Public biotech 2009—the numbers

Huggett, Brady; Hodgson, John; Lähteenmäki, Riku

doi:10.1038/nbt0810-793

Cited by 13 publications

(7 citation statements)

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“…In 2012, worldwide sales of the top three selling TNFα inhibitors (TNFi) reached US$20 billion,13 with total annual sales for rheumatic disorders approaching US$30 billion per year. This amounts to a US$10 000–30 000 per patient per year financial burden to patients or third-party payers of healthcare.…”

Section: Rationale For the Development Of Biosimilarsmentioning

confidence: 99%

The role of biosimilars in the treatment of rheumatic diseases

et al. 2012

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The first biological therapeutics in rheumatology are approaching patent expiration, encouraging development of 'follow-on' versions, known as 'biosimilars'. Biological agents range from simple replacement hormones to complex monoclonal antibodies and soluble receptors: large, intricate proteins with unique tertiary and quaternary structures that are inherently difficult to replicate. Post-translational modifications, such as glycosylation, may occur from changes in cell lines and/or manufacturing processes, resulting in products that are highly similar, but not identical, to approved 'reference' agents, hence, the term 'biosimilar', rather than 'bioidentical'. Even minor modifications in manufacturing processes, which iteratively occur with reference products due to improvements in efficiency, scale up to meet commercial demands or changes in manufacturing sites, may alter biological function and/or immunogenicity, potentially changing their safety and efficacy profile. As biosimilars are now in randomised controlled trials for treatment of rheumatic diseases, rheumatologists face decisions regarding equipoise and will need to consider their clinical use versus reference products. A clear understanding of the inherent differences between reference antibodies and biosimilars, their clinical implications and the processes governing regulation, approval and clinical use of biosimilars, is paramount. A panel of international experts in the field of rheumatology recently convened to evaluate and discuss these issues.

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Section: Rationale For the Development Of Biosimilarsmentioning

confidence: 99%

The role of biosimilars in the treatment of rheumatic diseases

et al. 2012

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“…R&D at nearly all pharmaceutical companies now includes substantial biotechnology commitments. Of the ~$118 billion dedicated to all pharmaceutical and biopharmaceutical R&D in 2009, biotechnology R&D comprised ~$20 billion (estimated) by pharmaceutical companies and ~$32 billion by biotechnology companies, which exceeds 40% of total R&D expenditure in dollars 15 , 16 . In addition, there has been a shift from a few leading US biotechnology companies in the early 1980s (e.g., Amgen, Biogen, Cetus, Chiron, Genentech, Genzyme, Idec, and Immunex) to more than 4,400 biotechnology companies worldwide as of 2012 (excluding Asia), of which about 598 are publicly held, according to Ernst and Young 17 .…”

Section: Biotechnology Research Financingmentioning

confidence: 99%

The Biotechnology Innovation Machine: A Source of Intelligent Biopharmaceuticals for the Pharma Industry—Mapping Biotechnology’s Success

Evens

Kaitin

2014

Clin Pharmacol Ther

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The marriage of biotechnology and the pharmaceutical industry (pharma) is predicated on an evolution in technology and product innovation. It has come as a result of advances in both the science and the business practices of the biotechnology sector in the past 30 years. Biotechnology products can be thought of as "intelligent pharmaceuticals," in that they often provide novel mechanisms of action, new approaches to disease control, higher clinical success rates, improved patient care, extended patent protection, and a significant likelihood of reimbursement. Although the first biotechnology product, insulin, was approved just 32 years ago in 1982, today there are more than 200 biotechnology products commercially available. Research has expanded to include more than 900 biotechnology products in clinical trials. Pharma is substantially engaged in both the clinical development of these products and their commercialization.

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“…Although their impact on rheumatic diseases has been remarkable, the cost of biologic therapies imposes a significant financial burden on patients and third party payors. With sales for the top three TNFis exceeding $20 billion in 2012, ranging from $10–30 000 per patient per year, this burden restricts their use to patients in wealthier countries. As patents are expiring on the first generation of biologic therapies, it is not surprising that there is considerable interest in development of effective biosimilar agents.…”

Section: Economic Rationalementioning

confidence: 99%

Biosimilars: how similar?

Strand¹,

Cronstein

2014

Internal Medicine Journal

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As patents expire on biological agents for the treatment of rheumatic diseases, we have the opportunity to develop non-proprietary biologic agents, biosimilars. The development and approval of these agents present novel challenges to both pharma and regulatory agencies although there is great promise of high quality, less expensive biologic agents for the treatment of rheumatic diseases. Here, we review the definitions of biosimilars, the regulatory challenges to approval of these agents and the record of approvals of biosimilars to date.

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Public biotech 2009—the numbers

Cited by 13 publications

References 0 publications

The role of biosimilars in the treatment of rheumatic diseases

The role of biosimilars in the treatment of rheumatic diseases

The Biotechnology Innovation Machine: A Source of Intelligent Biopharmaceuticals for the Pharma Industry—Mapping Biotechnology’s Success

Biosimilars: how similar?

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