Abstract: Despite the fact that US Food and Drug Administration has yet to receive a biosimilars application, many US states have been considering legislation which could potentially limit biosimilars substitution. The Biologics Price Competition and Innovation Act (BPCI Act) of 2009 was signed into law on 23 March 2010 by President Barack Obama. The BPCI…

Author(s): GaBI Journal Editor

biologicals, biosimilars substitution, state legislation

DOI: 10.5639/gabij.2013.0203.040

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

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

Author byline as per print journal: Andrew Mica, MBA, Martha Mutomba, PhD, Larry Green, PharmD Introduction: When drug shortages occur, healthcare providers (HCPs) often must ration drugs, cancel or delay treatments, or utilize alternative drugs that may be less efficacious and/or are associated with increased risk of adverse outcomes, potentially impacting patient care. The likelihood…

Author(s): Andrew Mica, MBA, et al.

biological, drug shortages, healthcare provider, manufacturing, supply chain

DOI: 10.5639/gabij.2013.0203.038

Author byline as per print journal: Shih-Ting Chiu, PhD, Chen Chen, MSc, Professor Shein-Chung Chow, PhD, Eric Chi, PhD Introduction: For generic approval of small-molecule (chemical) drug products, US Food and Drug Administration requires evidence of equivalence in average bioavailability from bioavailability and bioequivalence studies. To address drug interchangeability, population bioequivalence (PBE) for drug prescribability…

Author(s): et al., Shih-Ting Chiu, MSc

extra-reference design, generalized pivotal quantity, individual bioequivalence, replicated crossover design

DOI: 10.5639/gabij.2013.0203.037

Author byline as per print journal: Alessandro Curto, MSSc, Katelijne Van de Vooren, MSc, Roberta Lo Muto, MSc, Silvy Duranti, MBA, Professor Livio Garattini Introduction: Health care in Italy is mainly delivered through the country’s National Health Service (NHS), a public service funded by general taxation. The system is highly decentralized and each one of…

Author(s): Alessandro Curto, MSSc, Katelijne Van de Vooren, MSc, Professor Livio Garattini, Roberta Lo Muto, MSc, Silvy Duranti, MBA

biosimilars, competition, Italy, regions, tender

DOI: 10.5639/gabij.2013.0203.036

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: Dr Brian Godman reviews the paper by Markovic-Pekovic et al. regarding recent reforms in the Republic of Srpska. These include prescribing restrictions where concerns with the value of products and measures to obtain low prices for generics, which is important given the rhetoric. Submitted: 11 June 2013; Revised: 13 June 2013; Accepted: 17 June…

Author(s): Brian Godman, BSc, PhD

demand-side measures, generics, renin-angiotensin inhibitor drugs, Srpska, statins, supply-side measures

DOI: 10.5639/gabij.2013.0203.029

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

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

Abstract: The AIFA’s position paper recognizes the relevance of biosimilars to ensure the sustainability of drug expenditure but the new price and reimbursement procedure may not favour their prompt market access. Submitted: 26 June 2013; Revised: 10 July 2013; Accepted: 11 July 2013; Published online first: 24 July 2013 In the final position paper on…

Author(s): Gianluigi Casadei, MD

AIFA, biosimilars, market access, position paper, pricing, reimbursement

DOI: 10.5639/gabij.2013.0203.033

Editor's Letter

Published on 30 September 2013

Latest features in GaBI Journal, 2013, Issue 3

The GaBI Journal again contains manuscripts covering a wide range of pertinent topics. In an Editorial, Dr Gianluigi Casadei reviews Italy’s final position paper on biosimilars including the new price and reimbursement position from the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA). Dr Casadei questions how much of a ‘step forward’ as well as…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2013.0203.032