Posted: July 16th, 2022

This week, Lecture 8 and the assigned reading covers a very important and timely

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This week, Lecture 8 and the assigned reading covers a very important and timely topic – Biosimilars. Before we discuss biosimilars, you will be learning about the submission process for BLAs or Biologics License Application. This is a continuation from Week 5 when you first read about biologics. Please take time to review the readings to refresh your memory with regards to biologics and then take the time to gain an understanding of BLAs and the BLA process. Biosimilars are biological products that the FDA considers “highly similar” or in face “interchangeable” with a previously FDA-approved biological product (biologics). The use of biosimilars is very advantageous for corporations because their use can save time, resources and additional animal or human testing. ********** In your opinion, does this saving ultimately translate to the consumer? Further explain the difference between generic drugs and biosimilars. Are either of these more advantageous to produce – cheaper, faster production to market, less resources needed to produce? To conclude your assessment, which would the consumer benefit from more, generic drugs or biosimilars?

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