Several biopharmaceuticals, including insulin and insulin analogs, are, or shortly will be, off-patent, thereby providing an opportunity for companies to attempt to manufacture "copies" commonly referred to as biosimilars and also known as follow-on biologics. Reassurance that such copy biologics are equally safe and effective as the conventional products is essential. It is important for the clinician to consider what information is therefore necessary for such assurances. Biopharmaceuticals, produced from living organisms and manufactured by complex processes, differ in many respects from chemically derived drugs. The biological source materials and manufacturing processes for non-innovator biologics may differ considerably from those used for producing the innovator substance. Differences between innovator and non-innovator products can be identified analytically (e.g., batch-to-batch consistency, product stability along side clinical safety). This provides a strong argument for caution before automatic substitution of conventional products (e.g., insulin by biosimilars). Several non-innovator insulins, including insulin analogs (while still patent-protected), are already available in many countries. Many of these lack rigorous regulations for biosimilar approval and pharmacovigilance. Recently an application for a biosimilar recombinant human insulin was withdrawn by the European Medicines Agency because of safety and efficacy concerns. Therefore, every biosimilar insulin and insulin analog should be assessed by well-defined globally harmonized preclinical and clinical studies followed by post-marketing pharmacovigilance programs, in the interest of people with diabetes worldwide.

This study examined the effects of daily parental autonomy support on changes in child behavior, family environment, and parental well‐being across 3 weeks during the COVID‐19 pandemic in Germany. Day‐to‐day associations among autonomy‐supportive parenting, parental need fulfillment, and child well‐being were also assessed. Parents (longitudinal N = 469; M age = 42.93, SD age = 6.40) of school children (6–19 years) reported on adjustment measures at two measurement occasions and completed up to 21 daily online questionnaires in the weeks between these assessments. Results from dynamic structural equation models suggested reciprocal positive relations among autonomy‐supportive parenting and parental need fulfillment. Daily parental autonomy support, parental need fulfillment, and child well‐being partially predicted change in adjustment measures highlighting the central role of daily parenting for children’s adjustment during the pandemic.

Objective: When confronted with major threats, people often experience decline in well-being. The central purpose of this study was to identify mechanisms underlying change of well-being in times of threat, using the example of the COVID-19 pandemic, with a focus on appraisals of the pandemic and affective states, stress, as well as mindfulness in daily life. Method: We conducted a study across 3.5 weeks, including pretest, posttest, and a diary phase in-between. We worked with a sample of 460 adults, pre-and post-test information, as well as 7,189 observations from the diary phase. Results: Results showed that deterioration in mental health symptoms across the duration of the study was associated with (a) change towards less fortunate appraisals of the pandemic and (b), more negative affect and less mindfulness in daily life. Furthermore, appraisals of the pandemic at pretest predicted experiences in daily life, with more negative appraisals of the pandemic predicting more negative affect and stressor occurrence as well as less mindfulness. Conclusions: These findings speak to the dynamic nature of well-being and appraisals in times of threat, and highlight the role of experiences in daily life in changes in well-being.

a. M., Germany Author Note The SASCHA study is a project at the IDeA (Individual Development and Adaptive Education of Children at Risk) Center in Frankfurt am Main, Germany, and is funded by the German Research Foundation (DFG; Deutsche Forschungsgemeinschaft; Grant SCHM 2411/9-1). Hypotheses and analyses of Study 3 of the present work were preregistered (https://osf.io/uywbr). We preregistered Study 3 based on results of Study 1 and before the start of Study 2. We applied the preregistration (e.g., measures, hypotheses, analyses) to all three studies presented in the current work.

Two intensive longitudinal studies examining the association between children's feeling of relatedness to peers at school and their affective well-being were performed. In Study 1, 110 third and fourth graders reported on their positive affect (PA) and negative affect (NA) 4 times daily and on their peer relatedness once a day over 4 weeks. Multilevel analyses revealed that children who reported higher peer relatedness on average also reported higher PA and lower NA (between-person associations). Moreover, on days when children reported higher peer relatedness than usual, they also reported higher PA, but they did not necessarily report lower NA (within-person associations). In Study 2, 55 fourth, fifth, and sixth graders indicated their PA, NA, and peer relatedness once a day over 2 weeks. We replicated the findings of Study 1 on both levels. The studies showed that feeling related to peers is associated with high PA at school and at home on a daily basis, illustrating the function of peer relatedness in promoting positive well-being. The findings further demonstrated the necessity of intensive longitudinal studies focusing on within-person associationsThis is an open access article under the terms of the Creat ive Commo ns Attri butio n-NonCo mmercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

To slow down the spread of the COVID-19 virus, schools around the world were closed in early 2020, transferring children's scholastic activities to the homes and imposing a massive burden on parents and school-age children. Using data of a 21-day diary study conducted between March and April 2020 in Germany, this work examined whether (a) distance learning and (b) parents' involvement therein were associated with negative parent-child interactions and affective well-being of parents and children, over and above the effect of daily stressors. Participants were 562 parents (489 mothers, M age = 42.79, SD age = 6.12, range = 25-63) most of whom were married (n = 382, 68.0%). They responded to the daily items with respect to the youngest child living in their household (M age = 9.74, SD age = 2.81, range = 6-19). On days when children were working on school tasks, parents reported more negative parent-child interactions as well as lower parental and child positive affect and higher child negative affect, but not higher parental negative affect. Moreover, days when parents were more heavily involved in learning (i.e., when children worked less independently) were days with more negative parent-child interactions, lower parental and child positive affect, and higher parental and child negative affect. Negative parent-child interactions were linked to lower affective well-being of parents and children, and partially accounted for the relation among daily stressors and affective well-being. The present work highlights the need for measures to better support school-age children and their parents during distance learning.

As a means to counter the SARS-CoV‑2 pandemic, schools were closed throughout Germany between mid-March and end of April 2020. Schooling was translocated to the students’ homes where students were supposed to work on learning tasks provided by their teachers. Students’ self-regulation and attributes of the learning tasks may be assumed to have played important roles when adapting to this novel schooling situation. They may be predicted to have influenced students’ daily self-regulation and hence the independence with which they worked on learning tasks. The present work investigated the role of students’ trait self-regulation as well as task difficulty and task enjoyment for students’ daily independence from their parents in learning during the homeschooling period. Data on children’s trait self-regulation were obtained through a baseline questionnaire filled in by the parents of 535 children (Mage = 9.69, SDage = 2.80). Parents additionally reported about the daily task difficulty, task enjoyment, and students’ learning independence through 21 consecutive daily online questionnaires. The results showed students’ trait self-regulation to be positively associated with their daily learning independence. Additionally, students’ daily learning independence was shown to be negatively associated with task difficulty and positively with task enjoyment. The findings are discussed with regard to students’ daily self-regulation during the homeschooling period. Finally, implications for teaching practice during the pandemic-related school closures are derived.

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