Sulfonitrocarburizing of High-Speed Steel Cutting Tools: Kinetics and Performances.

The scholarly literature records information related to the performance increase of the cutting tools covered by the superficial layers formed "in situ" when applying thermochemical processing. In this context, information is frequently reported on the carbamide role in processes aiming carbon and nitrogen surface saturation. Sulfur, together with these elements adsorbed and diffused in the cutting tools superficial layers, undoubtedly ensures an increase of their operating sustainability. The present paper discusses the process of sulfonitrocarburizing in pulverulent solid media of high-speed tools steel (AISI T1, HS18-0-1) and its consequences. The peculiarity of the considered process is that the source of nitrogen and carbon is mainly carbamide (CON2H4), which is found in solid powdery mixtures together with components that do not lead to cyan complex formation (non-toxic media), and the sulfur source is native sulfur. The kinetics of the sulfonitrocarburizing process, depending on the carbamide proportion in the powdered solid mixture and the processing temperature, was studied. The consequences of the achieved sulfonitrocarburized layers on the cutting tools' performance are expressed by the maximum permissible cutting speed and the maximum cut length. An interesting aspect is highlighted, namely the possibility of using chemically active mixtures. Their components, by initiation of the metallothermic reduction reaction, become able to provide both elements of interest and the amount of heat needed for the ultrafast saturation of the targeted metal surfaces.

The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA.

Biosimilar medicines expand the biotherapeutic market and improve patient access. This work looked into the landscape of the European and US biosimilar products, their regulatory authorization, market availability, and clinical evaluation undergone prior to the regulatory approval. European Medicines Agency (EMEA, currently EMA) and Food and Drug Administration (FDA) repositories were searched to identify all biosimilar medicines approved before December 2019. Adalimumab biosimilars, and particularly their clinical evaluations, were used as a case study. In the past 13 years, the EMA has received 65 marketing authorization applications for biosimilar medicines with 55 approved biosimilars available in the EU market. Since the first biosimilar approval in 2015, the FDA has granted 26 approvals for biosimilars with only 11 being currently on the US market. Five adalimumab biosimilars have been approved in the EU and commercialized as eight different medicines through duplicate marketing authorizations. Whilst three of these are FDA-approved, the first adalimumab biosimilar will not be marketed in the US until 2023 due to Humira's exclusivity period. The EU biosimilar market has developed faster than its US counterpart, as the latter is probably challenged by a series of patents and exclusivity periods protecting the bio-originator medicines, an issue addressed by the US's latest 'Biosimilar Action Plan'.