Neugranin (balugrastim) / Teva - LARVOL DELTA

Advances in the pharmacological management of neutropenia in solid tumors: the advent of biosimilars. (PubMed, Expert Opin Pharmacother) - "Recently, several biosimilars have been developed. The market for biosimilar agents seems to be increasing over time thanks to their similar effectiveness and safety, compared with their originators, but lower costs."

Journal • Hematological Disorders • Neutropenia • Oncology • Solid Tumor

Efficacy and tolerability of granulocyte colony-stimulating factors in cancer patients after chemotherapy: A systematic review and Bayesian network meta-analysis. (PubMed, Sci Rep) - "S-G-CSF biosimilar, empegfilgrastim, and long-acting G-CSF (L-G-CSF) biosimilar were best G-CSF drugs in reducing severe neutropenia (SN) (cumulative probabilities: 21%, 20%, 15%, respectively). Mecapegfilgrastim, balugrastim, lipegfilgrastim and L-G-CSF biosimilar were best G-CSF drugs in reducing BP (cumulative probabilities: 20%, 14%, 8%, 8%, respectively). Mecapegfilgrastim, lipegfilgrastim and balugrastim might be the most appreciate G-CSF drugs with both good efficacy and tolerability when treating cancer patients after cytotoxic chemotherapy."

Journal • Retrospective data • Review • Hematological Disorders • Musculoskeletal Pain • Neutropenia • Oncology • Pain

Teva announces updates to oncology biologic portfolio (Teva Press Release) - “Teva launched LONQUEX® (long-acting G-CSF) in Germany on November 4, 2013…Teva launched GRANIX™ (short-acting G-CSF) in the U.S. on November 11, 2013...Last week, the company withdrew its balugrastim Biologics License Application (BLA) from the FDA review process following ongoing consultation with the agency in preparation for the late cycle review meeting, pending the provision of additional confirmatory data.”

Biosimilar launch • FDA event • Biosimilar

Efficacy and safety of balugrastim compared with pegfilgrastim in patients with breast cancer receiving chemotherapy (Clin Breast Cancer) - P3, N=304; NCT01126190; Sponsor: Teva; “The mean DSN in cycle 1 was 1.1 days in the balugrastim group and 1.0 days in the pegfilgrastim group (95% confidence interval [CI], -0.13-0.37)…Twenty percent of patients in the balugrastim group and 19% in the pegfilgrastim group had adverse events (AEs) considered to be related to study medication; 3.9% and 4.7% of patients, respectively, experienced serious AEs.”

P3 data • Biosimilar

Pharmacodynamics, pharmacokinetics, efficacy and safety of balugrastim in pediatric patients with solid tumors (clinicaltrials.gov) - P2, N=36; Sponsor: Teva; Not yet recruiting; New P2 trial.

New P2 trial • Biosimilar

Teva: Q3 2014 Results (Teva) - “…development of balugrastim… for the U.S. and the EU markets, will be terminated by the end of 2014”

Anticipated discontinuation • Biosimilar

CHMP summary of positive opinion for Egranli (European Medicines Agency) - “…the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Egranli, 40 mg, solution for injection intended for prophylaxis against chemotherapy-induced neutropenia…The active substance of Egranli is balugrastim, an immunostimulating medicinal product (L03AA15) which regulates the production and release of functional neutrophils from the bone marrow.”

European regulatory • Biosimilar

Biosimilar battle emerges as Teva cues up Neupogen rival (Vantage) - Anticipated Granix launch by end of 2013; "FDA still is reviewing the application for the long-acting albumin-fusion filgrastim called balugrastim…A 2014 launch has been mooted by Teva, but the lack of sales forecasts attached to the product suggests that its arrival date is still hard to call.”

Anticipated launch

Memory Function Is Associated with Tau Pathology in Parkinson’s Disease (AAIC 2019) - "Tau pathology reflects memory impairment, and the t-Tau/Aß1-42 ratio independently supports the diagnosis of cognitive impairment in PD."