Therapeutic proteins are next-generation drugs in the prevention and treatment of diseases, in particular human critical illness. The expiration of patents in the originally approved biopharmaceutics has stimulated a great excitement and the subsequent development of ââ?¬Å?follow-onââ?¬Â versions of these first-in-line biotherapeutic products, known as ââ?¬Å?Biosimilarsââ?¬Â or ââ?¬Å?Biobettersââ?¬Â. Biosimilars are a new class of drugs intended to offer comparable safety and efficacy (or clinical equivalence) to their original reference products which are brand name drugs and no longer under patent coverage. However, preparing exact copies of biologicals is much more challenging than replicating small molecules due to their structural complexity, intricate manufacturing processes and their potential risks for increased immunogenicity. Therefore, specific regulatory approval pathways and guidelines must be followed when creating Biosimilars. This article reviews the requirements and key considerations for producing Biosimilar agents as well as the important Biosimilar guidelines/regulations from different countries including the World Health Organization, Food and Drug Administration and the European Medicines Agency.\n\nConclusion\n\nPatents that expired or are soon to expire have provided a great opportunity for companies to make copies or ââ?¬Ë?genericââ?¬â?¢ versions of these drugs. Despite some challenges, therapeutic development of lower cost Biosimilars will inevitably enter the drug market in the near future, increasing the market competition and patients' access to the more cost-effective therapies that they may not have otherwise.
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