New FDA requirements for generics trials

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New FDA requirements for generics trials

INICIO/Políticas y legislación | Posted 16/08/2013 0 Post your comment

As of January 2014 generics companies may be required to submit data for not just one batch, as is currently the case, but for three batches.

Although this is already the case for generics submitted to Europe, where EMA already requires safety, efficacy and stability data from three batches of any new generic drug, the change are expected to increase the costs of generics development by up to three times.

Additional requirements for extended studies of generic drugs are also being proposed by FDA, which will require new generics to be kept in real time conditions for 36 months.

The increased costs are being attributed mainly to the cost of the active ingredient – the greater the number of batches the greater more active ingredient is required. The total cost of generic drug development is estimated at around US$3 million per product.

Indian drugmakers such as Cadila Health, Dr Reddy’s Laboratories, Lupin, Ranbaxy and Sun Pharma each file around 15–20 abbreviated new drug applications (ANDAs) per year seeking approval from FDA. Smaller Indian generics companies such as Torrent Pharma and Alembic still file five to 10 ANDAs per year with FDA.

Despite the increased costs that may result from these additional requirements the US is a major market for Indian companies and is sure to remain a lucrative one. The US generics market is estimated to be worth around US$30 billion, of which Indian pharmaceutical companies account for 10% market share at US$3–3.5 billion.

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Source: Business Standard