Developers of biosimilar medicines could find it easier to gain a licence to market their products in the UK from next year under plans put forward by a UK authority to partly diverge from EU regulations after the Brexit transition period expires.
Life sciences experts David Lancaster, Helen Cline and Krishna Kakkaiyadi of Pinsent Masons, the law firm behind Out-Law, said that the draft new guidance issued for consultation by the Medicines and Healthcare products Regulatory Agency (MHRA), could hasten the process of marketing biosimilar medicines in the UK. The consultation closes on 15 November.
It will remain necessary for biosimilar companies to conduct comparative clinical studies for EU and other global regulatory applications
Biosimilars are products that are highly similar to medicines containing biologic products such as proteins or antibodies. The MHRA's draft guidance aims to provide developers of biosimilars with clear requirements to market and sell biosimilar products in the UK at the end of the Brexit transition period when EU regulatory provisions will no longer directly apply. The UK government has already said that it will use the opportunity to depart from EU rules and regulations, where necessary, to implement a regulatory system that is robust and responsive.
Every medicinal product requires a marketing authorisation (MA) before it can be marketed in the UK and the EU. Some MAs can be granted by individual member states, whereas others must be obtained centrally across the EU from the European Medicines Agency (EMA). The EMA is responsible for evaluating the majority of applications to market biosimilar medicines in the EU.
When the Brexit transition period ends on 31 December 2020, the MHRA will replace the EMA as the body responsible for evaluating MA applications for biosimilar products in the UK. The MHRA plans to finalise its guidance prior to this date so that it can be implemented from 1 January 2021.
Broadly speaking, developers of biosimilars must show the regulatory authorities through comprehensive scientific comparative studies that their product is highly similar to the original approved biologic product, known as the 'reference' medicine. They must also show the authorities that there are no clinically meaningful differences between their biosimilar and the reference medicine in terms of safety, quality and efficacy. The draft guidance published by the MHRA is based on guidelines that have already been prepared by the Committee for Medicinal Products for Human Use (CHMP), a body of regulators within the EMA, for the assessment and the authorisation of biosimilars in the EU.
Importantly, however, the MHRA's draft guidance expressly states that it has departed from the CHMP guidelines in some respects, in light of "the scientific and regulatory experience" since the licensing of the first biosimilar product in the EU in 2006. It refers to a September 2020 review of biosimilar applications in the EU which concluded that "extensive comparative analytical studies" between the biosimilar and the reference medicine, combined with an "abbreviated clinical package", should be sufficient to assess biosimilarity in most cases, with the latter focussed on assessing metabolism, clearance, safety and immunogenicity of the biosimilar product in the body.
The UK MHRA's support for the use of in-depth knowledge of the reference product and laboratory analytical techniques to predict clinical comparability of biosimilars could reduce the need for developers to conduct head-to-head efficacy trials between biosimilars and reference medicines.
The answer lies in having a regulatory framework that is able to keep pace with and take advantage of the trends in the industry such as personalised medicines, the search for value and efficiency, big data and artificial intelligence
David Lancaster said: "Although it will remain necessary for biosimilar companies to conduct comparative clinical studies for EU and other global regulatory applications, comparative efficacy and safety studies may no longer be required in the UK in most cases. It remains to be seen whether this proposed relaxation of the regulatory framework in the UK will influence the approach taken in other countries."
Krishna Kakkaiyadi said: "The UK government's overall industrial strategy to fold in sophisticated in vitro analytical tools, data sciences and AI in the regulation of the life sciences sector is definitely the right step to take in keeping pace with innovation. In relation to biosimilars regulation, it will be interesting to review responses from all relevant stakeholders in the sector, including biologics and biosimilars developers – their level of appetite for change will probably determine how significantly the UK departs from the EU regulatory framework in the near term."
Helen Cline said: "Although there are challenges and risks for industry as the UK leaves the EU, Brexit may facilitate a new global role for the UK in life sciences. The answer lies in having a regulatory framework that is able to keep pace with and take advantage of the trends in the industry such as personalised medicines, the search for value and efficiency, big data and artificial intelligence (AI). The MHRA's proposal for a change of approach to the licensing of biosimilars is perhaps the start of that journey."
In an update to the UK's life sciences industrial strategy published in January this year, the UK government committed "to create maximum flexibility for innovative and responsive approaches to regulation, using health data to underpin rapid progress in the field" after the Brexit transition period expires.
Health secretary for England, Matt Hancock, has also previously stated in parliament that the proposed new Medicines and Medical Devices Bill "gives us the means to depart from EU rules and regulations in future, moving at a faster pace, if that is what we choose to do as an independent, self-governing nation". He said the Bill also "ensures that we can easily amend regulation through secondary legislation without having to bring a new Bill before the House every time we need to revise the rules", enabling the UK's regulatory system to "be flexible and responsive, quick to adapt to innovation and quick to respond when a safety issue emerges".
Co-written by Krishna Kakkaiyadi of Pinsent Masons. David, Helen and Krishna can be contacted for discussions on the MHRA's consultation and the submission of responses at [email protected].
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