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The British Medicines and Healthcare Products Regulatory Agency (MHRA) has proposed a simplified licensing approach for biosimilars, making the UK a world leader in the regulation of biosimilars.
The MHRA formulated a plan to simplify the licensing of biosimilars last year.
The plan usually does not require comparison of effectiveness data and will consider the exchange of approved biosimilars with reference products for all indications.
Mark Samuels, head of the British Generic Drug Manufacturers Association and the affiliated British Biosimilars Association, commented, "This plan is very popular, and all of our manufacturers want to see the start of this plan.
In addition, he believes, “Once the MHRA launches this program, the UK will become a world leader — a world leader with biosimilar modernization regulations.
Christian Schneider, interim chief scientific officer of MHRA, said that the decision to no longer require confirmatory efficacy trials was brought about by the "excellent drug characterization" that is now possible.
Schneider said, "We are studying responses to feedback," and MHRA acknowledged that the implementation of the new approach has been delayed due to COVID-19 activities.
The EU and the U.
Angela McFarlane, senior director of market development for the UK and Ireland of IQVIA, agreed with MHRA’s plan, “We can see that the UK is a global leader in rapidly approving new biosimilar drugs”, but “the biggest problem is that the US and the EU will follow suit.
She said, “I think the European Medicines Agency (EMA) and the US FDA will pay close attention to the impact of the MHRA policy.
Regardless of the proposed new approach, MacFarlane pointed out that the United Kingdom has “leading the European Union (France, Germany, Italy, and Spain) in the adoption of biosimilar drugs.