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A raft of guidance relevant to the off-patent industry has been published by the UK’s Medicines and Healthcare Products Regulatory Agency covering arrangements that will come into force at the end of the UK’s Brexit transition period, on 1 January 2021.
While the guidance – which includes documents on licensing biosimilars, comparator products in bioequivalence studies for generics and how active substance master files and certificates of suitability (CEPs) will be handled by the MHRA – has been welcomed by local industry body the British Generic Manufacturers Association, the organization has also warned that time is short to prepare for the end of the transition period with the EU, while new guidance in certain areas remains “critical.”
For biosimilars, the MHRA says that “from 1 January 2021, the MHRA will regulate biosimilar products according to the same principles that are applicable now. Northern Ireland will follow the EU acquis and the MHRA will regulate applications for biosimilars from 1 January 2021 accordingly.”
“New applications to Great Britain will be assessed at national level and should be submitted using existing procedures for national applications,” the guidance says. “Data and market exclusivity period entitlements for reference medicinal products approved before the date of UK exit from the EU will continue to be applicable in the UK.”
Earlier this year, the MHRA had promised a “new innovative UK licensing procedure for biosimilar products” from 1 January 2021 that would “reduce the burden on clinical trial data generation” for applicants. (Also see "UK Promises Reduced Trial Burden For Biosimilars" - Generics Bulletin, 10 Jun, 2020.)
On comparator products for bioequivalence studies for generics, the guidance provides information on bridging requirements for non-Great Britain comparator products that “should be authorized in and sourced from a country with similar scientific and regulatory standards as the UK.” This guidance does not apply to biosimilars.
And on ASMFs and CEPs, the guidance confirms that the MHRA “will continue to accept an ASMF and/or a CEP in both new national initial marketing authorization applications and in marketing authorization variation applications.”
“CEPs are not affected by the UK leaving the EU as they are issued by the European Directorate for the Quality of Medicines and Healthcare,” the guidance explains. “This is a directorate of the Council of Europe and a body that is independent of the EU. On leaving the EU, the UK will remain a member of the Council of Europe and a signatory to the Convention on the Elaboration of a European Pharmacopoeia.”
Responding to the latest MHRA guidance, BGMA technical director Paul Fleming said the association was “pleased that the MHRA has at last started to publish regulatory guidance on how to navigate the end of the Brexit transition period.”
However, he warned, “with less than four months to go we are very short of time. As such, it is good to see that much of the guidance is the same as that produced a year ago to manage a no-deal Brexit, which means industry is already familiar with a lot of the content.”
“As an industry, we will be working closely with MHRA over the next few weeks to help ensure that generic and biosimilar manufacturers fully understand the operational details,” Fleming confirmed. “One area we will be paying close attention to is any changes impacting the research and development of new generic medicines and their on-time availability to the National Health Service and patients.”
“Within that, the new guidance on clinical trials and equivalence studies for generic and biosimilar medicines is critical,” Fleming pointed out, “since product development programs are planned many years in advance.”
“Any major regulatory changes run the risk of duplication and delays in the availability of medicines for UK patients, particularly if implemented in haste.”
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