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’.
The alloy was chosen in order to obtain a shape memory alloy having a wider hysteresis than equiatomic NiTi, that involves a better thermo-mechanical stability. Two samples investigated by differential scanning calorimetry (DSC) were previously annealed at 800oC/12 h and, respectively, 900 �C/12 h followed by furnace cooling. These were afterwards submitted to thermal cycling. The thermal cycling of a Ni50Ti48Nb2 alloy sample previously annealed at 900 �C/12 h results in lower critical points and higher hysteresis values as compared to those of the sample annealed at 800�C/12h, also submitted to thermal cycling. Thus, annealing a metallic part made of such an alloy at 900� C/12 h followed by thermal cycling prior to putting it into service enhances its reliability.
Aluminium bronzes are exhibiting good corrosion resistance in saline environments combined with high mechanical properties. Their corrosion resistance is obviously confered by the alloy chemical composition, but it can also be improved by heat treatment structural changes. In the present paper, five Cu-Al-Fe-Mn bronze samples were subjected to annealing heat treatments with furnace cooling, water quenching and water quenching followed by tempering at three different temperatures: 200, 400 and 550�C. The heating temperature on annealing and quenching was 900�C. The structure of the heat treated samples was studied by optical and scanning electron microscopy. Subsequently, the five samples were submitted to corrosion tests. The best resistance to galvanic corrosion was showed by the quenched sample, but it can be said that all samples are characterized by close values of open-circuit potentials and corrosion potentials. Concerning the susceptibility to other types of corrosion (selective leaching, pitting, crevice corrosion), the best corrosion resistant structure consists of a solid solution, g2 and k compounds, corresponding to the quenched and 550�C tempered sample.
The present paper is focused on three different aging treatment of a TiNi alloy in order to enhance corrosion resistance in oral cavity environment. The best corrosion resistance in artificial saliva after aging treatment was found in the case of sample which was heat treated at 700 °C/20 min/water cooled, followed by aging at 400 °C/1.5 h/water cooled. Subsequent to such a heat treatment, the EDX surface analysis indicated an increase of Ti content of the matrix. This effect is in connection with stable and metastable precipitates which appear during the aging. Also, based on the greater affinity to oxygen of Ti compared to Ni, a uniform Ti based oxide layer is predominant explaining the better electrochemical stability. The obtained precipitates morphology is also an important factor in the corrosion behavior.
The paper presents microstructural features of three stainless steels utilized in making hydropower turbine parts. Two of these steels were already used in producing these parts, the third one is newly conceived. Aiming better mechanical and corrosion resistance characteristics, steels were produced using an induction furnace with cold crucible under vacuum and argon atmosphere, striving for an inclusion � free state. Quenching and tempering heat treatments were subsequently applied. The microstructural investigations, carried-out by microhardess testing, optical and scanning electron microscopy (SEM) associated with energy dispersive spectrometry (EDS), were able to explain the structural modifications. Refined microstructures were found in the two first steels. Concerning the third one, a precipitation phenomenon of intermetallic compounds such as Ni3(Ti,Mo) was reported, similar to that encountered in the maraging steels class. Mechanical properties of this steel are very different from classic martensitic stainless steels ones. Specifically, after tempering the hardness values do not decrease as in other steels, but increase about 1.6 times. Thus a new steel category with duplex properties is reported.
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