Special Report
Physicochemical stability of Doxorubicin Accord 2 mg/mL in punctured original vials and polypropylene syringes and after dilution with 0.9% sodium chloride or 5% glucose solution in polyethylene bottles
Page: 62-4
Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To determine the physicochemical stability of Doxorubicin Accord 2 mg/mL concentrate in original… Read More »
Extended stability data on small molecule anticancer medicinal products – anything new? any additional information necessary?
Author(s): Irene Krämer, PhD, Judith Thiesen, PhD
Page: 61, 70
Abstract: Monoclonal antibodies and cell therapies play an increasingly significant role in anticancer therapy, but small molecules remain an essential part of combination chemotherapy. Despite the publication of many studies… Read More »
Follow-on biologicals/biosimilars approved in Brazil: May 2023 update
Author(s): Sílvia Helena Cestari de Oliveira, MSc
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
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
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
Author(s): Beat Flühmann, PhD, Daan JA Crommelin, Imre Klebovich, Jon SB de Vlieger, PhD, Professor Stefan Mühlebach, PhD, Vinod P Shah, PhD
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: 2018 update
Author(s): GaBI Journal Editor, GaBI Online Editor
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 »
Patent expiry dates for biologicals: 2017 update
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
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
Author(s): Assistant Professor Gianluca Trifirò, MD, PhD
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 »