Biosimilar Research Paper Example | Topics and Well Written Essays - 1500 words

Biosimilar - Research Paper ExampleAlthough it is the hope that their introduction may lower the damage of such costly medicinal crossroads, there seduce been concerns over the introduction and manufacturing considerations, immunogenicity, degree of similarity of these difficult drugs, and regulatory approaches to biosimilars around the world. In addition, of concern are arguments and techniques employed by pharmaceutical companies to advance or discredit biosimilars, as well as issues with post-marketing surveillance programs and their limitations. The issues associated with introduction of biosimilar medicines across a range of pharmacologic indications are controversial, as well as differences between biopharmaceutical wares not subjected to regulatory approval and regulatory sanction medicines. There are rapid changes in licensing of biosimilars and regulatory approval. Non-transparent promotion of biosimilar products gives clinicians a need to be wary. Hopefully, genera l availability of biopharmaceutical products will be provided by biosimilar medicines (Roger, 2010). ... The manufacture of a biopharmaceutical involves several isolation and purification steps, and the product is complex. In terms of safety and skill of the product, even minor changes in production can have serious implications, and these procedures are proprietary to the manufacturer of the originator product. Existing and future regulation should prevent out or keeping(p) and automatic substitution of a biosimilar for a reference biopharmaceutical product, and biosimilars should not be brought to market using the identical procedure applied to generics (Misra A, 2010). Living systems or organisms are used to produce biological products, medicines, and therapeutic agents. Because of their expensive cost, access to these life-saving biological products is limited. In the next few years, patents on the early biological products will briefly expire. This will allow other biotech/b iopharmaceutical companies to manufacture the generic versions of the biological products, which are referred to as biosimilar medicinal products by the European Medicine Agency of the European Union, or as follow-on biological products by the U.S. Food and dose Administration. Increase in patients access to the much-needed biological pharmaceuticals by competition of cost-effective follow-on biological products with equivalent efficacy and safety can cut down the costs. Evaluation of equivalence (similarity) between the biosimilar products and their corresponding innovator product is a great challenge for both the scientific community and regulatory agencies due to the complexity and heterogeneousness of the molecular structure, complicated manufacturing process, different analytical methods, and possibility of severe