[Biosimilars].

Author: KrämerIrene

Paper Details 
Original Abstract of the Article :
Biosimilars are biological medicinal products referring to an existing biological originator product and submitted to regulatory authorities formarketing authorization by an independent applicant after the patent has expired. The European Medicines Agency (EMA) has issued overarching and specific gu...See full text at original site
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引用元:
https://doi.org/10.1024/0040-5930/a000227

データ提供:米国国立医学図書館(NLM)

Biosimilars: Navigating the Complex World of Biological Medicines

The realm of [biosimilars] is complex, and this study dives into the intricacies of these biological medicines. It explores the regulatory landscape and the stringent guidelines that govern the approval of biosimilars, ensuring their safety and efficacy. The study highlights the need for [clear communication and transparency] as we transition from innovator products to biosimilars, especially when switching between different biosimilars.

Similar but Not Identical

Biosimilars are like navigating a vast desert landscape, where we encounter similar but distinct sand dunes. They are not exact replicas of the original biological medicines but are designed to be very similar in terms of quality, safety, and effectiveness. The European Medicines Agency (EMA) has set out specific guidelines for ensuring this similarity.

Navigating the Biosimilar Desert

This research provides crucial insights for navigating the evolving landscape of biological medicines. As we venture into the desert of biosimilars, understanding the nuances of these complex medications is essential. Clear communication and transparency from healthcare providers are key to ensuring patient safety and optimal outcomes.

Dr. Camel's Conclusion

The emergence of biosimilars marks a significant evolution in the world of biological medicines. Like exploring a vast desert, we must be cautious and informed when navigating this new terrain. This study sheds light on the regulatory processes and the key considerations for ensuring the safe and effective use of these medications.

Date :
  1. Date Completed 2012-03-01
  2. Date Revised 2013-11-21
Further Info :

Pubmed ID

22045529

DOI: Digital Object Identifier

10.1024/0040-5930/a000227

Related Literature

SNS
PICO Info
in preparation
Languages

German

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