- 作者：Ewa Olech ; MD eolech@unr.edu" class="auth_mail" title="E-mail the corresponding author ewaolech@yahoo.com" class="auth_mail" title="E-mail the corresponding author
- 关键词：Biosimilar ; Biologic ; Innovator ; Reference product ; Chronic inflammatory diseases ; Nomenclature ; Biosimilarity ; Regulatory guidance ; Regulatory pathways ; Generics ; Small-molecule drugs ; Development
- 刊名：Seminars in Arthritis and Rheumatism
- 出版年：2016
- 出版时间：April 2016
- 年：2016
- 卷：45
- 期：5_supp_S
- 页码：S1-S10
- 全文大小：811 K
Methods
An Internet-based literature search through April 2015 was performed for information related to biosimilars in chronic inflammatory disorders. Keywords were as follows: biosimilar, development, manufacturing, characterization, structural, functional, preclinical, clinical, immunogenicity, rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis, psoriatic arthritis, Crohn׳s disease, ulcerative colitis, and ankylosing spondylitis. The European Medicines Agency (EMA) and US Food and Drug Administration (FDA) websites were searched for guidelines and information related to biosimilars.
Results
Biosimilars are products that are highly similar to the reference product regarding quality, biological activity, safety, and efficacy. Biosimilars are biological products and not generic drugs and, thus, do not follow the same regulatory pathways as generic molecules. Rigorous early-stage structural, functional, and analytical testing, followed by nonclinical and clinical analyses comparing a biosimilar with its reference product, are required to demonstrate biosimilarity in regulatory markets worldwide.
Conclusions
The addition of biosimilars to the market has the potential to improve access to biologic therapies. Many regulatory agencies have enacted stringent pathways, which must be followed for a biosimilar to be labeled and approved as such; following the pathways will help protect and maintain the integrity, quality, and safety of the biosimilar product.