Clinical Similarity of Biosimilars and Reference Drugs: A Comprehensive Review and New Hope for Public Health in a New Frontier.

Background: Patents and exclusive rights on reference biologics contribute to the emergence of biosimilars. Regulatory bodies, such as the Food and Drug Administration (FDA), World Health Organization (WHO), and EMA (European Medicines Agency) for assessing clinical safety, effectiveness, and consequences between biosimilars and reference medications, have established guidelines. Since generic small molecules from reference can be easily swapped, biosimilars cannot be used interchangeably and may not always indicate interchangeability due to highly restrictive properties.

Polyamide/Poly(Amino Acid) Polymers for Drug Delivery.

Polymers have always played a critical role in the development of novel drug delivery systems by providing the sustained, controlled and targeted release of both hydrophobic and hydrophilic drugs. Among the different polymers, polyamides or poly(amino acid)s exhibit distinct features such as good biocompatibility, slow degradability and flexible physicochemical modification. The degradation rates of poly(amino acid)s are influenced by the hydrophilicity of the amino acids that make up the polymer.