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 out for trastuzumab biosimilars. Submitted: 26 March 2020; Revised: 2 April 2020; Accepted: 2 April 2020; Published online first: 15 April 2020 Roche’s originator trastuzumab […]
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 pressure on healthcare budgets, thus opening the door to biosimilars. With patents on originator biologicals expiring, biosimilars are expected to take an increasing share of […]
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 and biosimilars makers and could be delaying access to life-saving treatments. Submitted: 5 December 2017; Revised: 7 December 2017; Accepted: 8 December 2017; Published online […]
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 latest available clinical experiences with biosimilar medicines, focusing on switching between biological medicines and interchangeability. Assistant Professor Gianluca Trifirò from the University of Messina, Italy, […]
Abstract: Comments from physician associations on the US Food and Drug Administration’s draft guidance on interchangeability of biosimilars are presented in this paper.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 the comments on extrapolation, interchangeability, switching, labelling and naming, post-marketing and disease experts. Submitted: 2 June 2017; Revised: 13 June 2017; Accepted: 13 June 2017; […]
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 possibly delay access to life-saving treatments. Submitted: 6 April 2017; Revised: 14 April 2017; Accepted: 14 April 2017; Published online first: 28 April 2017 There […]
Abstract: Biosimilars have been approved in Europe since 2006 and in the US since 2015. With patents on originator biologicals expiring and ever-tightening healthcare budgets, biosimilars are expected to take an increasing share of the biologicals market. In light of these facts, this paper gives estimated patent expiry dates for just some of the best-selling […]
Author byline as per print journal: Subramanian Venkatesan, MSc; Associate Professor Martine Lamfers, PhD; Professor Sieger Leenstra, MD, PhD; Professor Arnold G Vulto, PharmD, PhD, FCP Abstract: Kinase inhibitors form the largest class of novel anticancer drugs. To date, more than 20 kinase inhibitors have been approved for clinical use. Lengthy patent rights keep the cost […]
Abstract: European Pharmacopoeia (Ph. Eur.) monographs for biotherapeutic products have existed since the 1990s and remain the publicly available standard defining the quality of these medicines. Continued development of such monographs however faces considerable challenges in the current environment. This manuscript addresses what the main challenges are (complexity of biologicals, setting of specifications, relations with […]
Abstract: A study of the factors influencing generics makers’ decision on whether to enter a specific market found that firm size, market revenue and expected competition all had an effect. Market size was also positively associated with the entry of more generics. The effect of a financial subsidy on generics entry was also investigated. Submitted: […]
Abstract: There is considerable concern and debate over the naming of biologicals and labelling of biosimilars. To ensure that patients receive the safest and most effective treatment, it is paramount that clinicians, prescribers and patients themselves have the relevant information regarding drug treatment. In response to concerns over how biologicals and biosimilars should be named […]
Abstract: Pharmacopoeias, as standard references for pharmaceutical drug specifi cations and reference standards in the form of monographs, play a pivotal role to assure drug quality and safety. With emphasis on the activities concerning non-biological complex drugs (NBCDs), the mechanisms by which new monographs are introduced into the European and the US pharmacopoeias are presented. […]
