A Review on Biosimilar – A Medicine from the Life and for the Life
Dnyanda Kangude, S. D. Mankar
Pravara Rural College of Pharmacy, Pravaranagar.
*Corresponding Author E-mail: sdmankar655@gmail.com
ABSTRACT:
The medicine that is very close in structure and function to biological drugs. Biological drugs are the drugs made from proteins or are piece of proteins. They are naturally or artificially unlike other drugs. Biological drug must be made in living system like yeast, bacteria or animal cells using biotechnology tools. As drug, biologic have several advantages over small molecule. Biologics are very target – specific and their side – effects are mostly related to exaggerated pharmacological effect. Whereas small molecule are more prone to induce harmful non - target effect. Manufacturing a biologic consist of genetically modifying a cell, which become the basis for a cell line used for the production of the necessary protein for biologic medicine. As per the evaluated report of pharm use of biosimilar contributing to 50% of top pharma sales by 2022. Biosimilar are approved according to their safety, quality and efficacy which is apply to all biological medicine. Biosimilar are highly similar to biological medicine.
INTRODUCTION:
Biosimilar are biological product that is very close in structure and function to biological drug. These is not the exactly the copy of reference biological product.
This high similarity is obtained due to their exact same sequence of amino acid sequence of protein structure1.
There will be a not any structural difference between biosimilar and that of biological product. But in biosimilar, we can not expect the exact copy of reference biological product. because in production of biological product there also having a variation in batch to batch production. Biosimilars can also differ in 3D structure, isoform profile. In other words biosimilars are “the twin but not the clone “to original biologic product. Biosimilar is a medicine that is very close in structure and function to biological drugs2.
WHAT IS BIOSIMILAR:
First thing is that it is a biological products. A biological products is a very complex product produce in living system such as bacteria, yeast. A biological system is a living system so it is difficult to control in a same way as you going on synthesis. Again is a complex molecule there or more complicated to many fractional then it get complex with small molecule and that’s make the package of engeneric of chemically synthesize product3. They have same structure, same sequence of amino acid, same primary, secondary, tertiary structure. but there will be a clinically differences in the product. FDA is std. to approved the product be able to lable the product safe and effective for it’s use is the same.
FDA DEFINATION:
According to FDA “The biologic product is highly similar to the reference product not with stand minor difference in clinical inactive components and that there are no clinically meaningful differences between the biologic product and the reference product in terms of safety, purity and potency of the product. Ideally, the FDA’s finalized guidelines will establish a regulatory path for biosimilars that will ensure patient safety, control development cost, and encourage innovation by manufacture4. FDA Draft Guidance on the biosimilars Regulatory Pathway. In February 2012, the FDA issued three draft guidance documents regarding the regulatory requirements for biosimilars: These documents clarify the requirements of the BPCIA and discuss the scientific and quality considerations involved in evaluating the comparability of a biosimilar with a reference product.
BIOLOGIC VERSUS SMALL MOLECULE DRUG:
Other the basic difference of size, the main difference between these two therapeutic modalities is that “While small molecule drug are chemically derived, biologics are extracted from living organism. About 35 years ago, advances in biotechnology enabled synthesis of certain biological molecule in micro organism and other living cells using recombinant DNA technique from these discovery and innovation the real meaning of biologic has expanded to include wide range product5. Biologic include
1. Blood components
2. Cellular and tissue therapy
According to physiochemical property small molecule drug and therapeutic protein differ substantially. physiochemical property affect non only the pharmacological aspect of drug. (pharmacokinetic and pharmacodynemic) But the safety and efficacy6.
Biosimilars will assist healthcare system globally to ensure that more patients than ever before have access to safe, effective and affordable treatments, often with better safety profiles than generic treatment options.
MANUFACTURING OF BIOSIMILAR:
Biosimilar are considered to below – cost substitution for pricy, large – molecule biologics. However, the biosimilar having the identical quality, safty and efficacy as their reference class of drug that are produce using a living system such as microorganism, plant cell and animal. Manufacturing biosimilars requires a more complicated procedure than that a manufacturing small molecule generics7. Those are the companies construct the biosimilar are concentrated on developing a chemical structure that is similar or close to that of reference product. Many small molecule are developed by using the identical active pharmaceutical ingredient (API) and hence they are chemically similar to discovered medicine8.
The manufacturing process for small molecules comprises only one fifth of the total in process tests required to meet good manufacturing practice compared to that of biologic medicines. Absolutely, the manufacturing process for a large molecule is so complicated. It can not be duplicated by two different manufacturers, as the cells used in biologic medicines are unique to the company manufacturing each biologic9.
Manufacturing a biologic consist of genetically modifying a cell, which becomes the basic for a cell line used for the production of the necessary protein for the biologic medicine. The protein is then separated from the cell and purified. Biosimilars are created from small alterations to the manufacturing process which create a molecule that is not identical but closely resembles that reference product. But the changes in biosimilar molecule might be less. These different changes in the manufacturing process can affect the properties a biosimilar like their safety, efficacy. Compared to the reference biologic. Over the past decade, the manufacturing process for protein has becomes more standardized and the required technology has becomes increasingly accessible leading to reductions in biosimilars production costs. As a result, a greater number of companies have begun manufacturing biosimilars, while reference brand manufacturers are setting their slights on bolstering pipelines and manufacturing biobettes. Patents for many branded biologics will expire during the next few years, allowing biosimilars manufacturers to seek FDA approval for generic versions of these agent10. These criteria have inspired debate and the emergence of several critical issues, such as the what extent the biosimilars pathways should be abbreviated. Clinical data required for approval or current standard of care in clinical trials as comparable demonstration of safety and efficacy of molecule. The development of biosimilar product are more efficient than other types of molecule means the amount is reduced. Biosimilars do not required initial research as they known about the therapeutic target / remedial purpose. Their is no requirement of side effect, efficacy and dosage of the biosimilar product as they have same as that off original product.
Reliability of the product and requires amount for the operations are major challenge for the companies related to manufacturing biosimilars products as compared to small molecule manufacturing11.
OBJECTION AND SIDE EFFECT:
In that there are manufacturing objection for the biosimilar. In the firstly it is quite difficult or hard to express, outcome and copy the most small molecule drug. But the small changes occur or produce in the manufacturing that can alter the safety and efficacy12.
FDA approve the minor changes in the process. Achieving the exact product is challenging and expensive in different batches of same product.
There is uncertainty over legal factors concerning patent and trade secrets.
As the approved biosimilar are having great market for the short time period because of the another entry of the biosimilar. In many countries that having a specific pathways to market the biosimilar which involve in treatment13.
SAFETY, EFFICACY AND QUALITY OF BIOSIMILAR:
Rigorous testing has shown over and over again that switching between a biosimilar and a reference biologic has no impact. We have eight biosimilar in the market now globally14. The real – world clinical evidence that’s accumulated by the use of these biosimilars has demonstrated repeatedly there’s no negative safety, efficacy impact, quality attributes are constantly maintained and that patients can use these medicines safely, whether we are taking about a reference biologic or it’s biosimilar15. Institutional and managed care pharmacists generally view biosimilars as having significant potential to expand patient access to these important treatments. However, a lack of awereness and information regarding these agents on the part of health care professionals is one of the most significant problem that hinder adoption of biosimilars.
PHARMACOVIGILANCE OF BIOSIMILAR:
As per the indian guidance for biosimilar all MAHs of biosimilar should have an RMP for their biosimilars. This guidance also state that additional safety data may need to be collected after marketing approval through a predefined single – arm. It means that after marketing approval safety data required to study these on selected people and their history of reference biologic. The study should be completed preferable with in 2 years of the marketing permission / manufacturing license. The pharmacovigilance program in biosimilars it include both postauthorization safety studies and postauthorization studies16.
CONCLUSION:
Medicine will becomes an important part of healthcare in future. Now, the properly regulated biosimilar are increasingly more available. These biosimilar is one of the another or alternative treatment to physicians. All doctors are well known about the safety, quality and efficacy of biosimilars. As per the evaluate pharma report use of the these biosimilar drug will continue to rise contributing to 50% of the top pharma sales.
Biosimilar product required grater investment in research and development.
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Received on 22.02.2023 Modified on 12.03.2023
Accepted on 29.03.2023 ©Asian Pharma Press All Right Reserved
Asian J. Pharm. Res. 2023; 13(2):92-94.
DOI: 10.52711/2231-5691.2023.00018