Biosimilar Insulins

Heinemann, Lutz; Hompesch, Marcus

doi:10.1177/1932296813516958

Cited by 29 publications

(14 citation statements)

References 12 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Only now, with intellectual property (i.e., patents) for many insulin analogues having recently expired or expiring soon [19], have biosimilar insulin analogues been marketed. However, there is still no inexpensive supply of insulin biosimilars for people living with diabetes in North America, and Americans are paying a steep price for the 'continued rejuvenation' of this medicine [10].…”

Section: Insulin Is a Prohibitively Expensive Essential Medicinementioning

confidence: 99%

“…Meanwhile, at least 11 insulin biosimilars are marketed (under less stringent regulatory frameworks) at considerably lower price points in China, India, Mexico, Pakistan, Peru, and Thailand [20]. Studies comparing a handful of these biosimilars to innovator insulins showed no meaningful differences [19,20].…”

Section: Insulin Is a Prohibitively Expensive Essential Medicinementioning

confidence: 99%

“…Due to the size and complexity of biologics and the sensitivity of their manufacturing processes, achieving consistency is a major challenge. Impurities, altered structural stabilities, and differing patterns of glycosylation [19] can all potentially alter immunogenicity. Safety and therapeutic efficacy must be demonstrated using animal toxicology data, pharmacokinetics, pharmacodynamics, and most expensively for the applicant, Phase 1 and likely Phase 3 human clinical trials.…”

Section: Obstacles For 'Biohacked' Insulin: Regulationmentioning

confidence: 99%

See 2 more Smart Citations

The Open Insulin Project: A Case Study for ‘Biohacked’ Medicines

Gallegos

Boyer²,

Pauwels

et al. 2018

Trends in Biotechnology

View full text Add to dashboard Cite

New innovation ecosystems are emerging that challenge the complex intellectual property and regulatory landscape surrounding drug development in the United States (US). A prime example is an initiative known as the Open Insulin Project. The goal of the project is to sidestep patents and enable generic manufacturers to produce cheaper insulin. However, the US regulatory environment, not patent exclusivity, is the main barrier to insulin affordability. If the Open Insulin Project succeeds in releasing an open protocol for insulin manufacturing, follow-on work could enable a number of new insulin production ecosystems, including 'home-brewed' insulin. Regulators will need to consider how to proceed in a future where commercial pharmaceuticals remain unaffordable, but patients are empowered to produce drugs for their personal use.

show abstract

Section: Insulin Is a Prohibitively Expensive Essential Medicinementioning

confidence: 99%

Section: Insulin Is a Prohibitively Expensive Essential Medicinementioning

confidence: 99%

Section: Obstacles For 'Biohacked' Insulin: Regulationmentioning

confidence: 99%

See 1 more Smart Citation

The Open Insulin Project: A Case Study for ‘Biohacked’ Medicines

Gallegos

Boyer²,

Pauwels

et al. 2018

Trends in Biotechnology

View full text Add to dashboard Cite

show abstract

“…2). The manufacturing processes are proprietary, and different manufacturers use different processes, increasing the potential for structural differences between biologicals 9, 10.…”

Section: Manufacture Of Biological Drugs As Source Of Variabilitymentioning

confidence: 99%

Introduction of biosimilar insulins in Europe

et al. 2017

View full text Add to dashboard Cite

Regulatory approval of the first biosimilar insulin in Europe, LY2963016 insulin glargine (Abasaglar®), in 2014 expanded the treatment options available to people with diabetes. As biosimilar insulin products come to market, it is important to recognize that insulin products are biologicals manufactured through complex biotechnology processes, and thus biosimilar insulins cannot be considered identical to their reference products. Strict regulatory guidelines adopted by authorities in Europe, the USA and some other countries help to ensure that efficacy and safety profiles of biosimilar insulins are not meaningfully different from those of the reference products, preventing entry of biological compounds not meeting quality standards and potentially affecting people's glycaemic outcomes. This review explains the concept of biosimilar medicines and outlines regulatory requirements for registration of biosimilar insulins in Europe, which is illustrated by the successful development of LY2963016 insulin glargine and MK‐1293 insulin glargine (Lusduna®). Preclinical and clinical comparative studies of the biosimilar insulin glargine programmes include in vitro bioassays for insulin and insulin‐like growth factor 1 receptor binding, assessment of in vitro biological activity, evaluation of pharmacokinetic/pharmacodynamic profiles in phase I studies and assessment of long‐term safety and efficacy in phase III studies. The emergence of biosimilar insulins may help broaden access to modern insulins, increase individualized treatment options and reduce costs of insulin therapy.

show abstract

“…It is evident then, that as more biosimilar insulins come to market, independent studies of batch‐to‐batch variability, and if possible clinical correlates, are desirable 10, 12.…”

Section: Manufacturing and Batch‐to‐batch Variabilitymentioning

confidence: 99%

Biosimilar insulins: guidance for data interpretation by clinicians and users

Heinemann¹,

Home

Hompesch

2015

Diabetes Obesity Metabolism

View full text Add to dashboard Cite

Biosimilar insulins are approved copies of insulins outside patent protection. Advantages may include greater market competition and potential cost reduction, but clinicians and users lack a clear perspective on ‘biosimilarity’ for insulins. The manufacturing processes for biosimilar insulins are manufacturer‐specific and, although these are reviewed by regulators there are few public data available to allow independent assessment or review of issues such as intrinsic quality or batch‐to‐batch variation. Preclinical measures used to assess biosimilarity, such as tissue and cellular studies of metabolic activity, physico‐chemical stability and animal studies of pharmacodynamics, pharmacokinetics and immunogenicity may be insufficiently sensitive to differences, and are often not formally published. Pharmacokinetic and pharmacodynamic studies (glucose clamps) with humans, although core assessments, have problems of precision which are relevant for accurate insulin dosing. Studies that assess clinical efficacy and safety and device compatibility are limited by current outcome measures, such as glycated haemoblobin levels and hypoglycaemia, which are insensitive to differences between insulins. To address these issues, we suggest that all comparative data are put in the public domain, and that systematic clinical studies are performed to address batch‐to‐batch variability, delivery devices, interchangeability in practice and long‐term efficacy and safety. Despite these challenges biosimilar insulins are a welcome addition to diabetes therapy and, with a transparent approach, should provide useful benefit to insulin users.

show abstract

Biosimilar Insulins

Cited by 29 publications

References 12 publications

The Open Insulin Project: A Case Study for ‘Biohacked’ Medicines

The Open Insulin Project: A Case Study for ‘Biohacked’ Medicines

Introduction of biosimilar insulins in Europe

Biosimilar insulins: guidance for data interpretation by clinicians and users

Contact Info

Product

Resources

About