Abstract: : The Opinion published in this issue of GaBI Journal titled ‘Biosimilars drug development: time for a paradigm shift'’ by Sandeep N Athalye, Shivani Mittra, and Ankitkumar M Ranpur proposes a number of changes to the regulatory processes currently in place for biosimilars. This response letter considers the implications and consequences of these. Subscribe now to GaBI … PubDate: Thu, 05 Jan 2023 13:24:59 +000
Abstract: Author byline as per print journal: Sandeep N Athalye, MS; Shivani Mittra, MPharm, PhD; Ankitkumar M Ranpura, MD : The sky-rocketing cost of developing biosimilars is becoming a shared deterrent for biosimilar developers. The regulatory requirements for biosimilars must see a natural evolution and a paradigm shift towards removing inefficiencies in clinical designs to make way … PubDate: Thu, 05 Jan 2023 13:14:47 +000
Abstract: Author byline as per print journal: Chuei Wuei Leong, PhD; Elton Sagim, BBiomedSc, Kar Ming Yee, BPharm; Muhammad Shalhadi Saharuddin, BSc; Sharifah Radziah Syed Abd Rahim, MSc; Khairil Sabri, BSc; Mohd Zulhairi Jamaluddin, BSc; Shahnun Ahmad, MBBS; Atiqah Amran1, BSc; Rabab F Tayyem, PhD, Malaysia Study Objectives: The present study aimed to evaluate the comparative bioavailability … PubDate: Thu, 05 Jan 2023 13:08:06 +000
Abstract: Contents Editor’s Letter The importance of trust Original Research Social trust and regional variation in the adoption of biosimilars in Italy and Germany US prescribers’ attitudes and perceptions about biosimilars Review Article Development of Ph. Eur. standards for therapeutic monoclonal antibodies: infliximab case study Meeting Report Key factors for successful uptake of biosimilars: Europe and the US PubDate: Tue, 03 Jan 2023 15:45:19 +000
Abstract: It seems as if the entire world is dealing with a lack of trust, even in many things that have enriched and sustained human development, including our neighbours, teachers, the press, corporations, politicians, religious leaders, scientists, academic institutions, governments, and even the basic concepts of democracy. Lack of trust is posing a direct threat to … PubDate: Thu, 29 Dec 2022 10:42:26 +000
Abstract: Contents Editor’s Letter What to look forward to in GaBI Journal, 2022, Issue 2 Commentary Substitution and interchangeability: time for a conversation' Original Research On statistical evaluation for interchangeability of biosimilar products A case study of AstraZeneca’s omeprazole/esomeprazole chiral switch strategy Review Article Manufacture and regulation of cell, tissue and gene therapy products: global perspectives, … PubDate: Tue, 29 Nov 2022 09:43:59 +000
Abstract: The editors and publisher wish to express their gratitude to the colleagues listed below for their valuable contribution to the peer review process for the Generics and Biosimilars Initiative Journal (GaBI Journal) in 2021. Dr Chiann Chang, Brazil Associate Professor Dr Devrim Demir Dora, Turkey Dr Thijs J Giezen, The Netherlands Dr Weng Fai Lai, Singapore Dr … PubDate: Tue, 29 Nov 2022 09:36:13 +000
Abstract: Keywords: Monoclonal antibodies, pharmacopoeia, infliximab, public standards, flexibility Author byline as per print journal: M Buda, PhD : This article describes the European Pharmacopoeia exploratory study on infliximab as a test case for developing public standards for monoclonal antibodies. The design and outcome of the feasibility study, importance of interaction with stakeholders and the challenges and lessons … PubDate: Mon, 26 Sep 2022 10:53:35 +000
Abstract: Author byline as per print journal: James C. Robinson, PhD, MPH Introduction/Study Objectives: Adoption of biosimilars has fallen below projections, despite the vigorous implementation of economic incentives, thereby highlighting the importance of behavioral factors such as social trust. This paper analyzes biosimilar adoption across provinces in Italy and Germany, which evince strong variation in social trust, … PubDate: Thu, 08 Sep 2022 13:31:04 +000
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