Comparative Physicochemical and Biological Characterisation of the Similar Biological Medicinal Product Teriparatide and Its Reference Medicinal Product.

BACKGROUND: In January 2017, the European Commission approved Terrosa® (company code RGB-10) as one of the first biosimilar medicinal products of teriparatide for the same indications as for the reference medicinal product Forsteo® (Lilly France S.A.S.), which has been on the market in the European Union since 2003. The active pharmaceutical ingredient of the reference medicinal product is the biologically active 1-34 fragment of the endogenous human parathyroid hormone [PTH(1-34)]. It is one of the three bone anabolic agents used in the treatment of osteoporosis promoting bone formation and preventing fragility fractures. OBJECTIVE: The objective of this paper is to summarise the results of the comparative analysis of representative batches of both the RGB-10 drug product and the reference medicinal product performed by physicochemical and in vitro biological methods. METHODS: A series of state-of-the-art analytical methods were applied in a comparative head-to-head manner for testing the similarity in respect to purity, content, structure and potency. RESULTS: Based on the results of the comprehensive physicochemical and biological characterisation, RGB-10 proved to be highly similar to the reference medicinal product with respect to the critical quality attributes investigated. CONCLUSION: The results of the quality comparability study demonstrated similarity of RGB-10 to the reference medicinal product, providing the scientific basis for conducting a specifically designed clinical programme, and supported registration of the Marketing Authorisation Application of RGB-10 in the EU.

Quitting activity and use of cessation assistance reported by smokers in eight European countries: Findings from the EUREST-PLUS ITC Europe Surveys.

INTRODUCTION: There is clear evidence that the use of cessation aids significantly increases the likelihood of successful smoking cessation. The aim of this study was to examine quitting activity and use of cessation aids among smokers from various European countries. Subgroup differences were also examined for sex, income, education, and age in each country. METHODS: Cross-sectional data were collected in 2016 from 10,683 smokers in eight European countries participating in the ITC Project: England (n=3,536), Germany (n=1,003), Greece (n=1,000), Hungary (n=1,000), the Netherlands (n=1,136), Poland (n=1,006), Romania (n=1,001), and Spain (n=1,001). We measured quitting activity, including quit attempts in the previous 12 months and intention to quit, use of cessation aids (i.e., medication, quitlines, internet, local services, and e-cigarettes), and whether respondents had received advice about quitting and e-cigarettes from health professionals. RESULTS: Quit attempts were most common in England (46.3%) and least common in Hungary (10.4%). Quit intention was highest in England and lowest in Greece. Use of e-cigarettes to quit was highest in England (51.6%) and lowest in Spain (5.0%). Use of cessation aids was generally low across all countries; in particular this was true for quitlines, internet-based support, and local services. Receiving health professional advice to quit was highest in Romania (56.5%), and lowest in Poland (20.8%); few smokers received advice about e-cigarettes from health professionals. No clear differences were found for sex and income groups. Across countries, smokers with lower education reported less quitting activity. CONCLUSIONS: Quitting activity and use of cessation methods were low in most countries. Greater quit attempts and use of cessation aids were found in England, where large investments in tobacco control and smoking cessation have been made. Health professionals are important for motivating smokers to quit and promoting the effectiveness of various methods, but overall, few smokers get advice to quit.

The purchase sources of and price paid for cigarettes in six European countries: Findings from the EUREST-PLUS ITC Europe Surveys.

INTRODUCTION: Tobacco tax policies have been proven to be effective in reducing tobacco consumption, but their impact can be mitigated through price-minimizing behaviours among smokers. This study explored the purchase sources of tobacco products and the price paid for tobacco products in six EU member states. METHODS: Data from Wave 1 of the EUREST-PLUS ITC Europe Survey collected from nationally representative samples of adult smokers in Germany, Greece, Hungary, Poland, Romania and Spain (ITC 6E Survey) were used. The ITC 6E Survey sample, conducted in 2016, randomly sampled 6011 adult cigarette smokers aged 18 years or older. Information on purchase sources of tobacco was examined by country. The difference in reported purchase price by purchase location (store vs non-store/other) was analysed using linear regression for each country. RESULTS: Tobacco purchasing patterns and sources varied widely between countries. Non-store/other purchases were very rare in Hungary (0.1%) while these types of purchases were more common in Germany (5.1%) and Poland (8.6%). Reported prices of one standard pack of 20 cigarettes were highest in Germany (4.80€) and lowest in Hungary (2.45€). While non-store purchases were only made by a minority of smokers (>10% in all countries), the price differential was considerable between store and non-store/other sources, up to 2€ per pack in Greece and in Germany. CONCLUSIONS: The results suggest a huge variation of purchasing sources and price differentials between store and non-store purchasing sources across the six EU member states examined. While the cross-sectional data precludes any causal inference, supply chain control through licensing as introduced in Hungary and the lack of such measures in the other countries might nevertheless be a plausible explanation for the large differences in the frequency of non-store purchases observed in this study.