Freedom of Information request (FOI 22/999)
Published 17 January 2024
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17th October 2022
FOI 22/999
Dear
Thank you for your request under FOIA, where you asked:
“Please provide the date at which the RoActemra (Tociluzumab) label was extended to coronavirus disease 2019 (COVID-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. Please also clarify if this label extension qualifies the originator to receive an additional 1 year of market exclusivity in line with Human Medicines Regulation 2012 (2012/1916), or any other additional market exclusivity granted by the MHRA?”
Our response:
The product is authorised for the indication specified in your enquiry this extension was approved 7 January 2022 for GB. In terms of the Marketing Authorisation (MA), this is a grandfathered MA, so the initial approval was under EMA, with a birth date of 15 January 2009. Data and market exclusivity period entitlements for medicinal products approved before 1 January 2021 continue to be applicable in the UK.
Please note, the product includes paediatric indications which were included under the EMA before the UK’s exit see here for EMA PAR of the variation, so the added 6 months market protection also applies in GB, albeit this period has now expired.
RoActemra did fall under the “significant clinical benefit” at the time the variation was added, and so qualified for the +1 year of protection in principle. However, as it wasn’t during the first 8 years of the MA (2009 + 8 years = 2017) no additional period is conferred. Additionally, the total market exclusivity is 10 years plus 6 months due to the paediatric addition, which has also expired.
We trust that you will find this information of use, this concludes our handling of your request.
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Best regards,
Healthcare Quality and Access (HQA) FOI Team