The Emergence of Biosimilars

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 do not require the tests on toxicity as well as other myriad pharmacological tests (Elliott, Foote & Molineux, 2009). The generic products are assumed to be perfectly identical to the reference products. The generic products trend in many healthcare systems and are known for better effects. Biosimilars can produce desirable effects; however, they do not have similar therapeutic indices as the generic combinations (Gad, 2007). Besides, the manufacture of the biosimilars requires a lot of comparisons to the reference drug. Nonetheless, the generic drug manufacture takes a stringent comparability tests that include tests for the safety, efficacy and suitability (Kayser & Warzecha, 2012).
Ideally, this paper explores the emergence of biosimilars, their comparison to the generic products as well as their importance in the medical fields. It will also explore some of the formidable challenges that are associated with the biosimilars. Biosimilars are common thus this paper will provide a list of approved biosimilars as well as the regulatory information and the boundaries that govern the trade and production of biosimilars. Additionally, some of the impacts and benefits of biosimilars will be discussed (Plitnick, Lisa & Herzyk, 2013).
ApprovedBiosimilars (Hodgson, 2009).


Challenges to the Emergence of Biosimilars
Schellekens (2005) illustrates that challenges Associated with Biosimilars requires a rigorous exercise in order to be approved. The process of developing biosimilars has various regulations that hinder the marketing process. In comparison to the generic drug development, the biosimilars have a lot of challenges. Usually, the major challenge is the synthesis process. The synthesis of these products must be elusive and proven enough to ensure safety during use of the products (Bryant, Knights & Salerno, 2010).
Since biosimilars lack bioequivalence of their reference products, they may not be easily tested. Drugs often require equivalence for testing the bioequivalence in order to ensure safety as well as efficacy. Most biosimilars require thorough tests in order to determine their biological effects. The properties of the chemical present in most of the biosimilar are complex making the process of testing hard. Minghetti et al (2012) illustrate that the molecules found in biosimilars often have broad target making the tests difficult to determine the specificity in the activity of the drugs (Bryant, Knight & Salerno, 2010).
The clinical effects of the biosimilars are so many. They induce multiple activities in the body systems of various individuals. Most researchers contend that despite the rigorous tests that they might carry, it is often easy to end up with no conclusive efficacy test. The drugs are often hard to evaluate. This is why their approval process becomes more technical since they lack credibility in their activity.
Tests for immunogenicity as well as the potency of the biosimilars are a demanding task. Such tests are considered hard tasks since they often lead to loss of the certain properties of the drugs. The biosimilars lose immunogenicity and solubility when put on glycosylation. During the tests, the drugs can also undergo various conjugation of the properties i.e. degradation as well as production of newer antigenic components. Studies show that the changes can be very dangerous to the hosts where the tests are carried. The potency as well as the half-life of the drugs can be altered as well to make it unsafe for use (Shein-Chung et al., 2011).
Manufacturers say that the drugs are prone to contamination during production. Biosimilars are haphazardly exposed to various microbes, antibiotics as well as other pathogens that may lead to contamination. This poses big risks to the quality and effects of the drugs on the host. The contaminants may provoke the ultimate process of immunogenicity. The impurities may modify and interfere with the intended activities making the drugs unsafe for use (Lanthier, Behrman & Nardinelli, 2008).
Effects on the 3D-structure may lead to various alterations in the activities. The drugs may be so irrelevant for use when their intended purposes hav...