Tagged as: UK

The UK’s MHRA Updates its Guidance on Licensing of Biosimilars

On November 7, 2022, the UK’s Medicines and Healthcare Products Regulatory Agency (“MHRA”) updated its “Guidance on the licensing of biosimilar products” by expanding the criteria for achieving interchangeability between a biosimilar and reference medicinal product (“RP”).  The UK’s Guidance now recognizes that “[o]nce authorised, a biosimilar product is considered…

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Brexit’s Impact on the Biosimilar Market

The United Kingdom’s referendum in favor of withdrawal from the European Union, colloquially known as “Brexit,” has already sent shockwaves through the business world, both within the UK, and abroad.  The impact of Brexit on the pharmaceutical industry has yet to be determined, but some fear that Brexit will cause…

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NHS Releases Biosimilars Guidance, Prohibits Automatic Substitution

On September 24, 2015, the United Kingdom’s National Health Service (NHS) released a biosimilars guidance document, available here. In it, the NHS bans automatic substitution of biosimilars, meaning that pharmacists may not switch between biosimilars and reference biologics, or between one biosimilar and another, without the consent of the prescribing…

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