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Sandoz to file for approval of aflibercept biosimilar

European Pharmaceutical Review

The confirmatory efficacy and safety study ( NCT04864834 ) demonstrated therapeutic equivalence between the biosimilar aflibercept and the reference biologic, Eylea®. Safety, immunogenicity, and pharmacokinetics results also confirmed no clinically meaningful difference between the products.

Safety 94
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Interchangeability of biosimilars in the EU – the industry impact

European Pharmaceutical Review

3 Under this pathway, comparability studies are required to substantiate the similar nature, in terms of safety and efficacy, of the biosimilar and the reference product. For this reason, a unique ‘abridged’ procedure was introduced to provide a specific regulatory pathway for biosimilars in the EU.

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How clinical outcome assessments can help us understand the patient experience

Clarivate

The purpose of clinical trials is to understand the efficacy and safety of treatments for the patients who need them. Data and insights gleaned from these projects have most recently been presented at industry conferences and events, including ISPOR.

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Bringing the patient voice into clinical trials with clinical outcome assessments

Clarivate

The purpose of clinical trials is to understand the efficacy and safety of treatments for the patients who need them. In this article, we share how a sponsor partnered with Clarivate to incorporate COAs into clinical trials for alopecia areata. The regulatory landscape around COAs is fast evolving.

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Securing every dose with an edible security technology for safe medicines

European Pharmaceutical Review

FAKE MEDICINES are not a new problem, and pose a tremendous threat to patient safety and public health in society regardless of a country’s economic status. World Health Organization; 2006. The prevalence of fake drugs is a continually growing problem worldwide. References. Counterfeit medicines. Available from: [link]. The Guardian.

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Learning from lecanemab: a breakthrough treatment

European Pharmaceutical Review

In clinical trials, we targeted the early AD population with confirmed amyloid in the brain and found the right optimal dose that balanced efficacy and safety in the large Phase II dose-ranging study. Building on these 4R’s, we designed the Phase III Clarity AD study in order to definitively assess the safety and efficacy of lecanemab.

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Sweeping changes in leaked EU pharma law draft reignite profit vs access conflict

Pharmaceutical Technology

The products that are authorised in EU are largely the same as other regions,” argued European Commission Directorate-General for Health and Food Safety Florian Schmidt, during the same online event. But others do not accept that the EU is less competitive for the pharma industry than North America and Asia. You can compare timelines.

Pharma 64