Abstract

Biosimilar Drugs in Albania “current situation”

Highlights

  • The use of biologicals is very important in the treatment of mild illnesses ranging from anaemia to life threatening cancers and neurological disorders

  • For the first time the definition Biosimilar was mentioned in Albanian legislation in 2014, Law No.105/2014, 31.07.2014 “On drugs and pharmaceutical service”, amended: A biosimilar is a biological drug that is highly similar to another biological drug which already has a marketing authorization and has the same active ingredient, dosage form and route of administration as the reference product, for which it is determined through a quality, safety and efficacy program

  • There are 14 biosimilars, authorized for marketing in Albania designed for different diseases, from different marketing authorization holders

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Summary

Introduction

The use of biologicals is very important in the treatment of mild illnesses ranging from anaemia to life threatening cancers and neurological disorders. These biologics include products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues and recombinant therapeutic proteins [1]. The expiry of patents of these products created new opportunities for the development of similar biologics (biosimilars) that could offer comparable effective and quality healthcare at an affordable cost [2,3,4]. Efficacy and safety to their respective originator biologicals, strict compliance with appropriate science-based regulatory standards is essential to approve a biosimilar product [4]

Aim of the Review
Methods & Results
Conclusion
10. Albania reimbursement list 2018 database

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