequate written description support (claims 1–9 and 16–25), lack of enablement (same), indefiniteness (claims 1–15), anticipation (claims 1–4, 7–19, and 22–30), and obviousness (all claims). The PTAB also issued a scheduling order, calling for oral argument (if requested) on January 29, 2020."

Patent

Single-Dose Pharmacokinetics, Pharmacodynamics and Immunogenicity, and Multiple-Dose Immunogenicity of INTP5 (Pegfilgrastim Biosimilar) Versus Reference Pegfilgrastim in Healthy Subjects. (PubMed, Clin Drug Investig) - "INTP5 showed PK/PD equivalence with pegfilgrastim-ref following a single dose, no clinically meaningful difference in the immune response following multiple doses, and a comparable safety profile."

Clinical • Journal • PK/PD data • Musculoskeletal Diseases • Musculoskeletal Pain • Pain

A retrospective review of the real-world experience of the Pegfilgrastim biosimilar (Lapelga®) to the reference biologic (Neulasta®). (PubMed, J Oncol Pharm Pract) - "The biosimilar pegfilgrastim was non-inferior to the reference biologic based on FN incidence in addition to related outcomes including DR and DD."

Journal • Real-World Evidence • Retrospective data • Breast Cancer • Hematological Disorders • Neutropenia • Oncology • Pain • Solid Tumor

Accord-UK launches Pelgraz injector and app (PharmaTimes) - "Accord UK says its Pelgraz Pre-filled Injector (PFI; pegfilgrastim) is now available for cancer patients in the UK, enabling them to self-inject at home and thus reduce trips to hospital....Pelgraz PFI is indicated to reduce the duration of neutropenia and the incidence of febrile neutropenia in adults undergoing cytotoxic chemotherapy."

Commercial • Neutropenia • Oncology

Accord-UK launches Pelgraz (pegfilgrastim) Pre-filled Injector and patient app, supporting patients to self-inject at home (PRNewswire.co.uk) - "Pelgraz® PFI is a long-acting supportive therapy indicated to reduce the duration of neutropenia and the incidence of febrile neutropenia in adult patients undergoing cytotoxic chemotherapy, and provides patients with the convenience of a one dose per chemotherapy cycle regime in a device that enables patients to self-administer the injection at home. To further support cancer patients prescribed Pelgraz® PFI, Accord have developed an app with features to remind patients when and how to administer their injection, support with tracking any side effects and symptoms experienced during active treatment, and information on pegfilgrastim and neutropenia to help increase patients' understanding of their treatment."

Biosimilar launch • General devices event • Neutropenia

[VIRTUAL] Proof: pegfilgrastim biosimilar - patient population and day of use (DGHO 2020) - "We report first results from PROOF, a non-interventional study evaluating treatment patterns of the biosimilar PegF Pelgraz®... Interim data confirm that PegF is generally given as prophylaxis to pts with medium to high FN risk, and thus in accordance with international guidelines. FN rates were low, in line with other published data. Future analysis is necessary to elucidate the efficacy of PegF in more complex CT, particularly with regard to the day of administration."

Clinical • Hematological Disorders • Lung Cancer • Neutropenia • Oncology • Solid Tumor

[VIRTUAL] Proof: pegfilgrastim biosimilar - patient population and day of use (DGHO 2020) - "We report first results from PROOF, a non-interventional study evaluating treatment patterns of the biosimilar PegF Pelgraz®... Interim data confirm that PegF is generally given as prophylaxis to pts with medium to high FN risk, and thus in accordance with international guidelines. FN rates were low, in line with other published data. Future analysis is necessary to elucidate the efficacy of PegF in more complex CT, particularly with regard to the day of administration."

Clinical • Hematological Disorders • Lung Cancer • Neutropenia • Oncology • Solid Tumor

[VIRTUAL] Proof: pegfilgrastim biosimilar - patient population and day of use (DGHO 2020) - "We report first results from PROOF, a non-interventional study evaluating treatment patterns of the biosimilar PegF Pelgraz®... Interim data confirm that PegF is generally given as prophylaxis to pts with medium to high FN risk, and thus in accordance with international guidelines. FN rates were low, in line with other published data. Future analysis is necessary to elucidate the efficacy of PegF in more complex CT, particularly with regard to the day of administration."

Clinical • Hematological Disorders • Lung Cancer • Neutropenia • Oncology • Solid Tumor

[Poster coverage] Microarray data analysis and long term outcomes of NCIC-CTG MA.22: Neoadjuvant epirubicin and docetaxel with pegfilgrastim support for locally advanced breast cancer (SABCS-2013) - Abstract #P3-14-11; P1/2, N=93; “Median overall survival was 6.34 years on study. DFS at 50 months was 55% for A (phase 2) and 67% for B (phase 2), while EFS was 55% for A and 63% for B. For ER or PR+ DFS and EFS were 60% and for ER- PR- DFS and EFS were 63%. 134 arrays were available in total: 57 from A, 68 from B with 11 reference breast tumour RNAs for standardization. Patients with and without microarrays were not significantly different.”

P1/2 data • Biosimilar • Breast Cancer

FDA likely to require substantial clinical data for interchangeable biosimilars, lawyers say (Regulatory Focus) - "The...FDA) is “almost certain” to require clinical data in order for companies to demonstrate interchangeability between a biosimilar and its reference product...six biosimilar applications are currently pending FDA review: Celltrion’s biosimilar of infliximab...to treat autoimmune disorders such as rheumatoid arthritis...A future date has yet to be announced. Two biosimilar applications relating to Amgen’s Neulasta (pegfilgrastim) from Apotex and Sandoz; Apotex’s biosimilar based on Amgen’s Neupogen...Sandoz’s 262(k) application for a biosimilar version of etanercept, which is based on Amgen’s Enbrel; And Amgen’s 262(k) application based on its own reference product Humira (adalimumab)."

Anticipated FDA event • Biosimilar • Rheumatoid Arthritis

Apotex announces FDA has accepted for filing its biosimilar application for pegfilgrastim (PRNewswire) - “Apotex…announced today that the US Food and Drug Administration has accepted for filing the company's application for pegfilgrastim, a biosimilar version of Amgen's Neulasta®. The product has been jointly developed with Intas Pharmaceuticals Ltd…The product will be marketed in the United States by ApoBiologix®, a division of Apotex Corp.”

BLA • Biosimilar

Accord’s Pelgraz approved for use during chemotherapy (Pharmafield) - "The European Medicines Agency (EMA) has approved Accord’s Pelgraz (pegfilgrastim), pegylated granulocyte-colony stimulating factor (G-CSF) biosimilar in Europe. Pelgraz is indicated to reduce the duration of neutropenia and the incidence of febrile neutropenia for adult patients undergoing cytotoxic chemotherapy."

European regulatory

Accord Healthcare’s (Intas) Pelgraz (pegfilgrastim) given green light by CHMP (PRNewswire.co.uk) - "The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Accord's Pelgraz (pegfilgrastim), pegylated granulocyte-colony stimulating factor (G-CSF) biosimilar in Europe. Once approved, Pelgraz could be the first pegfilgrastim biosimilar to market in Europe indicated to reduce the duration of neutropenia and the incidence of febrile neutropenia for adult patients undergoing cytotoxic chemotherapy."

European regulatory • Hematological Disorders • Neutropenia

Pegfilgrastim biosimilar Lapelga approved in Canada (GaBI) - "Canada-based Apotex received approval for its pegfilgrastim biosimilar, Lapelga, from Health Canada with positive decision made on 5 April 2018. This marks the first pegfilgrastim biosimilar to be approved by the Canadian medicines regulator....The positive decision was issued as the similarity of Lapelga to Neulasta has been established based on comparative analytical and functional, non-clinical, PK/PD and clinical studies, and clinically meaningful differences in safety and immunogenicity between Lapelga and Neulasta were observed."

Canadian regulatory • Biosimilar

"Apotex Mystery: Why Has Accord BioPharma Taken Its Place In Pegfilgrastim Biosimilar Litigation? https://t.co/Joq3LbSCdV #PinkSheet" (@PharmaPinkSheet)

Pharmacokinetic and pharmacodynamic bioequivalence study of a pegfilgrastim biosimilar INTP5 in healthy subjects. (PubMed, Cancer Chemother Pharmacol) - "Pharmacokinetic and pharmacodynamic bioequivalence was established between INTP5 and Neulasta following 3 and 6 mg doses. Safety and immunogenicity profiles were similar between INTP5 and Neulasta."

Clinical • Journal • PK/PD data

Comparative Immunogenicity Study of Multiple Doses of Proposed Pegfilgrastim Biosimilar, INTP5 of Intas Pharmaceuticals Ltd., India Against Neulasta of Amgen Inc., USA in Healthy, Adult Human Subjects. (clinicaltrials.gov) - P1; N=200; Completed; Sponsor: Intas Pharmaceuticals, Ltd.

Clinical • New P1 trial