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

Biosimilar - Research Paper Example Although it is the hope that their introduction may lower the cost of such expensive medicinal products, there have been concerns over the introduction and manufacturing considerations, immunogenicity, degree of similarity of these complex 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 pharmacological indications are controversial, as well as differences between biopharmaceutical products not subjected to regulatory approval and regulatory approved 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, widespread availability of biopharmaceutical produ cts 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 efficacy 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 inappropriate and automatic substitution of a biosimilar for a reference biopharmaceutical product, and biosimilars should not be brought to market using the same 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 soon expire. This will allow other biotech/biopharmaceutical companies to manufacture the generic versions of the biological products, which are referred to as bi osimilar medicinal products by the European Medicine Agency of the European Union, or as follow-on biological products by the U.S. Food and Drug 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 heterogeneity of the molecular structure, complicated manufacturing process, different analytical methods, and possibility of severe