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Biosimilars/Research

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Can biosimilar manufacturers learn from generic substitution issues

Biosimilars/Research | Posted 04/11/2011

The substitution of generic prescription medicines for branded medicines is practiced in most Westernised countries, mainly because of its clear economic benefits. Patient experiences of generic substitution are mixed however, with many patients left confused or suspicious [1]. Given that a number of second-generation biosimilar compounds are expected to be approved within the next few years, and that biosimilar manufacturing costs are much higher than those of a simple generic, it is crucial for biosimilar manufacturers to avoid the uncertainty and mistrust that often accompanies generic substitution. Several recommendations have been made to help ensure that substitution pathways are streamlined and successful [1] but can any of these recommendations be applied to biosimilars?

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US biosimilars: a report on FDA progress

Biosimilars/Research | Posted 04/11/2011

This article reviews the steps being taken by FDA to implement the Biologics Price Competition and Innovation (BPCI) Act of 2009, enshrined in law in 2010 as the ‘biosimilars statute’.

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Development of biosimilars is not an easy matter

Biosimilars/Research | Posted 28/10/2011

By 2020 biological products with sales of around US$23 billion in the EU and US$29 billion in the US will be exposed to biosimilar competition [1]. As more and more biologicals lose their patent protection, it is no wonder that Big Pharma, the biotechnology industry and generics manufacturers, as well as regulatory agencies, are becoming increasingly interested in biosimilars [2].

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US biosimilars law may prove a barrier to entry for biosimilars

Biosimilars/Research | Posted 23/09/2011

One of the main barriers to biosimilar entry in the US is the US biosimilars law [1]. While some have questioned whether the biosimilars pathway in the US will ever be used [2, 3], others believe that, although flawed, the US biosimilars pathway is likely to become a functioning legal pathway [4].

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Brand-name statins costing healthcare system US$6.7 billion

Biosimilars/Research | Posted 21/10/2011

Researchers at Mount Sinai School of Medicine, New York, USA, found that physicians prescribing unnecessary treatments or diagnostic tests, spanning a broad range of clinical conditions, costs the US healthcare system an extra US$6.7 billion annually. The findings, published in Archives of Internal Medicine, attributed prescribing of brand-name statins instead of generic statins as accounting for most of the excess cost [1].

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Biotech pipeline and biosimilars

Biosimilars/Research | Posted 14/10/2011

There are more than 200 new biotechnology products in the pipeline (phase II to registered), all of which could be future targets for biosimilars. However, around 60% of these products concern mechanisms of action that are already available, see Figure 1 [1].

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Biosimilars or biobetters–what does the future hold

Biosimilars/Research | Posted 14/10/2011

Biosuperiors or biobetters are improvements to originator biological molecules, whereas biosimilars are structural imitations of the originator. But how will the pharma industry choose to pursue this lucrative market and benefit from patent expirations on biologicals? Will biobetters or biosimilars be the winners?

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How profitable will biosimilars be

Biosimilars/Research | Posted 07/10/2011

The profitability of biosimilars remains an open question. Five years after launch it is thought that most biosimilars markets will look similar to generics markets (70% penetration, 25% of brand-name drug price) but also that a ‘brand-like’ market with lower price attrition and market share is possible [1].

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US$54 billion worth of biosimilar patents expiring before 2020

Biosimilars/Research | Posted 30/09/2011

By 2020 biological products with sales of around US$23 billion in the EU and US$29 billion in the US are expected to be exposed to biosimilar competition [1].

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Biosimilars: barriers to entry and profitability in the EU and US

Biosimilars/Research | Posted 16/09/2011

The implications of the US biosimilars law and the pending patent expiries of the 12 major biological products in the EU and the US will have an impact on the profitability and viability of the biosimilars industry [1].

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EMA biosimilar regulation should include complex biologicals

Biosimilars/Research | Posted 23/09/2011

The EMA’s comprehensive biosimilar regulatory pathway, which includes the need for new clinical trials and comparability studies that demonstrate quality, efficacy, and safety, should be expanded to include complex biologicals, according to innovation researchers at Utrecht University, Utrecht, The Netherlands [1].

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The biosimilars landscape

Biosimilars/Research | Posted 23/09/2011

There is obviously a market for biosimilars. This is driven by the cost savings to be made by payers and patients alike. By 2015, IMS Health (IMS) expects spending on biosimilars to exceed US$2 billion annually, or about 1% of total global spending on biologicals. They expect new biosimilars to enter the US market by 2014 and European markets to have additional biosimilar molecules introduced during this period [1].

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EMA comparability studies limiting biosimilar success

Biosimilars/Research | Posted 16/09/2011

The EMA’s comprehensive biosimilar regulatory pathway, which includes the need for new clinical trials and comparability studies that demonstrate quality, efficacy, and safety, is a barrier for the development of clinically superior compounds, according to innovation researchers at Utrecht University, Utrecht, The Netherlands [1].

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The market for global and European biosimilars

Biosimilars/Research | Posted 16/09/2011

Due to expiring patents for brand name products, cheaper generics are expected to grab market share [1]. This is not surprising due to the list of blockbuster drugs losing their patent protection in 2011 and 2012. These include the world’s best-selling drug, Lipitor (atorvastatin), which in 2010 had almost US$13 billion in worldwide sales, accounting for 15.8% of Pfizer’s total revenue [2].

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Biosimilars and the pharmaceutical industry

Biosimilars/Research | Posted 09/09/2011

IMS Health predicts a slowing down of the growth in annual spending on medicines, with generics being one of the main contributing factors for this reduction.

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Development of biosimilars

Biosimilars/Research | Posted 01/07/2011

Costs and risk reduction are facilitating product development of biosimilars [1].

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Standards for biosimilars or ‘alternative’ biologicals in India

Biosimilars/Research | Posted 10/06/2011

In the highly regulated market of the EU clear and rigorous guidelines exist for approval of biosimilars. In the EU biosimilars must ensure the same quality, safety and efficacy, as any other product, along with demonstrating biosimilarity (comparability) with the reference product.

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Immunogenicity of biosimilar low molecular weight heparins

Biosimilars/Research | Posted 22/04/2011

In a presentation by Professor JM Walenga and colleagues from the Loyola University Medical Center, Illinois,USA, 'immunogenicity issues faced by biosimilar low molecular weight heparins (LMWHs)' were discussed [1].

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Timing of the launch of biosimilars in Europe

Biosimilars/Research | Posted 12/08/2011

When and where to launch a new biosimilar to ensure that its uptake is the most effective throughout Europe is an issue that affects all pharmaceutical companies working on biosimilars [1].

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Challenges ahead for biosimilar development

Biosimilars/Research | Posted 17/06/2011

Biosimilars, it seems are here to stay, but there is still some way to go before they become commonplace. There is also concern over the associated costs for biological medicines. The cost of biotech therapies is expected to steadily grow by about 30% (an approximately 20 fold increase in 10 years) by 2016.