WJPR Citation New

  All Since 2011
 Citation  2903  2393
 h-index  27  24
 i10-index  68  60


Best Paper Awards

World Journal of Pharmaceutical Research (WJPR) will give best paper award in every issue in the form of money along with certificate to promote research activity of scholar.
            Best Paper Award :
Dr. Muhammad Baqir MR Fakhrildin
Download Article: Click Here


Track Your Article



Prof. Dr. Dhrubo Jyoti Sen*, Jahangir Nabi, Pooja Raj and Jainik Khamar


Biologics are 200 to 1,000 times the size of a small molecule (generic) drug and far more structurally complex. Additionally, biologics and biosimilars are manufactured in living cells, then extracted and purified, whereas small molecule drugs and generics are manufactured purely via chemical synthesis. These fundamental differences in complexity and large-scale manufacturing are at the core of why biosimilars are not equal to generics. Biologics and biosimilars are produced in living cells with a multi-step process. Initially, a basic protein structure is ―translated‖ from a DNA sequence and then modifications, including changes and additions, are made to that basic protein structure. These later changes and additions are called posttranslational modifications. The impact of post-translational modifications on a product is similar to the impact of a farming environment on growing tomatoes. The look and taste of the same type of tomatoes will vary in different farm environments because of the quality of the soil, use of fertilizers, type of irrigation and weather elements like rain, air, sunlight. Similarly, differences in biological systems (e.g., type of living cell with slightly different cellular environments) used to manufacture biosimilars may cause different types and levels of modifications, which in turn may affect the quality, safety or effectiveness of the product. So, whereas a generic can be identical to a small molecule reference product, biosimilars cannot and are not required to be exactly like the biologic reference product. Given the expected differences, regulatory authorities have outlined robust data requirements to demonstrate similarity. Biosimilar manufacturers will generally need to generate data from lab testing, non-clinical testing and clinical testing to show that the biosimilar they have developed will provide the same therapeutic benefit and risks to patients as the reference product.

Keywords: Darbepoetin alfa, Etanercept, Epoetin alfa, Somatropin, Trastuzumab, Adalimumab, Pegfilgrastim, Filgrastim, Infliximab, Rituximab, Bevacizumab, Lispro, Glargine.

[Full Text Article]

Call for Paper

World Journal of Pharmaceutical Research (WJPR)
Read More

Email & SMS Alert

World Journal of Pharmaceutical Research (WJPR)
Read More

Article Statistics

World Journal of Pharmaceutical Research (WJPR)
Read More

Online Submission

World Journal of Pharmaceutical Research (WJPR)
Read More