Abstract: CT-P13 was the first infliximab biosimilar approved in Brazil. Approval was granted for all indications of the innovator. Despite similar efficacy and safety, vigilance remains essential. Submitted: 4 January 2016; Revised: 27 January 2016; Accepted: 1 February 2016; Published online first: 12 February 2016 On 27 April 2015, the Brazilian Health Surveillance Agency (Agência […]
Abstract: Biosimilars have been approved in Europe since 2006. With patents on originator biologicals expiring and ever-tightening healthcare budgets biosimilars are likely to take an increasing share of the biologicals market. In light of these facts, this article gives estimated patent expiry dates for just some of the best-selling biologicals. Submitted: 19 November 2015; Revised: […]
Author byline as per print journal: Michael S Reilly, Esq; Harry L Gewanter, MD, FAAP, FACR Introduction: World Health Organization (WHO) recommendations for the regulation of biosimilars form the basis of guidelines used across most of Latin America. However, the pace at which the region moves toward reaching its potential of having safe and effective biosimilars […]
Abstract: As per regulatory requirements, biosimilar drugs must show high similarity to their reference product in quality, preclinical and clinical tests. It is by these means that biosimilars are considered to be safe and efficacious. In India, any major deviation(s) from science-based principles in the manufacturing of a recombinant DNA-derived therapeutic biological product leads to […]
Abstract: This paper discusses topics covered by the EGA’s April 2015 biosimilars conference, where extrapolation of indications was highlighted as a key issue. Submitted: 2 July 2015; Revised: 15 July 2015; Accepted: 15 July 2015; Published online first: 28 July 2015 The European Generic medicines Association (EGA) held its 13th EGA–European Biosimilars Group Conference in […]
Abstract: The substantial improvement in the power of analytical methods to compare different versions of a given protein molecule should be taken into account when considering the value of clinical studies for designation of biosimilarity. Arguably, demonstration of comparative pharmacokinetic, allied to post-registration monitoring, will provide more discriminatory clinical evidence than large pre-approval therapeutic equivalence […]
Abstract: How to improve the uptake of biosimilars is a question that many countries are finding a challenge. Researchers from the Madrid Health Service investigate how initiatives in Spain have affected biosimilars use. Submitted: 24 March 2016; Revised: 12 May 2016; Accepted: 19 May 2016; Published online first: 1 June 2016 As is the case […]
Abstract: Biosimilars should be approved for all the clinical indications of the reference product based on the totality of the evidence even if there is no clinical safety and efficacy data for each indication. The foundation of biosimilar development is the demonstration that chemical, physical and biological parameters are highly similar to the reference product. […]
Abstract: With a number of patents on biological medicines soon to expire in the US, multiple stakeholders – from policymakers to manufacturers to payers – have been debating the structure of regulatory frameworks and in particular, naming conventions for biosimilars. A key area of concern has been the potential impact of naming, and specifically, whether […]
Abstract: Over the last few years, there has been a shift in the landscape of blockbuster medicines from small molecule drugs to biologicals. While small molecule drugs still dominate the global pharmaceutical market in terms of numbers, seven of the top 10 best-selling medicines in 2018 were biologicals. The high and rising cost of biologicals […]
Abstract: Regulations for biosimilars in the Republic of Korea have been in place since 2009. Since then, the country has also put in place specific guidelines and approved four biosimilars. Submitted: 18 December 2014; Revised: 23 February 2015; Accepted: 9 March 2015; Published online first: 20 March 2015 The legislative basis for the regulation of […]
Abstract: Notwithstanding the scientific and regulatory differences between generic and biosimilar medicines, the European Medicines Agency/Committee for Medicinal Products for Human Use has consistently applied a ‘same active substance’ approach to both. Submitted: 28 November 2014; Revised: 20 January 2015; Accepted: 27 January 2015; Published online first: 30 January 2015 It is often stated that […]
