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How profitable will biosimilars be

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].

US$54 billion worth of biosimilar patents expiring before 2020

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].

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

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].

EMA biosimilar regulation should include complex biologicals

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].

The biosimilars landscape

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].

EMA comparability studies limiting biosimilar success

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].

The market for global and European biosimilars

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].

Biosimilars and the pharmaceutical industry

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.

Development of biosimilars

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

Standards for biosimilars or ‘alternative’ biologicals in India

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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