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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.

Immunogenicity of biosimilar low molecular weight heparins

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].

Timing of the launch of biosimilars in Europe

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].

Challenges ahead for biosimilar development

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.