Meta-analysis of Pharmacokinetic/Pharmacodynamic Results of 3 Phase 1 Studies with Biosimilar Pegfilgrastim.

A meta-analysis using data from 3 phase 1 studies evaluated the pharmacokinetics (PK) and pharmacodynamics (PD) of Sandoz biosimilar versus US- and EU-reference pegfilgrastim. The studies included a single-dose, double-blind, 3-arm, parallel-group study (study 1); a single-dose, double-blind, 2-way crossover study (study 2); and a single-dose, double-blind, 3-way, 6-sequence crossover study (study 3). Healthy male and female subjects were randomized to receive the proposed biosimilar (all studies), US-reference biologic (studies 1 and 3), or EU-reference biologic (studies 1, 2, and 3).

Real-world perspective on career of pharmaceutical physicians in India: A working report (2018).

Background: Pharmaceutical physicians support drug development in various capacities and contribute tremendously to the healthcare system. However, there is lack of substantial information on career progression of pharmaceutical physicians in India.

Materials And Methods: This cross-sectional survey involved distribution of a questionnaire via internet, to be self-administered and returned electronically from March 1, 2018, to May 31, 2018 (3 months).

Career Planning for Physicians Within the Pharmaceutical Industry.

Transitioning into 'pharma' is a challenging career decision since it is very different from working in individual patient care. However, for many, the opportunity to develop innovative medicines, communicate their benefits, and, thus, influence the care of thousands of patients at a time is a rewarding alternative. The current paper explores the "Why-What-How" of successful physician careers within the pharmaceutical industry, realizing both professional and philosophical perspectives.

Critical Factors Shaping Strategy Development of an Innovative Medicine in Oncology.

Innovative medicinal products are required to achieve progress in oncology; however, these are associated with high financial investments, extensive development times, and significant risk of potential failure in the pivotal clinical trials required for marketing authorization. With increasing budgetary constraints and requirements to demonstrate value, effective strategies to develop and commercialize innovative oncology products are more important than ever. Strategies that have proved successful in other industries require major revision for use in the oncology field, both during preclinical and clinical development as well as in the post approval value chain.

A large multicentre, randomized, double-blind, cross-over study in healthy volunteers to compare pharmacokinetics, pharmacodynamics and safety of a pegfilgrastim biosimilar with its US- and EU-reference biologics.

Aims: Recombinant PEGylated human granulocyte colony-stimulating factor (pegfilgrastim) is indicated for the reduction of chemotherapy-induced neutropenia and prevention of febrile neutropenia. Biosimilar pegfilgrastim is expected to reduce the financial burden of this complication of chemotherapy. The aim of this study was to demonstrate biosimilarity between Sandoz biosimilar pegfilgrastim and its US- and EU-approved reference biologics.

Safety analysis of proposed pegfilgrastim biosimilar in Phase I and Phase III studies.

This analysis compares safety data for Sandoz proposed biosimilar (LA-EP2006) and reference pegfilgrastim from a Phase I pharmacokinetic/pharmacodynamic study in healthy volunteers (HVs) and two Phase III confirmatory studies in patients with breast cancer (BC; total n = 808). Baseline characteristics were summarized, and event rates of bone pain and headache calculated. HVs in the Phase I pharmacokinetic/pharmacodynamic study were generally younger, with lower mean body mass index, versus BC patients in PROTECT-1/-2.

Proposed biosimilar pegfilgrastim shows similarity in pharmacokinetics and pharmacodynamics to reference pegfilgrastim in healthy subjects.

Aims: This study aimed to demonstrate that the pharmacokinetic (PK) and pharmacodynamic (PD) profile of Sandoz proposed biosimilar pegfilgrastim (LA-EP2006) matches reference pegfilgrastim (Neulasta ) in healthy subjects. Safety and immunogenicity were also assessed.

Methods: The phase I, randomized, double-blind, two-period crossover study consisted of two treatment periods separated by an 8-week washout period.

Safety Profile of Biosimilar Filgrastim (Zarzio/Zarxio): A Combined Analysis of Phase III Studies.

Background: Evaluation of adverse events (AEs) in pivotal registration trials and ongoing postmarketing surveillance is important for all biologics, including biosimilars. A combined analysis of two pivotal registration studies was performed to strengthen evidence on safety for biosimilar filgrastim EP2006 in patients with breast cancer receiving myelosuppressive chemotherapy, a sensitive clinical setting to confirm biosimilarity of filgrastim.

Materials And Methods: Data were combined from two phase III studies of biosimilar filgrastim EP2006.

Healthy donor hematopoietic stem cell mobilization with biosimilar granulocyte-colony-stimulating factor: safety, efficacy, and graft performance.

Background: Biosimilar granulocyte-colony-stimulating factors (G-CSFs) have been available in the European Union since 2008, and Sandoz' biosimilar filgrastim was approved in the United States in March 2015 for all of the reference product's indications except acute radiation syndrome. Biosimilar G-CSFs have been largely embraced by the medical community, except for some reservations about healthy-donor stem cell mobilization, for which use outside of clinical studies was cautioned against by some members of the scientific community.

Study Design And Methods: In a two-center safety surveillance study (National Clinical Trial NCT01766934), 245 healthy volunteer stem cell donors were enrolled.