BACKGROUND Following the release of the initial presentation of filgrastim (granulocyte colony-stimulating factor), several biosimilars have been developed worldwide. OBJECTIVE To study the efficacy of a Mexican biosimilar granulocyte colony-stimulating factor in a single transplant center. METHODS In a group of 19 consecutive patients with multiple sclerosis given autografts, we employed g...

BACKGROUND The purpose of this paper is to report real-world data on the relative effectiveness of a biosimilar erythropoiesis-stimulating agent (ESA; Binocrit(®)), and other available ESAs for the treatment of chemotherapy-induced anemia. METHODS Data were collected retrospectively from single centers in Spain (n=284) and Germany (n=145). Hemoglobin outcomes, transfusion requirements, and se...

K E Y W O R D S Biosimilar, intact mass analysis, intact mass subunit analysis, light chain, heavy chain, glycosylation, glycoprofile, infliximab, mAb, biotherapeutic characterization A P P L I C AT IO N B E N E F I T S A streamlined workflow within an integrated UPLC-MS/MS system solution that features automated data acquisition, processing, and reporting, and that is deployable to both regula...

Biologics such as monoclonal antibodies and recombinant proteins represent a significant portion of the pharmaceutical market. With many of the first generation biologics' patents expiring, an increasing number of biosimilars will be submitted for approval in the near future. The successful development of a biosimilar requires the demonstration of biosimilarity in terms of efficacy, safety and ...

In a defining moment for the European Medicines Agency (EMA) and the biopharmaceutical industry, on June 27, 2013 EMA's Committee for Medicinal Products for Human Use adopted a positive opinion for two biosimilar infliximab products (Celltrion's Remsima® and Hospira's Inflectra®), and recommended that they be approved for marketing in the European Union (EU). The European Commission's decision ...

Biosimilar development involves a target-directed iterative process to ensure a similar product to the originator. Here we report the preclinical development of the proposed biosimilar rituximab (GP2013). Post-translational modifications and bioactivities of GP2013 versus originator rituximab were engineered and monitored to ensure similar pharmacological profiles. Antibody-dependent cellular c...

Biological medical products are drugs whose active components are produced only by living, genetically modified organisms or live cell cultures. Patents and exclusivity for most biopharmaceuticals has either expired or will expire soon, which enables biotechnological companies to introduce similar biological products. The problem of replacing a biological medicine with a biosimilar in the cours...

Biologics have become key agents for the management of Crohn's disease and ulcerative colitis. Biosimilars are biological medicines similar to previously authorized biologics and are already available in some countries. This ECCO Position Statement defines the collective view of European specialist in inflammatory bowel disease (IBD) concerning biosimilars. Biosimilars are not comparable to gen...

background: trastuzumab (herceptin) is a humanized monoclonal antibody (mab) which is used for specific treatment of metastatic breast cancer in patients with overexpression of her2/neu receptor. in this study, we have attempted to develop a biosimilar version of trastuzumab mab. methods: according to in silico studies, the heavy and light chains of trastuzumab mab were designed and constructed...