UK to open up biosimilar drugs market with change to rules

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A change in the rules for approval of so-called biosimilar copycat drugs will save the NHS millions and help patients get treated sooner, it was claimed today.

Biosmilars are used to replicate the performance of biologics – the complex combination of proteins used to treat conditions such as arthritis.

As biologics are derived from living organism, copying them is harder than for chemical-based drugs where a generic formula is just repeated. Instead, they are regarded as highly similar and do much the same thing.

However, the need for a biosimilar version of biologic drugs to undergo clinical trials in patients has now been removed by UK regulator the Medicines and Healthcare Agency (MHRA).  

“Removing these unnecessary confirmatory clinical trials opens up the possibility of more conditions being treated with biosimilar medicines and could save the NHS hundreds of millions of pounds,” Mark Samuels, chief executive of the British Biosimilars Association, told The Telegraph.

Around 80% of the most expensive drugs used by the NHS are biologics, he added, and using biosimilars as an alternative would save the health service millions.

Abbvie‘s Humira, a biologic and up until recently the world’s biggest earning drug, was one of the NHS’s biggest drug expenditures but is now costing the health service £300mln a year less due to the use of a biosimilar alternative now that it is off-patent.

Lucentis, one of the main treatments for age-related degenerative blindness, is another where huge savings are expected.

Dr Siu Ping Lam, director of licensing at the MHRA, said: “The UK seeks to be a global leader in the development and authorisation of biosimilar products and aims to remain an attractive market to launch biosimilar products into.”

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