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6 pages/≈1650 words
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APA
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Life Sciences
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The Emergence of Biosimilars (Essay Sample)

Instructions:
* A report on the the emergence of biosimilars and implications for the global biologics industry. * The report will be 1500 words in length excluding references . * Contain the following information: \"( as subheading )\" 1- definition of biosimilars and the difference between generics in the pharmaceutical industry. 2- table approved biosimilars. 3-challenges to the emergence of biosimilars. 4-regulatory issues and considerations, 5- the different regulatory landscapes associated with approval of biosimilars in various countries; 6- impact on the global industry; future prospects. * Important I provide you with 16 articles , use at least 8 of them .(see the files) * for the references : Maximum 30% URL referencing (i.e. 70% refereed journal articles).( from 2009-2013) Important: See the files attached to know about the criteria and more details for this report. * I provide you with an example to know how the structure for this report, but please do not use it . source..
Content:
Running head: THE EMERGENCE OF BIOSIMILARS
The Emergence of Biosimilars
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The Emergence of Biosimilars
Introduction
Biosimilars are pharmaceutical products often known as biological products that are made through complex processes. They have complex pharmacological components and are made through a complex biotechnology. These products are often made on similar scientific approaches that imitate the generic products; however, these biosimilars do not have the same potency as the generic products. These products are presumably significant in managing health conditions, but require thorough tests and marketing evaluation through case studies to prove their efficacy and safety (Shorthose, 2011).
Difference Between Biosimilars and Generic Drugs
It is believed that the biosimilars are not very similar to the generic products. Nevertheless, biosimilars have good quality that is comparable to the quality of the generic drugs, good efficacy and safety. They are often made based on the reference products. The reference products for most biosimilars are the common generic medications. These products often require accurate evaluation using a patient who had previously used a reference product (Schellekens, 2009).
On the other hand, generic products are often trusted for their approved potency, efficacy and safety. Biosimilars often imitate the activities of the generic or reference products. Generic drugs are often made in an identical manner as the reference products (Sekhon & Saluja, 2011). Unlike the biosimilars, the generic drugs must have identical effects including similar doses used in the human system. The effects of the generic drugs must be proven and documented (Prugnaud & Trouvin, 2013).
However, the differences between the biosimilars and the generic drugs are many. Their manufacturing process is different. They have larger portion of active ingredient as compared to the generic counterparts. The complexity of the biosimilars is vast especially in the chemical composition (Al-Achi, Gupta & Stagner, 2013). Biosimilars have a large number of heterogenous proteins that have increased activity. They are comparatively expensive as compared to the generic drugs. Due to their doubted identity, they have a more complex regularity process as compared to the generic drugs (Georg-Burkhard, 2009).
Somers and United States (2010) acknowledge that generic drugs must have similar quality as the reference product. This includes up to the similarity in the amounts of the generic and reference drug used for specific conditions. Generic drugs must be used in similar events as their standard reference drugs. The therapeutic indices of the generic drugs are fairly comparable to the standard reference products thus can be safely interchanged as an alternative regimen in cases where standard reference drugs are unavailable (Schellekens, 2009).
Unlike the biosimilars, the generic drug tests...
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