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.

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.

Cosmetic products have been increasingly regulated, particularly in Europe. With the introduction of the cosmetic regulation in 2013, stricter quality standards were implemented, surpassing those set by the 1976 legislation. The primary objective of these regulations is to safeguard consumer safety during the use of cosmetic products. Despite these advancements, certain regulatory gaps remain, indicating the need for more effective measures to enhance human and environmental health protection. Considering the aforementioned, this work aims to provide an overview of the current Cosmetics Regulation, highlighting the weakest cornerstones that represent the missing link keeping the core objective from being achieved. While there is ongoing reliance on historical data from animal studies, efforts are actively underway to replace these methods with new new approach methodologies for risk assessment. Additionally, regulatory authorities continue to improve environmental considerations in the assessment process. These measures, along with enhanced surveillance systems, are gradually addressing existing gaps and contributing to a more robust regulatory framework that balances market access with consumer safety. Legally non-compliant—or perhaps compliant but unknowingly dangerous—products may be used by people who relativize them as inherently safe, leading to adverse events. Whether caused by an underlying disease or purely by the chemical’s toxicity, these may never come to the attention of the authorities as they are generally under-reported, making it unfeasible to implement corrective or preventive measures to address their root cause. To illustrate, non-compliant products that have been detected by the Portuguese authority, INFARMED, I. P., from January 2018 to September 2023 are discussed, which were found to be potentially dangerous to human health and, therefore, withdrawn from the market.

Resveratrol is a polyphenolic phytoalexin, whose main natural sources are red grapes, red wine, berries, and peanuts. When applied to the skin, resveratrol evidences a good penetrating capacity and low degradation compared to the oral route, allowing for a longer and improved topical effect. This bioactive molecule has been gaining interest in dermo-pharmacy and cosmetics for the prevention and treatment of skin alterations. Its inherent meritorious biomedical potentials, including anti-aging, photoprotective, estrogen-like, skin-whitening, anti-acne, wound healing, anti-scarring, antimicrobial, and anti-skin cancer properties are the most evident. However, resveratrol evidences stability hurdles, becoming an unstable molecule when exposed to ultraviolet radiation. Several technological strategies have been developed to improve its stability, efficacy, and safety. We have described the main topical properties of resveratrol, and the involved mechanisms of action, and a great focus was placed on the technological strategies for the efficient application of resveratrol in dermatological and cosmetic formulations, including nanotechnology.

The wine industry is responsible for a considerable amount of waste produced by agricultural activities worldwide, which impacts both the economic sector and the environment through pollution and ecosystem imbalance. There are several examples of by-products generated during the winemaking process, such as grape pomace, vine leaves, grape stalks, or wine lees. These can be recovered and reused by the cosmetic industry, which is actively seeking natural and greener products. There are active ingredients that come from by-products that have relevant bioactive properties such as antioxidant, antiaging, anti-hyperpigmentation, or cellular protection. Therefore, the use of by-products from the wine industry as a source of active ingredients for topical application has attracted attention from the scientific community, overcoming some of the drawbacks of the winemaking process. Further research into extraction processes and methods is essential, as they directly influence the quality and quantity of recovered active ingredients. While current cosmetic products on the market undergo safety and cytotoxicity testing, it is important to evaluate the effects of pesticide treatments applied before pruning and the toxicity of the by-products to ensure the safety of future formulations. This review addresses a critical discussion on this subject, assessing the potential benefits of their use in topical formulations. Graphical Abstract

Background: Ganoderma lucidum (GL), commonly known as the “Lingzhi” or “Reishi” mushroom, has long been recognized for its potential health benefits and medicinal properties in traditional Chinese medicine. The unique potential combination of bioactive compounds present in GL, such as triterpenoids, polysaccharides, and peptides, has inspired interest in leveraging their therapeutic potential In recent years, the emerging field of nanotechnology has opened up new possibilities for using the remarkable properties of GL at the nanoscale. Objetive: The main objective of this review is to explore the unique potential of GL in traditional and innovative therapies, particularly in cancer treatment, and to assess how nanotechnology-based strategies can enhance its therapeutic applications.is to explore. Results: Nanotechnology-based strategies have been investigated for the efficient extraction and purification of bioactive compounds from GL. Additionally, nanocarriers and nanoformulations have been developed to protect these sensitive bioactive compounds from degradation, ensuring their stability during storage and transportation. The use of GL-based nanomaterials has shown promising results in several biomedical applications, namely due to their anticancer activity by targeting cancer cells, inducing apoptosis, and inhibiting tumor growth. Conclusions: The combination of GL and nanotechnology presents an exciting frontier in the development of novel therapeutic and biomedical applications. Nevertheless, further research and development in this interdisciplinary field are warranted to fully exploit the synergistic benefits offered by GL and nanotechnology. Future prospects include the development of robust clinical trials focused on GL nanotechnology-based cancer therapies to clarify mechanisms of actions and optimize formulations, ultimately leading to innovative solutions for human health and well-being.