Biosimilars & Biowaivers

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The Journal of Biosimilars & Biowaivers (JBSBW) promotes rigorous research that makes a significant contribution in advancing knowledge for Biosimilars. The journal includes all major themes pertaining to manufacturing process for biopharmaceuticals & waivers of clinical bioequivalence.

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Biosimilars & Biowaivers

  1. 1. Biosimilar  A biotherapeutic item which is similar with regards to quality, protection and effectiveness to an already certified referrals biotherapeutic item.  A biosimilar is a scientific item that is highly similar to a US-licensed referrals scientific item despite minimal variations in medically non- active elements.  For which there are no medically significant variations between the scientific item and the referrals item in terms of the safety, cleanliness, and efficiency of the item.
  2. 2. Biowaivers  In easy terms, a Biowaiver is a waiver (exemption) of medical bioequivalence research given to a medication item.  'The phrase biowaiver is used to a regulating medication acceptance procedure where the effectiveness and protection aspect of the file (application) is accepted depending on proof of equivalence other than through in vivo equivalence examining.  Biowaiver Applications:  Antiretroviral drugs – abacavir, emtricitabine, lamivudine, stavudine and zidovudine;  Anti-tuberculosis drugs – ethambutol, isoniazid, levofloxacin, ofloxacin, moxifloxacin and pyrazinamide.
  3. 3. Development of Biosimilars  There are four levels in the growth of a biosimilar:  1) service and relative analysis;  2) procedure growth, range up and validation;  3) medical trials;  4) Regulating (EMA and FDA) evaluation and acceptance.  All levels come with different specifications and take different periods, all of which plays a role in the overall cost of creating a biosimilar

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