Special Report

Patent expiry dates for biologicals: 2018 update

Published in: Volume 8 / Year 2019 / Issue 1
Author(s): ,
Page: 24-31

Abstract: Over the last few years, there has been a shift in the landscape of blockbuster medicines from small molecule drugs to biologicals. While small molecule drugs still dominate the… Read More »

Follow-on biologicals/biosimilars approved in Brazil: May 2023 update

Published in: Volume 12 / Year 2023 / Issue 2
Author(s):
Page: 67-72

Abstract: Brazilian requirements for approval of biosimilars are aligned with a strict regulatory process and ensure the same high standards of quality, safety and efficacy as for originator biologicals. Submitted:… Read More »

Biosimilars markets: US and EU compared

Published in: Volume 9 / Year 2020 / Issue 2
Author(s):
Page: 90-2

Abstract: Differences between the US and European regulatory processes can lead to differences in the time taken for biosimilar approval. The European Medicines Agency is in some cases quicker to… Read More »

Clinical trials for trastuzumab biosimilars

Published in: Volume 9 / Year 2020 / Issue 2
Author(s):
Page: 84-9

Abstract: Clinical trials must demonstrate biosimilarity for regulatory marketing approval to be granted. The GaBI Journal has conducted a search for clinical trials that have been, or are being, carried… Read More »

A progress report on the 3rd International Symposium on Scientific and Regulatory Advances in Biological and Non-Biological Complex Drugs: A to Z in Bioequivalence

Published in: Volume 8 / Year 2019 / Issue 3
Author(s): , , , , ,
Page: 128-31

Author byline as per print journal: Jon SB de Vlieger1, PhD; Professor Daan JA Crommelin2, PhD; Beat Flühmann3, PhD; Professor Imre Klebovich4, PharmD, PhD, DSc; Professor Stefan Mühlebach3,5, PhD; Vinod… Read More »

Patent expiry dates for biologicals: 2017 update

Published in: Volume 7 / Year 2018 / Issue 1
Author(s):
Page: 29-34

Abstract: Although small molecule drugs still dominate the global pharmaceutical market in terms of numbers, biologicals are making a significant dent. However, the high cost of biologicals is putting increasing… Read More »

USA and Europe differ in interchangeability of biosimilars

Published in: Volume 6 / Year 2017 / Issue 4
Author(s):
Page: 183-4

Abstract: This paper highlights differences between USA and Europe when it comes to the interchangeability of biosimilars. The lack of harmonization between USA and Europe may introduce confusion for stakeholders… Read More »

Building stakeholder confidence in biosimilar medicines through evidence-based information sharing

Published in: Volume 6 / Year 2017 / Issue 4
Author(s):
Page: 181-2

Abstract: The European Commission held a stakeholder event to discuss biosimilar medicinal products in May 2017. A session on building stakeholder confidence in biosimilar medicines provided an update of the… Read More »

Physician associations comment on FDA’s interchangeability guidance

Published in: Volume 6 / Year 2017 / Issue 3
Author(s):
Page: 120-1

Abstract: Comments from physician associations on the US Food and Drug Administration’s draft guidance on interchangeability of biosimilars are presented in this paper. Various issues were discussed; this paper highlights… Read More »

Interchangeability of biosimilars in the US and around the world

Published in: Volume 6 / Year 2017 / Issue 2
Author(s):
Page: 97-8

Abstract: In this paper, differences across the world are highlighted when it comes to the interchangeability of biosimilars. The lack of harmonization makes it difficult for biosimilars makers and could… Read More »

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