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

Shell-model study of β+\beta^+/EC-decay half-lives for Z=21−30Z = 21-30 nuclei

In the present work, we have reported $\beta^+$/EC-decay half-lives for $Z = 21 -30$ nuclei using large-scale shell-model. %and N $\leq$ A recent study shows that some proton-rich nuclei in this region belong to the island of inversion. We have performed calculations for these nuclei using KB3G effective interaction, while for Ni, Cu, and Zn nuclei we have used JUN45 effective interaction in the $f_{5/2}pg_{9/2}$ model space. The calculated quenching factors for $fp$ and $f_{5/2}pg_{9/2}$ space using KB3G and JUN45 effective interactions are also reported. Shell-model results of $\beta$-decay half-lives, excitation energies, log$ft$ values, and branching fractions are discussed and compared with the available experimental data. We have obtained a reasonable agreement with the available data.Comment: 12 pages, 4 figures, 4 Tables, The European Physical Journal A : Hadrons and Nuclei (2023

A Multivariate Based Provably Secure Certificateless Signature Scheme with Applications to the Internet of Medical Things

Over the last few years, Internet of Medical Things (IoMT) has completely transformed the healthcare industry. It is bringing out the most notable, and unprecedented impacts on human health, and has totally changed the way we look at the healthcare industry. The healthcare sector all around the globe are leapfrogging, and adopting the technology, helping in transforming drastically in a very short span of time. However, as more and more number of medical devices are being connected to IoMT, security issues like ensuring authenticity and integrity of the transmitted data are also on the rise. In view of the context, there is a need of an efficient cryptographic primitive that can address these issues in a viable manner. A signature scheme seems to be the natural choice to mitigate the security concerns. But, traditional signature schemes, both PKI-based and Identity-based have their own disadvantages which makes them unsuitable for IoMT networks. Thus, to address the security issues and problems like certificate management and key escrow, herein, we put forward the {\em first} multivariate based certificateless signature scheme, namely {\sf Mul-CLS}, which is built on top of the intractability of multivariate-quadratic (MQ) problem. The fact that multivariate public key cryptosystem (MPKC) provides fast, post-quantum safe, and efficient primitives, makes it a front runner candidate among the other post-quantum cryptography candidates. Our scheme {\sf Mul-CLS} provides existential unforgeability against chosen message and chosen identity Super Type I and Super Type II adversary if solving the MQ problem is NP-hard. In addition to that, our proposed {\sf Mul-CLS} presents itself as a robust and cost-friendly cryptographic building block for building IoMT networks