Biojournal of Science and Technology (BJST)

A Scholarly Journal for Biological Publications

Biojournal of Science and Technology
Volume 2, ISSN:2410-9754, Article ID: m150003

Review Article

A Global Perspective of the Prospects and Challenges of an Awaiting Revolution of Biosimilars

Muhammad Sougatul Islam1, Masih Ul Alam2 and Munia Amin2

1 CVS, International Centre for Diarrheal Disease Research, Bangladesh

2, ImmunoSys Ltd., UK

Date of Acceptance: Saturday, October 10, 2015
Date of Published: Friday, November 6, 2015

Address corresponds to
Dr Munia Amin
Business Development Associate, ImmunoSys Ltd. UK, 18/29 Darussalam, Mirpur, Dhaka 1216
Email:muniaamin14@gmail.com

Acedemic Editor: Editor-in-Chief

To cite this article
Muhammad Sougatul Islam, Masih Ul Alamand Munia Amin.A Global Perspective of the Prospects and Challenges of an Awaiting Revolution of Biosimilars.Biojournal of Science and Technology.Vol:2,2015

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ABSTRACT

Therapeutics derived through application of modern biotechnology has become an essential component of contemporary pharmacology and clinical medicine. Biopharmaceuticals have given an unprecedented edge to humanity to treat many formidable diseases. It has been anticipated that biotechnological medicines will occupy 50% share of pharmaceutical market by next decade. The first ever biotech drug came into use by the advent of recombinant insulin in early 80's. Since then many biologics including recombinant human protein and monoclonal antibodies followed that changed the world of therapeutics. All these came through years and years of intensive research and at the cost of huge investments. Now we are passing through a time when some of the biologics have lost patent protection and many are moving towards it. "Patent Cliff" is a well noticed term nowadays in biopharmaceutical industry that opened the scope for "biosimilars" entry into therapeutic market. This simply means that the expiry of patent protection for many original biopharmaceuticals or biologics has led to the development of newer versions of original products. These similar products are called "biosimilars" or "non-original biologics". Biosimilars are also innovative biotechnology medicines but copy the original technology to obtain a therapeutic what is similar to the original one. However, there might be differences on a protein level depending on the biological process of manufacturing. Biosimilars represent the newer class of biotech medicinal products that have been anticipated to have significant impact on therapeutics market. Biosimilars development is currently one of the fastest growing areas in biopharmaceuticals industry because of incumbent patent expiry of top 12 best-selling biologics. In June 2013, world's first biosimilar of infliximab, Remsima® (CT-P13) developed by Celltrion, was approved by the Committee for Medicinal Products for Human Use (CHMP) of European Medicine Agency (EMA). Many more biosimilars are in the pipeline and some are awaiting approval. Biosimilar approval has evoked a competition in global market targeting the blockbuster biologics. The underlying reason is that biosimilars will dramatically reduce the cost of treatments where biologics are predominating. Moreover, a recent advance in technology in biopharmaceutical industry allows showing similarity between originator and biosimilar product. Although biosimilars are emerging in the market and their market share is increasing although there are many issues raising the concerns such as safety, immunogenicity, regulatory processes, pharmacovigilance, automatic substitution, naming and labelling rules. Recent evidences have been able to demonstrate quality, efficacy, and safety of biosimilars whereas a lack of interchangeability and international standards has to be addressed. Here we provide a brief overview of biosimilars development, its increasing uses and market value as well as opportunities for emerging pharmaceutical industries.