Opinion

Overview of non-innovator biological products in India

Published in: Volume 9 / Year 2020 / Issue 1
Author(s):
Page: 30-6

Abstract: As per regulatory requirements, biosimilar drugs must show high similarity to their reference product in quality, preclinical and clinical tests. It is by these means that biosimilars are considered… Read More »

Why ‘similar’ can make a big difference

Published in: Volume 8 / Year 2019 / Issue 3
Author(s):
Page: 132

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… Read More »

Rationalizing FDA guidance on biosimilars—expediting approvals and acceptance

Published in: Volume 7 / Year 2018 / Issue 2
Author(s):
Page: 84-91

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… Read More »

Austrian medicines authority positive towards biosimilar interchangeability

Published in: Volume 6 / Year 2017 / Issue 1
Author(s):
Page: 41

Abstract: Clinical evidence supporting biosimilar use is growing and for the first time, the Austrian Medicines and Medical Devices Agency takes a positive position on interchangeability. They now state that… Read More »

Where does the value of ‘value-added’ pharmaceuticals come from?

Published in: Volume 5 / Year 2016 / Issue 4
Author(s):
Page: 171-3

Abstract: The role of sound science, discovery, and innovation in value-added pharmaceuticals has not been sufficiently considered. This term is mainly used to define improved version of generic drugs. The… Read More »

Challenges of developing generics substitution policies in low- and middle-income countries (LMICs)

Published in: Volume 4 / Year 2015 / Issue 4
Author(s): ,
Page: 171-2

Abstract: There are few challenges to developing effective generics substitution policies in low- and middle-income countries (LMICs). These include the absence of generics substitution policies, lack of enforcement, lack of… Read More »

Is Australia positioned to take advantage of biosimilars?

Published in: Volume 3 / Year 2014 / Issue 4
Author(s):
Page: 184-7

Abstract: Australia currently has a small generic and biosimilar medicine industry despite having a good track record in biomedical research and a sound reputation in producing high quality but small… Read More »

Tell me the whole story: the role of product labelling in building user confidence in biosimilars in Europe

Published in: Volume 3 / Year 2014 / Issue 4
Author(s):
Page: 188-92

Abstract: The European Medicines Agency (EMA) has led the development of biosimilar regulatory pathways globally, tailoring their approach to meet the specific and scientifically determined needs of biosimilar development. However,… Read More »

Pathway to affordable, quality-assured sources of pegylated interferon alpha for treating hepatitis C

Published in: Volume 2 / Year 2013 / Issue 4
Author(s): ,
Page: 194-203

Author byline as per print journal: Barbara Milan, Sara Gaspani Introduction: The current pipeline of promising oral hepatitis C drugs could lead to a revolution in treatment for this disease… Read More »

Biosimilarity is not a transitive property: implication for interchangeability, naming and pharmacovigilance

Published in: Volume 11 / Year 2022 / Issue 1
Author(s):

Abstract: Current regulations do not require a given biosimilar to remain similar to its reference biological over time. However, two products that were initially deemed biosimilar or interchangeable could each… Read More »

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