An Overview of Biosimilars-Development, Quality, Regulatory Issues, and Management in Healthcare.

Biological therapies have transformed high-burden treatments. As the patent and exclusivity period for biological medicines draws to a close, there is a possibility for the development and authorization of biosimilars. These products boast comparable levels of safety, quality, and effectiveness to their precursor reference products. Biosimilars, although similar to reference products, are not identical copies and should not be considered generic substitutes for the original. Their development and evaluation involve a rigorous step-by-step process that includes analytical, functional, and nonclinical evaluations and clinical trials. Clinical studies conducted for biosimilars aim to establish similar efficacy, safety, and immunogenicity, rather than demonstrating a clinical benefit, as with the reference product. However, although the current knowledge regarding biosimilars has significantly increased, several controversies and misconceptions still exist regarding their immunogenicity, extrapolation, interchangeability, substitution, and nomenclature. The development of biosimilars stimulates market competition, contributes toward healthcare sustainability, and allows for greater patient access. However, maximizing the benefits of biosimilars requires cooperation between regulators and developers to ensure that patients can benefit quickly from access to these new therapeutic alternatives while maintaining high standards of quality, safety, and efficacy. Recognizing the inherent complexities of comprehending biosimilars fully, it is essential to focus on realistic approaches, such as fostering open communication between healthcare providers and patients, encouraging informed decision-making, and minimizing risks. This review addresses the regulatory and manufacturing requirements for biosimilars and provides clinicians with relevant insights for informed prescribing.

Application of nanotechnology in management and treatment of diabetic wounds.

Diabetic wounds are one of the most common health problems worldwide, enhancing the demand for new management strategies. Nanotechnology, as a developing subject in diabetic wound healing, is proving to be a promising and effective tool in treatment and care. It is, therefore, necessary to ascertain the available and distinct nanosystems and evaluate their performance when topically applied to the injury site, especially in diabetic wound healing. Several active ingredients, including bioactive ingredients, growth factors, mesenchymal stem cells, nucleic acids, and drugs, benefit from improved properties when loaded into nanosystems. Given the risk of problems associated with systemic administration, the topical application should be considered, provided stability and efficacy are assured. After nanoencapsulation, active ingredients-loaded nanosystems have been showing remarkable features of biocompatibility, healing process hastening, angiogenesis, and extracellular matrix compounds synthesis stimulation, contributing to a decrease in wound inflammation. Despite limitations, nanotechnology has attracted widespread attention in the scientific community and seems to be a valuable technological ally in the treatment and dressing of diabetic wounds. The use of nanotechnology in topical applications enables efficient delivery of the active ingredients to the specific skin site, increasing their bioavailability, stability, and half-life time, without compromising their safety.

Nanocarriers for the topical treatment of psoriasis - pathophysiology, conventional treatments, nanotechnology, regulatory and toxicology.

Psoriasis is a chronic inflammatory non-contagious disease normally characterized by a multisystemic inflammation with reddish plaques and whitish scales with greater incidence in the knees, feet and hands, elbow, scalp, and sacral areas. The global incidence of psoriasis rounds about 2% of the population and it is established that the pathophysiology of this skin disease is quite complex and still misunderstood. Nowadays, this pathology still has no cure, however, efforts are being made to find more effective and safe treatments as well as trying to decrease the occurrence of crises and complications. Nanotechnology is increasingly becoming an innovating and promising new approach for the study of various dermatological diseases, such as psoriasis. In this case, the interest in the use of nanocarriers arises in order to decrease the side effects associated with conventional therapy, as well as improve its effectiveness. Nanotechnology allows for better solubility and better delivery of the drugs, as well as an increase in their tolerance. Besides psoriasis pathophysiology and its conventional treatments, this manuscript will also be present and discusse nanotechnological strategies for topical application that intend to increase the effectiveness of treatment, as well as its regulatory and toxicological context. Regulatory issues as well as nanotoxicological concerns and long-term safeness, both for the user and for the environment will be discussed.