Neukine (filgrastim biosimilar) / Intas, Apotex - LARVOL DELTA

"Anemia may be pre-existing ma'am. IF by ELISA/ Anti Parietal cell abs may help determine whether it's a preexisting pernicious. If cytopenias are worsening, NEUKINE may help." (@DrMGHegde)

Anemia • Hematological Disorders

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

A study of Pegfilgrastim PFS in Paediatric Patients Under 6 years of Age with Rhabdomyosarcoma or Wilms’ Tumour on Myelosuppressive Chemotherapy (CmT) Regimen. (clinicaltrialsregister.eu) - P3; N=12; Sponsor: Intas Pharmaceuticals Ltd.

Clinical • New P3 trial • Oncology • Pediatrics • Rhabdomyosarcoma • Sarcoma • Solid Tumor • Wilms Tumor

Assessing analytical comparability of biosimilars: GCSF as a case study (ACS-Sp 2017) - "In the present work, we use such an analytical platform for assessing comparability of five approved Granulocyte Colony Stimulating Factor (GCSF) biosimilars (Emgrast, Lupifil, Colstim, Neukine and Grafeel) to the innovator product, Neupogen®. For the most part, the biosimilar drugs were found to be comparable to the innovator drug anomaly that was identified was that three of the biosimilars had a typical variant which was reported as an oxidized species in the literature. But, upon further investigation using RPC-FLD and ESI-MS we found that this is likely a conformational variant of the biotherapeutic been studied."

Biosimilar

Assessing analytical comparability of biosimilars: GCSF as a case study. (PubMed) - J Chromatogr B Analyt Technol Biomed Life Sci - "For the most part, the biosimilar drugs were found to be comparable to the innovator drug anomaly that was identified was that three of the biosimilars had a typical variant which was reported as an oxidized species in the literature. But, upon further investigation using RPC-FLD and ESI-MS we found that this is likely a conformational variant of the biotherapeutic been studied."

Journal • Biosimilar