AN OVERVIEW OF BIOSIMILARS


Nagaraj B Malipatil, Kiran Haridas, Shruthi D Prithvi

Abstract


Biosimilars are surmounting pharmaceutical market from last three decades and sale increasing progressively. Advances in the biotechnology
lead to development and discovery of new biological products to treat various life-threatening diseases. Biosimilars are biological drugs that are
produced after expiry of the patent of approved innovator. This review attempt to highlight the differences between biosimilars and chemical generics,
development stages, issues of concern with the use of biosimilars and need of appropriate regulations for their approval. Generic approach is not
scientifically useful to manufacture biosimilars. Biosimilars have more structural complexity, multi-layered manufacturing or scale-up process and
risk of immunogenicity; therefore required unique regulatory pathways to introduce them in the market. Safety and efficacy of biosimilar are essential
parameter to increase access in the population. Biosimilars can ensure the cost-effective treatment to invade incurable diseases due to enhanced
competition in pharma/biotech industries to manufacture it.
Keywords: Biosimilars, Biologics, Follow-on biologics, Generic drugs, Subsequent-entry biologics.


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About this article

Title

AN OVERVIEW OF BIOSIMILARS

Date

01-09-2015

Additional Links

Manuscript Submission

Journal

Asian Journal of Pharmaceutical and Clinical Research
Vol 8 Issue 5 (September - October) 2015 Page: 23-27

Print ISSN

0974-2441

Online ISSN

2455-3891

Statistics

1335 Views | 206 Downloads

Authors & Affiliations

Nagaraj B Malipatil
Former Post graduate, Department of Pharmacology, M R Medical College, Gulbarga, Karnataka, India, 585105.
India

Kiran Haridas
Former Post graduate, Department of Pharmacology, Kasturba Medical College, Mangalore, Karnataka, India, 575001.
India

Shruthi D Prithvi
Former Post graduate, Department of Orthodontics and Dentofacial Orthopedics, Dayanand Sagar College of Dental Sciences, Bangalore, Karnataka, India, 560078.

 

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