BIOSIMILARS: A COMPLETE REVIEW ON MANUFACTURING, FDA APPROVAL, CASE STUDIES

A developing class of medications called biosimilars is created to be used interchangeably with biologics. In living cells, biologics are often large, complicated proteins with a range of potential applications. Biologics are utilised to treat malignancies, endocrine problems, and inflammatory bowel diseases just within the discipline of gastroenterology. Despite the fact that many diseases can be effectively treated or managed with biologics, patient access is frequently constrained by their high cost. The creation of biosimilars is an effort to lower the cost of medical care. In terms of efficacy, side effect risk profile, and immunogenicity, biosimilars must be essentially equivalent to their reference biologics. Biosimilars go through fewer clinical trials than their reference biologics, despite the manufacturing process still requiring manufacture within living cells. As a result, the biosimilar medication is less expensive to produce and purchase than the reference biologic. Seven biosimilars have currently received FDA approval for use in the treatment of Crohn’s disease, ulcerative colitis, and colorectal cancer. There are further biologics used to treat gastroenterological disorders for which no FDA-approved biosimilars exist. Although biosimilars have the potential to lower healthcare costs in the management of chronic diseases, they struggle to gain a sizable market share. Patients’ hesitation to move from a biologic to a biosimilar and doctors’ comfort in prescribing reference biologics rather than biosimilars are two major reasons for the delayed uptake of biosimilars. The establishment of a greater and more stable market share for biosimilars in comparison to their reference biologics will take longer time. To strengthen physician trust in biosimilars and patient comfort with biosimilars, more information proving the safety and efficacy of biosimilars, a greater selection of biosimilars, and further cost reduction of biosimilars will all be required. A “biosimilar” is a recently launched biologic product that, in terms of quality, safety, and efficacy, is comparable to an authorised “Reference Biologic” product. Biosimilars’ main goal is to lower healthcare expenses related to the use of biologics and so broaden access to healthcare. The bioequivalence technique is not thought to be suited for the approval of biosimilars, in contrast to small molecule generics.  They are already a key component of contemporary pharmacotherapy. Many original biotechnological drugs’ patent protections have expired, which has sparked the creation of what are known as biosimilars or follow-on biologics. In order to create a product that is comparable to the original, biosimilars try to replicate the original technology that produced new biotechnology treatments. In the European Union, the first two biosimilars have just received approval, while one application was denied. In the foreseeable future, many additional biosimilars are likely to receive approval. Our knowledge of biosimilars is relatively limited at this point, and there are no long-term safety data, including information on immunogenicity. Although biosimilars are likely to reduce the cost of modern therapies, there are still some concerns that need to be discussed among doctors at this point, particularly with regard to the differences between biosimilars and generic versions of the traditional chemical drugs, the requirement for appropriate regulations, and the identification of potential biosimilar issues. The advantages of biosimilars, manufacturing process of biosimilars, approval of biosimilars, and also case study with relevant monographs will also be covered in this study.