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.

2. 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.

3. 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.

5. 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