Current Issue : January - March Volume : 2015 Issue Number : 1 Articles : 5 Articles
Using site-direct mutagenesis and recombinant DNA technology, we had previously obtained a structurally modified derivative of human G-CSF termed G-CSFa. G-CSFa contains alanine 17 (instead of cysteine 17 as in wildtype G-CSF) as well as four additional amino acids (methionine, arginine, glycine and serine) at the amino terminus. Previous studies showed that G-CSFa is more potent than the wild-type counterpart in stimulating proliferation and differentiation of myeloid cells of the granulocytic lineage, both in vitro and in vivo. Here, we show that G-CSFa can significantly accelerate peripheral platelet recovery in C57BL/6 mice exposed to radiotherapy. We further demonstrate that G-CSFa is not immunogenic in rats, by confirming the absence of any binding antibodies, analyzed using ELISA, or neutralizing antibodies, determined using the NFS-60 cell proliferation bioassay, to G-CSFa in the sera of Sprague-Dawley rats following repeated G-CSFa administration. Taken together, these findings further support the benefits of G-CSFa for clinical therapy....
Biologics such as rituximab are an important component of oncology treatment\nstrategies, although access to such therapies is challenging in countries with limited\nresources. This study examined access to rituximab and identified potential barriers to its\nuse in the United States, Mexico, Turkey, Russia, and Brazil. The study also examined\nwhether availability of a biosimilar to rituximab would improve access to, and use of,\nrituximab. Overall, 450 hematologists and oncologists completed a survey examining their\nuse of rituximab in patients with non-Hodgkin�s lymphoma (NHL) and chronic lymphocytic\nleukemia (CLL). Less than 40% of physicians considered rituximab as easy to access from\na cost perspective. Furthermore, many physicians chose not to treat, were unable to treat, or\nhad to modify treatment with rituximab despite guidelines recommending its use in NHL\nand CLL patients. Insurance coverage, reimbursement, and cost to patient were commonly\nreported as barriers to the use of rituximab. Across all markets, over half of physicians\nreported that they would increase use of rituximab if a biosimilar was available.\nWe conclude that rituximab use would increase across all therapy types and markets if a\nbiosimilar was available, although a biosimilar would have the greatest impact in Brazil,\nMexico, and Russia....
Trastuzumab in combination with chemotherapy has become a standard of care\nfor patients with HER2+ breast cancer. The cost of therapy, however, can limit patient access\nto trastuzumab in areas with limited financial resources for treatment reimbursement. This\nstudy examined access to trastuzumab and identified potential barriers to its use in the United\nStates, Mexico, Turkey, Russia and Brazil via physician survey. The study also investigated\nif the availability of a biosimilar to trastuzumab would improve access to and use of HER2\nmonoclonal antibody therapy. Across all countries, a subset of oncologists reported barriers\nto the use of trastuzumab in a neoadjuvant, adjuvant or metastatic setting. Common barriers\nto the use of trastuzumab included issues related to insurance coverage, drug availability and\ncost to the patient. Overall, nearly half of oncologists reported that they would increase the\nuse of HER2 monoclonal antibody therapy across all treatment settings if a lower cost\nbiosimilar to trastuzumab were available. We conclude that the introduction of a biosimilar\nto trastuzumab may alleviate cost-related barriers to treatment and could increase patient\naccess to HER2-directed therapy in all countries examined...
Background: The approval of epoetin biosimilars in the European Union requires extensive scientific evaluation\nand stringent regulatory procedures, including post-marketing studies. The ORHEO (place of biOsimilaRs in the\ntherapeutic management of anaemia secondary to chemotherapy in HaEmatology and Oncology) study was an\nobservational, longitudinal, multicentre study performed in France to evaluate the efficacy and safety of biosimilar\nepoetins for the treatment of chemotherapy-induced anaemia (CIA) in the clinical setting.\nMethods: Patients >18 years with CIA (haemoglobin [Hb] <11 g/dL) in association with solid tumours, lymphoma or\nmyeloma and eligible for treatment with an epoetin biosimilar were included in this study. Patient characteristics were\nrecorded at baseline along with anaemia-related information, such as observed and target Hb (as chosen by the\ntreating clinician), brand and dose of epoetin biosimilar prescribed, and details of any other treatments. Patients were\nthen followed-up at 3 and 6 months. The primary endpoint was Hb response (defined as Hb reaching ?10 g/dL, an\nincrease of Hb ?1 g/dL since inclusion visit or reaching physician-defined target Hb, with no blood transfusions in the\n3 weeks prior to measurement). Other endpoints included adverse events, achievement of target Hb and associated\ntreatments.\nResults: Overall, 2333 patients >18 years (mean age 66.5 years) with CIA (haemoglobin [Hb] <11 g/dL) in association\nwith solid tumours, lymphoma or myeloma and eligible for biosimilar epoetin treatment were included. 99.9% of\npatients received epoetin zeta (median dose 30,000 IU/week). Mean baseline Hb was 9.61 g/dL, with 35.6% of patients\nhaving moderate anaemia (Hb 8ââ?¬â??9.5 g/dL). Hb response was achieved in 81.6% and 86.5% of patients at 3 and\n6 months, respectively. Overall mean change in Hb level was 1.52 Ã?± 1.61 and 1.72 Ã?± 1.61 g/dL at 3 and 6 months,\nrespectively. Transfusion and thromboembolic event rates were 9.4% and 2.4% at 3 months, and 5.8% and 1.5% at\n6 months, respectively.\nConclusions: Epoetin zeta was effective and well tolerated in the management of CIA in patients with solid tumours,\nlymphoma and myeloma....
Therapeutic proteins are next-generation drugs in the prevention and treatment of diseases, in particular human critical illness. The expiration of patents in the originally approved biopharmaceutics has stimulated a great excitement and the subsequent development of ââ?¬Å?follow-onââ?¬Â versions of these first-in-line biotherapeutic products, known as ââ?¬Å?Biosimilarsââ?¬Â or ââ?¬Å?Biobettersââ?¬Â. Biosimilars are a new class of drugs intended to offer comparable safety and efficacy (or clinical equivalence) to their original reference products which are brand name drugs and no longer under patent coverage. However, preparing exact copies of biologicals is much more challenging than replicating small molecules due to their structural complexity, intricate manufacturing processes and their potential risks for increased immunogenicity. Therefore, specific regulatory approval pathways and guidelines must be followed when creating Biosimilars. This article reviews the requirements and key considerations for producing Biosimilar agents as well as the important Biosimilar guidelines/regulations from different countries including the World Health Organization, Food and Drug Administration and the European Medicines Agency.\n\nConclusion\n\nPatents that expired or are soon to expire have provided a great opportunity for companies to make copies or ââ?¬Ë?genericââ?¬â?¢ versions of these drugs. Despite some challenges, therapeutic development of lower cost Biosimilars will inevitably enter the drug market in the near future, increasing the market competition and patients' access to the more cost-effective therapies that they may not have otherwise....
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