Journal of Pharmacovigilance

Renato Bertini Malgarini

Publications

• Review Article
  Biosimilars: Regulatory Status and Implications across the World
  Author(s): Rajesh Kumar, Sandra Sigala, Renato Bertini Malgarini, Giuseppe Pimpinella, Luca Pani, Sergio Pecorelli and Maurizio MemoRajesh Kumar, Sandra Sigala, Renato Bertini Malgarini, Giuseppe Pimpinella, Luca Pani, Sergio Pecorelli and Maurizio Memo
  
  Biological drugs, also known as first generation biopharmaceuticals, are being produced for the last 30 years and are in clinical use for a number of diseases. Recently, the expiry of many of these product patents led to the development of other non-innovator similar biologics at lower costs, having the same safety, purity and potency as their original counterparts. These non-innovator similar biologics are generally referred to as biosimilars. Biosimilars are produced in living organisms by recombinant DNA techniques and exploiting the cellular mechanisms of the host so, there could be some differences at the molecular level due to their complex nature. Henceforth, they have to face numerous challenges for their development and approval, including the complex manufacturing process, immunogenicity issues, nomenclature, extrapolation of different indications, interchangeabili.. View More»
  DOI: 10.4172/2329-6887.S3-002

  Abstract PDF