Search results for biosimilars

An evolving role for non-governmental organizations dealing with registration backlogs and rising costs: the example of cancer biosimilars in South Africa

Abstract: Around the world, especially in low- and middle-income countries, national regulatory authorities are struggling with registration backlogs and the affordability of medicines. This paper draws on the example of cancer biosimilars in South Africa to illustrate how non-governmental organizations can help regulatory authorities decide which registration applications to prioritize by providing information on clinical […]

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It is time to change US trade policy to foster access to medicines

Abstract: While Americans are deeply concerned about drug prices, the United States Trade Representative (USTR) continues to negotiate agreements like the United States-Mexico-Canada Agreement (USMCA) that put at risk the sustainability of the generics industry and undermine the development of biosimilars that play a critical role in access to medicines. It is time to restore […]

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Why ‘similar’ can make a big difference

Abstract: This article explains what motivated the Digestive Cancers Europe’s (DiCE) recent position paper on biosimilar medicines for colorectal cancer. Submitted: 7 October 2019; Revised: 14 October 2019; Accepted: 15 October 2019; Published online first: 25 October 2019 Background Colorectal cancer may not be as widely known or talked about as some other types of […]

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First ASEAN educational workshop on regulation and approval of biosimilars/similar biotherapeutic products 2017 – Report

Author byline as per print journal: Robin Thorpe, PhD, FRCPath; Elwyn Griffiths, PhD, DSc; Niklas Ekman, PhD Abstract: Biosimilar medicines are being increasingly developed and used worldwide. Many regulatory agencies across the globe are assessing how policy and regulation can be adapted and developed to ensure that biosimilars can enter markets successfully, without affecting the safety […]

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Rationalizing FDA guidance on biosimilars—expediting approvals and acceptance

Abstract: Biosimilar drugs have suffered slow entrance and acceptance rates in the US market, due not only to common misperceptions among the public but also US Food and Drug Administration (FDA) licensing laws. This review offers nine major recommendations for the FDA to simplify how biosimilars are licensed and thus make biosimilars more accessible to […]

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Quality assessment of biosimilars in Colombia – reducing knowledge gaps

Abstract: Biosimilar medicines are having a global effect, and as such regulatory agencies worldwide are assessing how to respond to them. Here, two events held by GaBI for the Colombian medicines regulatory agency (INVIMA) are reported. The first was an educational workshop held in 2016 to discuss approaches to evaluating biosimilar products and the second […]

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EU Member States have tools to reduce costs of bestseller biologicals but can they use them?

Abstract: Major cost savings are achievable in pharmacotherapy in the European Union since biosimilars to most best-selling biological medicinal products have been licensed. Unfortunately, the window of opportunity may be missed since neither national pricing, reimbursement and procurement systems nor prescribers are well prepared for biosimilars’ entry to the market. Submitted: 9 March 2018; Revised: […]

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Perspectives on the future of pegfilgrastim biosimilars

Author byline as per print journal: Professor Pere Gascón, MD; Ruediger Jankowsky, PhD; Karsten Roth, PhD Abstract: Cinfa Biotech, the biosimilars specialists of the Cinfa Group, reviewed pegfilgrastim biosimilar approaches to treat chemotherapy-induced neutropenia. Professor Dr Gascón discussed ’perspectives of pegfilgrastim’ and Dr Roth and Dr Jankowsky discussed why biosimilars are vital for oncology care. Submitted: […]

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Clear naming, traceability of biological medicines will protect patients

Author byline as per print journal: Adjunct Professor Valderilio Feijó Azevedo, MD, PhD, MBA; Associate Professor Brian Bressler, MD, MS, FRCPC; Madelaine A Feldman, MD, FACR; Professor Alejandro Mercedes, MD Abstract: As more biological medicines and biosimilars become increasingly available worldwide, clear product identification is critical for accurate pharmacovigilance. Submitted: 25 September 2017; Revised: 25 September […]

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Biosimilars in Germany: guidance of the Drug Commission of the German Medical Association

Abstract: Biosimilars have been available in Europe for more than 10 years, but their adoption in Germany has not been very successful. As their pharmaceutical quality, efficacy (particularly in extrapolated indications), safety (especially immunogenicity) and interchangeability with reference products have been controversially discussed by healthcare professionals, the Drug Commission of the German Medical Association developed […]

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Pharmacy-mediated substitution of biosimilars – a global survey benchmarking country substitution policies

Introduction/Study objectives: Between March and May 2017, Pfizer conducted an internal global survey of 82 countries examining biosimilar pharmacy-mediated substitution to understand and benchmark the global policy landscape. Methods: Pfizer regulatory and corporate affairs colleagues completed a survey: Are pharmacists in your country able to substitute a biological with a biosimilar without the physician being […]

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Biosimilars in Italy: what do real-world data reveal?

Author byline as per print journal: Assistant Professor Gianluca Trifirò, MD, PhD; Ylenia Ingrasciotta, MSc; Ilaria Marcianò, MSc; Armando A Genazzani, DPhil, MD Abstract: This paper aims to provide an overview of the available real-world data about the pattern of use and the comparative effectiveness of biosimilars and originator biological drugs in Italy. Different observational studies […]

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