Author byline as per print journal: Shivani Mittra1, MPharm, PhD; Shylashree Baraskar1, MBBS; Elena Wolff -Holz2, MD; Sandeep N Athalye1, MBBS, MD Abstract: Drug development is among the highest producers of greenhouse gas (GHG) emissions, with about 4.4%–4.6% of the worldwide GHG emissions coming from the thousands of clinical trials being carried out annually by […]
Abstract: The Opinion published in this issue of GaBI Journal titled ‘Biosimilars drug development: time for a paradigm shift?’ by Sandeep N Athalye, Shivani Mittra and Ankitkumar M Ranpur proposes a number of changes to the regulatory processes currently in place for biosimilars. This response letter considers the implications and consequences of these. Submitted: 8 December […]
Author byline as per print journal: Rieke Alten1, MD, PhD; Herbert Kellner2, MD; Malcolm Boyce3, MD; Takuma Yonemura4, MD; Takahiro Ito5, MSc; Mark C Genovese6, MD Introduction/Study objectives: FKB327 is a biosimilar of the adalimumab reference product. Studies in healthy subjects and patients with rheumatoid arthritis demonstrated biosimilarity between FKB327 and the reference product in […]
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: Biologicals have offered a new avenue for targeting therapy to treat life-threatening and chronic diseases. The recent or pending patent expirations of many successful biologicals have permitted the marketing of ‘copy’ versions of the off-patent biologicals, generally known as biosimilars (subsequent entry biologics in Canada). The reduced clinical package and the potential for extrapolation […]
Abstract: The number of drug shortages in the US has tripled between 2006 and 2012, with drug shortages now affecting most US oncologists and impacting on patient care. There is a need for new guidelines to control drug substitutions and to single out priority populations for relatively scarce drugs. The very real threat of […]
