COCERIG ISSUES WITH BIOSIMILARS: AOVERVIEW
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Summary Biopharmaceuticals are biological medicinal products that have been developed through biotechnological practices, including recombinant human technology, gene technology or antibody methods. The imminent patent expiration of many biopharmaceutical products will produce the possibility for generic versions of these therapeutic agents (i.e.biosimilars). Biosimilars differ from generic low molecular weight chemical drugs in many important ways. These include the size and complexity of the active substance, which will affect the scientific requirement for testing; the nature of the starting materials (cell banks, tissues, and other biological products); the complexity of the manufacturing processes; and the limitations of state-ofthe-art methods to characterize proteins and to detect all product variations that can influence clinical efficacy, sideeffects like immunogenicity. Therefore, it was acknowledged that established legal and regulatory principles of ‘essential similarity’ that are applied to standard generics cannot be readily applied to biosimilars. Thus, verification of the similarity to or substitutability of biosimilars with reference innovator biopharmaceutical products will require much more than a demonstration of pharmacokinetic similarity, which is sufficient forKeywords:
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The new biotechnology has opened the door to a very broad array of new pharmaceutical products which lend themselves to high degrees of purity and potency. From a regulatory point of view, the two basic questions of safety and efficacy are central to their approval for marketing. The kinds of safety tests which should be done on these new products will be discussed, as will the novel safety issues related to the use of abnormal mammalian cells as substrates for the production of some new drugs and biologicals. In addition, the relative need for efficacy studies will be discussed in the context of a genetically engineered product when the "natural" product has already been shown to be effective and is commercially available.
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Abstract The number of approaches to recombinant protein production in plants is greater than ever before. Development of these new and improved technologies as production platforms for plant‐made pharmaceuticals has and will continue to create new commercial opportunities in the pharmaceutical sector. However, it is inevitable that no single system will be optimal for the production of all recombinant proteins of interest in plants due to both the physical characteristics and the envisaged therapeutic application of each product. Here, we review a range of promising product/platform pairs emphasizing synergies during production and in clinical trials.
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Many patents for the first biologicals derived from recombinant technology and, more recently, monoclonal antibodies (mAbs) are expiring. Naturally, biosimilars are becoming an increasingly important area of interest for the pharmaceutical industry worldwide, not only for emergent countries that need to import biologic products. This review shows the evolution of biosimilar development regarding regulatory, manufacturing bioprocess, comparability, and marketing. The regulatory landscape is evolving globally, whereas analytical structure and functional analyses provide the foundation of a biosimilar development program. The challenges to develop and demonstrate biosimilarity should overcome the inherent differences in the bioprocess manufacturing and physicochemical and biological characterization of a biosimilar compared to several lots of the reference product. The implementation of approaches, such as Quality by Design (QbD), will provide products with defined specifications in relation to quality, purity, safety, and efficacy that were not possible when the reference product was developed. Actually, the need to prove comparability to the reference product by the biosimilar industry has increased the knowledge about the product and the production-process associated by the use of powerful analytical tools. The technological challenges to make copies of biologic products while attending regulatory and market demands are expected to help innovation in the direction of attaining more productive manufacturing processes. © 2015 American Institute of Chemical Engineers Biotechnol. Prog., 31:1139–1149, 2015
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Combination products with a wide range of clinical applications represent a unique class of medical products that are composed of more than a singular medical device or drug/biological product. The product research and development, clinical translation as well as regulatory evaluation of combination products are complex and challenging. This review firstly introduced the origin, definition and designation of combination products. Key areas of systematic regulatory review on the safety and efficacy of device-led/supervised combination products were then presented. Preclinical and clinical evaluation of combination products was discussed. Lastly, the research prospect of regulatory science for combination products was described. New tools of computational modeling and simulation, novel technologies such as artificial intelligence, needs of developing new standards, evidence-based research methods, new approaches including the designation of innovative or breakthrough medical products have been developed and could be used to assess the safety, efficacy, quality and performance of combination products. Taken together, the fast development of combination products with great potentials in healthcare provides new opportunities for the advancement of regulatory review as well as regulatory science.
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The article presents an outline of the requirements concerning the planning of preclinical and clinical studies, necessary for the legal approval of a medicinal product. It describes the clinical research plan of innovative and generic pharmaceutical products, taking into account the specific situations in which the assessment of biological equivalence of a generic product is not possible based on pharmacokinetic parameters. The article also discusses the guidelines which determine the scope of studies which are necessary in the process of registration of biotechnological and biosimilar products.
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Before there can be acceptance of natural health products (NHPs) or "phytomedicines" by the Western medical community, questions related to active ingredients, mechanisms of action, toxicology, and drug interactions will need to be satisfactorily addressed. Since NHPs are generally manufactured from highly variable raw materials, identifying the therapeutically active ingredients can be challenging. Standardization according to all known bioactive components is critical to ensure consistent pharmacological and clinical results. CV Technologies, Inc. has made great strides in resolving these challenges through the patented technology, ChemBioPrint. During early ChemBioPrint product development, the optimal active components of a natural extract are identified and characterized chemically (chemical fingerprinting) and pharmacologically through a variety of activity assays (biological fingerprinting). Subsequent manufacturing steps ensure each batch is standardized accordingly and has consistent composition and efficacy. Case studies will be presented on two commercially available ChemBioPrint products: COLD-fX (an immune-modulator) and REMEMBER-fX (a neuro-modulator). Unique and important structure-function relationships exist between the major classes of bioactive molecules from the shared source material of these two products, Panax quinquefolius. Through numerous published and ongoing clinical trials and pharmacological studies, these ChemBioPrint products have been shown to be consistent, safe and effective. The future directions of NHP research will be discussed, including the requirements for accurate reporting of study results related to ingredient and standardization descriptions.
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