Biological products, such as monoclonal antibodies and recombinant proteins, are drugs made up of living organisms via enormously complicated producing procedures. To ensure the patients safety, biologics should be handled and administered underneath rigorously monitored standards and circumstances. This kind of medications mostly play a key role in treatment of autoimmune disorders and terminal diseases such as cancer.
A biosimilar is precisely what its term denotes; a biologic product which is highly “similar” to an already licensed biologic medicine (reference). There are high similarities between the safety, purity and potency attributes of biosimilars and the references; however, some negligible variances in clinically inactive parts are acceptable according to guidelines.
Mostly in approval of biosimilars process to ensure the safety, purity and potency of the proposed medicines, it is necessary to perform Phase I and III clinical trials under authorities monitoring.