BIOSIMILARS: OPPORTUNITIES, CHALLENGES, AND THE GENERAL PRINCIPLES GOVERNING THEIR DEVELOPMENT AROUND THE GLOBE

Biologic drugs have revolutionized the treatment of many life-threatening and rare illnesses such as cancer and autoimmune diseases. Biologics are broadly referred as substances that are produced by living cells and are used in the treatment, prevention, or diagnosis of diseases. They include a wide range of substances, such as genetic material, antibodies, vaccines, or processes which act by influencing cellular processes that block disease or affect diseased cells. Biologics have become striking treatment options and the size of the market has grown hastily. It is expected that by 2023, most of the patents will expire in the European Union opening a large potential market. Keeping this in mind, the ability to launch substitutes to original biologics, also known as biosimilars, presents many opportunities to generic companies. The field of biosimilars seems to be “breaking” the traditional division between the creations of innovative NCE-based medicines by research-based companies, on the one hand, and, on the other hand, mapping of these medicines by the generic companies. The field of biosimilars so far presents some considerable challenges, namely, regulatory, safety, economic, and legal which are still being debated and discussed in different forums. In this article, we have tried to summarize the general principles and regulations governing the development of biosimilars by regulatory authorities such as the World Health Organization, European Medicines Agency, US Food and Drug Administration, and Health Canada. Furthermore, we have tried to throw some light on the opportunities, challenges, and current scenarios pertaining to biosimilars

Oral Health Promotion: Evidences and Strategies

Oral health promotion is for upliftment of oral health of community rather than an individual and has long‐term impact. Since Ottawa Charter for health promotion is implemented, significant advancements have happened in oral health promotion. Under comprehensive health programs, India has been running oral health promotion programs, and these evidences are shared here. Such examples are apt learning and execution to any part of world having similarities. The chapter put forward the strategic view points to consider further oral health promotion aspects and based on the needs. The authors have gathered various examples from national programs implemented in India. The authors discuss how these programs are linked to the Oral health promotion concept. For example, National tobacco control program which currently running across many states in India, how the banning on tobacco products near school premises helped to reduce the incidence is discussed. The worldwide literature and evidences of oral health promotion strategies are explained. The evidences and strategies mentioned can be significant for another region of world. Unless published, many programs remain hidden and are loss of valuable evidences to oral health science

Royalty Rates and Non-Disclosure Agreements in SEP Licensing: Implications for Competition Law

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Pictorial essay: Orbital tuberculosis

Tuberculosis of the orbit is rare, even in places where tuberculosis is endemic. The disease may involve soft tissue, the lacrimal gland, or the periosteum or bones of the orbital wall. Intracranial extension, in the form of extradural abscess, and infratemporal fossa extension has been described. This pictorial essay illustrates the imaging findings of nine histopathologically confirmed cases of orbital tuberculosis. All these patients responded to antituberculous treatment

Pictorial essay: Orbital tuberculosis

Tuberculosis of the orbit is rare, even in places where tuberculosis is endemic. The disease may involve soft tissue, the lacrimal gland, or the periosteum or bones of the orbital wall. Intracranial extension, in the form of extradural abscess, and infratemporal fossa extension has been described. This pictorial essay illustrates the imaging findings of nine histopathologically confirmed cases of orbital tuberculosis. All these patients responded to antituberculous treatment