Author byline as per print journal: Aijing Zhang, PhD, Associate Professor Jung-Ying Tzeng, Professor Shein-Chung Chow, PhD Abstract: When an innovative biological product goes off-patent, biopharmaceutical or biotechnological companies may file an application for regulatory approval of biosimilar products. In practice, however, important information on the innovative (reference) product may not be available for assessment. Thus,…

biosimilarity, biosimilarity index, highly similar, reference standards, replicate reference study

DOI: 10.5639/gabij.2013.0204.050

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 P Shah6, PhD Abstract: The 3rd International Symposium on Scientific and Regulatory Advances in Biological and Non-Biological Complex Drugs: A to Z in Bioequivalence (3rd…

Author(s): Beat Flühmann, PhD, Daan JA Crommelin, Imre Klebovich, Jon SB de Vlieger, PhD, Professor Stefan Mühlebach, PhD, Vinod P Shah, PhD

biological medicinal products, equivalence, nanomedicines, NBCD similar approach, non-biological complex drug (NBCD)

DOI: 10.5639/gabij.2019.0803.016

Author byline as per print journal: Frank Mueller, MSc, Manal Moussa, MSc, Maria El Ghazaly, MSc, Jan Rohde, PhD, Nicole Bartsch, MSc, Antje Parthier, PhD, Frank Kensy, Dr Ing Background: Osteoporosis is a bone disease of the elderly that leads to increased risk of fracture. Currently, it affects more than 200 million adults worldwide, placing…

Author(s): et al., Frank Mueller, MSc

fermentation, hansenula polymorpha, parathyroid hormone fragment, recombinant protein, rPTH 1-34

DOI: 10.5639/gabij.2013.0203.035

Abstract: Some years ago, Australian regulatory authorities decided to follow the path laid down by the European Medicines Agency in adopting a process for approval of biosimilars. This has been a largely successful process, resulting in the licensing of biosimilars for many peptides, especially epoetin and granulocyte colony-stimulating factor (G-CSF). Aside from the availability of…

Author(s): Professor David A Power, MD, PhD, FRCP, FRACP

Australia, biosimilars, pharmaceutical benefits scheme, TGA

DOI: 10.5639/gabij.2013.0203.030

Abstract: New regulations for the development of biosimilars have been introduced in Europe and a new class of biosimilars – monoclonal antibodies – is expected on the market soon, which will both challenge and benefit our healthcare systems. Submitted: 3 June 2013; Revised: 16 July 2013; Accepted: 23 July 2013; Published online first: 5 August…

Author(s): Professor Andrea Laslop, MD

biosimilars, comparability, extrapolation, monoclonal antibodies, switching

DOI: 10.5639/gabij.2013.0203.034

Author byline as per print journal: Michael Sarshad, BSc, MBA; Rosanne Campbell, BComm, PGdip, MSc; Peter J Pitts, BA; Jacqueline anderpuye- Orgle, MSc, PhD Abstract: As the number of biosimilar product approvals continues to grow, it will become even more important to collect pharmacovigilance data that are accurate and attributable to the specific product. Different…

Author(s): Jacqueline Vanderpuye-Orgle, MSc, PhD, Michael Sarshad, BSc, MBA, Rosanne Campbell, BComm, PGdip, MSc, Peter J Pitts, BA

biosimilars, Inflectra, International Nonproprietary Name (INN), naming, nomenclature, Zarxio

DOI: 10.5639/gabij.2018.0704.031

Abstract: Chemotherapy-induced anaemia can be treated using erythropoiesis-stimulating agents (ESAs), but these can cause serious side-effects including tumour progression, venous thromboembolism, and shorter survival. Following extensive review of recent literature, the American Society of Clinical Oncology and the American Society of Hematology have updated their guidelines on the use of ESAs. New recommendations include minimising…

Author(s): GaBI Journal Editor

chemotherapy-induced anaemia, darbopoetin, epoetin, erythropoetin-stimulating agents, haemoglobin, thromboembolism

DOI: 10.5639/gabij.2013.0202.018

Author byline as per print journal: Mario R Sampson, PharmD; Michael Cohen-Wolkowiez, MD, PhD; Professor Daniel Kelly Benjamin Jr, MD, MPH, PhD; Edmund V Capparelli, PharmD; Kevin M Watt, MD Introduction: Childhood obesity is common and results in substantial morbidity. The most commonly prescribed drugs in obese children are antibiotics. However, physiological changes associated with…

Author(s): et al., Mario R Sampson, PharmD

antimicrobial agents, obesity, paediatric, pharmacokinetics

DOI: 10.5639/gabij.2013.0202.025

Abstract: The lack of clear regulatory guidance remains a key bottleneck for securing a second quality-assured source of liposomal amphotericin B (LAmB), the WHO-recommended drug for visceral leishmaniasis. The approval of the first generic liposomal product by the US Food and Drug Administration in February 2013 could be a turning point, and serve as a…

Author(s): Barbara Milani, Sara Gaspani

drug access, generics, liposomal amphotericin B, liposomal doxorubicin, visceral leishmaniasis

DOI: 10.5639/gabij.2013.0202.022

Abstract: In 2010, the Council of the European Society for Organ Transplantation formed an Advisory Committee to formulate recommendations on the use of generic drugs in solid organ transplant recipients. The initiative was taken as a result of concerns regarding generic substitution of immunosuppressive drugs. The recommendations were published in Transplant International, and this paper…

Author(s): Professor Teun van Gelder, MD, PhD

ciclosporin, generics substitution, immunosuppression, mycophenolate, tacrolimus, transplantation

DOI: 10.5639/gabij.2013.0203.031

Author byline as per print journal: Tobias Blank, PhD, Tilo Netzer, PhD, Wolfram Hildebrandt, MSc, MA, Angela Vogt-Eisele, PhD, Professor Marietta Kaszkin-Bettag, PhD Background: As patents for biological drugs begin to expire, the need for scientific guidance on biosimilar drugs grows increasingly important. The European Medicines Agency provided the first guidelines to cover the approval…

Author(s): Angela Vogt-Eisele, PhD, Professor Marietta Kaszkin-Bettag, PhD, Tilo Netzer, PhD, Wolfram Hildebrandt, MSc, MA, Tobias Blank, PhD

biosimilar regulation, biosimilar safety (EU USA), biosimilar toxicity, immunogenicity, pharmacovigilance, traceability

DOI: 10.5639/gabij.2013.0203.039

Abstract: In Japan, biosimilars guidelines following the principles of the EU framework were established by Japan’s Ministry of Health, Labor and Welfare in March 2009. The guidelines cover the manufacturing process, characterization of quality attributes, and clinical and non-clinical studies for biosimilars. In this paper, the requirements for regulatory approval of biosimilars in Japan are…

Author(s): GaBI Journal Editor

biosimilar, Japan, regulatory

DOI: 10.5639/gabij.2013.0204.055