Submitted: 30 January 2018; Revised: 8 February 2018; Accepted: 12 February 2018; Published online first: 26 February 2018 The past year has once again been a busy one for the biosimilars industry. Important milestones achieved during 2017 were the biosimilar approvals of Renflexis (infliximab-abda), Cyltezo (adalimumab-adbm), Mvasi (bevacizumab-awwb), Ixifi (infliximab-qbtx) and Ogivri (trastuzumab-dkst), along with […]
Submitted: 27 January 2017; Revised: 31 January 2017; Accepted: 1 February 2017; Published online first: 6 February 2017 Previous years have been momentous for biosimilars [1] and 2016 is no exception. This paper highlights the various developments that have taken place during 2016 for biosimilars. Important milestones achieved during 2016 were the biosimilar approvals of […]
Submitted: 24 May 2016; Revised: 8 June 2016; Accepted: 10 June 2016; Published online first: 24 June 2016 The introduction of biologicals has revolutionized the treatment of immune-mediated diseases such as rheumatoid arthritis (RA) [1]. However, in many countries, patient access to these agents is restricted due to their high costs [2, 3]. Biosimilar drugs […]
Submitted: 24 May 2016; Revised: 8 June 2016; Accepted: 10 June 2016; Published online first: 24 June 2016 CT-P13, also known by its brand names Remsima or Inflectra, is a biosimilar of the infliximab reference product (RP) Remicade. CT-P13 is approved in Europe, the US and elsewhere for use in all indications for which the […]
Submitted: 14 January 2016; Revised: 26 January 2016; Accepted: 27 January 2016; Published online first: 9 February 2016 Once again the biosimilars industry has had a busy year [1]. Perhaps the most important milestone achieved during 2015 was the landmark decision made by the US Food and Drug Administration (FDA) on 6 March 2015 to […]
Submitted: 10 February 2015; Revised: 24 February 2015; Accepted: 25 February 2015; Published online first: 6 March 2015 The past year has once again been a busy one for the biosimilars industry. One of the most important milestones during 2014 was the news that the US Food and Drug Administration (FDA) had accepted several biosimilars […]
The world market for medicinal products is expected to reach US$1 trillion in 2014. Global spending on medicines is expected to grow to nearly US$1.2 trillion by 2017 [1]. As governments around the world try to rein in healthcare expenses, generics and biosimilars can play a major role in reducing this budgetary burden. Intellectual property […]
Results of a survey carried out by the European Crohn’s and Colitis Organisation (ECCO) highlight a lack of confidence in biosimilars and the need for continued education. The results of the ECCO 2013 survey [1] were presented by Dr Alessandro Armuzzi, together with the EU physician 2013 survey on naming, transparency and traceability for biosimilars […]
Submitted: 2 March 2014; Revised: 7 March 2014; Accepted: 8 March 2014; Published online first: 21 March 2014 The guideline ‘Note for guidance on modified release oral and transdermal dosage forms: Section II (Pharmacokinetic and clinical evaluation)’ [1] was issued over 10 years ago, and the need for revision was recognized in 2010. An international […]
The International Alliance of Patients’ Organizations (IAPO) is an alliance of over 200 patient groups that represents the interests of patients worldwide. In November 2013, IAPO published its Information and Advocacy Toolkit on Biological and Biosimilar Medicines for Patients’ Organizations [1]. The Toolkit was developed to provide up-to-date, evidence-based information on the science, technology, and […]
The past year has been a busy one for the biosimilars industry. Perhaps one of the most important milestones during 2013 was the European approval of the first monoclonal antibody biosimilar [Remsima/Inflectra (infliximab)] made as a collaboration by South Korean biotechnology company Celltrion and US-based generics major Hospira [1]. Celltrion has also gained approval for […]
There have been established guidelines for approving generic versions of small molecule chemical drugs in India for some time already. However, no specific guidelines for ‘similar biologics’, as the Indian regulatory authorities call these products, have existed in India until recently. This has been the case despite the fact that the requirements for granting regulatory […]
