Current Issue : April - June Volume : 2018 Issue Number : 2 Articles : 5 Articles
Eptacog alfa (NovoSevenÃ?®) is a vitamin K-dependent recombinant Factor VIIa produced by\ngenetic engineering from baby hamster kidney (BHK) cells as a single peptide chain of 406 residues.\nAfter activation, it consists of a light chain (LC) of 152 amino and a heavy chain (HC) of 254 amino\nacids. Recombinant FVIIa undergoes many post-translational modifications (PTMs). The first ten\nglutamic acids of the N-terminal moiety are Ã?³-carboxylated, Asn145 and Asn322 are N-glycosylated,\nand Ser52 and Ser60 are O-glycosylated. A head-to-head biosimilarity study was conducted\nfor the originator and the first biosimilar AryoSevenââ??¢ to evaluate comparable bioengineering.\nPhysicochemical properties were analyzed based on mass spectrometry, including intact mass,\nPTMs and higher-order structure. Both biotherapeutics exhibit a batch-to-batch variability in their\nN-glycan profiles. N-Glycopeptide analysis with UHPLC-QTOF-MSE confirmed N-glycosylation\nsites as well as two different O-glycopeptide sites. Ser60 was found to be O-fucosylated and\nSer52 had O-glucose or O-glucose-(xylose)1,2 motifs as glycan variants. Ion mobility spectrometry\n(TWIMS) and NMR spectroscopy data affirm close similarity of the higher-order structure of\nboth biologicals. Potency of the biodrugs was analyzed by a coagulation assay demonstrating\ncomparable bioactivity. Consequently, careful process optimization led to a stable production process\nof the biopharmaceuticals....
Cancer is a major public health issue worldwide, especially in the developing\nworld where 70% of the cancer-related deaths occur. During the last three\ndecades, with the advent of targeted therapies using monoclonal antibodies,\npatients� survival and quality of life have dramatically improved. Unfortunately,\nthese great accomplishments came at the expense of high financial\ncosts which most of the population living in low-and middle-income countries\ncannot afford. Biosimilars (biotherapeutic products that are similar to an\nalready licensed reference biotherapeutic product in terms of quality, safety\nand efficacy) have been successfully used in Europe and in US with a substantial\nreduction in price of around 30%. Brazil is about to have trastuzumab as\nthe first biosimilar available to treat cancer patients in the country. Based on\nstrict regulatory legislations, biosimilars are expected to deliver affordable yet\neffective and safe treatment options all over the world, expanding the access to\ncancer treatment and reducing inequalities....
Biosimilars have received much attention from sponsors and regulatory authorities while patents on many biological products had expired recently or will soon expire in the next few years. According to the definition of biosimilar product from the European Medicines Agency�s guidance and the U.S. Food and Drug Administration�s guidelines, biosimilar should be highly similar, not identical, to the innovative biological product. In this research, we focus on establishing posterior criterion to assess the biosimilarity between the biosimilar product and the innovator product. We consider the prior information of the reference product and a non-informative prior to build the mixture empirical prior information of the biosimilar product. We further construct a posterior criterion to check the biosimilarity between the reference product and the biosimilar product. If the posterior probability of the similarity criterion is higher or equal to a pre-specified level, the biosimilarity between the reference product and the biosimilar product will be concluded. The statistical properties of the proposed approach are discussed through numerical results in different scenarios. A real example is provided to illustrate applications of the proposed approach....
This policy research aims to map patient access barriers to biologic treatments, to explore how increased uptake of biosimilars may\nlower these hurdles and to identify factors limiting the increased utilisation of biosimilars. A policy survey was developed to review\nthese questions in 10 Central and Eastern European (CEE) and Commonwealth of Independent States (CIS) countries. Two experts\n(one public and one private sector representative) fromeach country completed the survey.Questions were related to patient access,\npurchasing, clinical practice, and real-world data collection on both original biologics and biosimilars. Restrictions on the number\nof patients that can be treated and related waiting lists were reported as key patient access barriers. According to respondents,\nfor both clinicians and payers the primary benefit of switching patients to biosimilars would be to treat more patients. However,\nconcerns with therapeutic equivalence and fear of immunogenicity may reduce utilisation of biosimilars. Similar limitations in\npatient access to both original biologics and biosimilars raise concerns about the appropriateness and success of current biosimilar\npolicies in CEE and CIS countries. The conceptual framework for additional real-world data collection exists in all countries which\nmay provide a basis for future risk-management activities including vigorous pharmacovigilance data collection....
A biosimilar is a biologic product that is similar to a reference biopharmaceutical product, the manufacturing process of which\nhinders the ability to identically replicate the structure of the original product, and therefore, it cannot be described as an absolute\nequivalent of the original medication. The currently available technology does not allow for an accurate copy of complex\nmolecules, but it does allow the replication of similar molecules with the same activity. As biosimilars are about to be introduced in\noncology practice, these must be evaluated through evidence-based medicine. This manuscript is a position paper, where the\nBrazilian Society of Clinical Oncology (SBOC) aims to describe pertinent issues regarding the approval and use of biosimilars in\noncology. As a working group on behalf of SBOC, we discuss aspects related to definition, labeling/nomenclature, extrapolation,\ninterchangeability, switching, automatic substitution, clinical standards on safety and efficacy, and the potential impact on financial\nburden in healthcare. We take a stand in favor of the introduction of biosimilars, as they offer a viable, safe, and cost-effective\nalternative to the biopharmaceutical products currently used in cancer. We hope this document can provide valuable information to\nsupport therapeutic decisions that maximize the clinical benefit for the thousands of cancer patients in Brazil and can contribute to\nexpedite the introduction of this new drug class in clinical practice. We expect the conveyed information to serve as a basis for\nfurther discussion in Latin America, this being the first position paper issued by a Latin American Oncology Society....
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