This week, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) issued updated guidance for industry on preparing for the growing likelihood that the United Kingdom will leave the European Union without a trade deal.
This week, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) issued updated guidance for industry on preparing for the growing likelihood that the United Kingdom will leave the European Union without a trade deal.
According to the new guidance, in order to ensure that drugs that reach the United Kingdom via the European Union’s centralized marketing authorization route can continue to be provided to UK patients, all EU centrally authorized products will automatically be granted UK marketing authorizations on the date of the UK exit.
The MHRA will also offer new assessment procedures for new active substances and biosimilars that have received positive opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). The MHRA will review applications for all such products within 67 days, it said, and will thereafter provide a “rolling review” of biosimilars that will allow companies to apply for authorization of a biosimilar product in stages throughout the product’s development.
Looking ahead, says MHRA, biosimilar developers will not be allowed to rely on data from EU-licensed reference products that are not licensed in the United Kingdom. Fees for assessments of biosimilars with the goal of obtaining a UK marketing authorization will be £17,330 (approximately $21,961).
The guidance also sets forth an intention to create a UK system for addressing orphan drugs to treat rare diseases. This system, says MHRA, will mirror EU criteria, but will be based on the prevalence of the rare diseases (and the availability of alternative treatments) in the United Kingdom rather than in Europe at large. The system will refund 100% of the initial marketing authorization application fee for small and mid-sized UK companies—and 10% for other applicants—of approved orphan drugs, and will provide fee waivers for the first year after approval. The United Kingdom will retain 10-year market exclusivity for approved orphan drugs under this system.
In a statement, Ian Hudson, MD, the outgoing CEO of the MHRA, said that “The responses to our consultation have helped us prepare a robust plan to make sure our regulatory processes for medicines, clinical trials, and medical devices are fit for purpose on exit day.” He added that “We are committed to giving businesses and individuals as much certainty as possible, as soon as possible, to make sure the [United Kingdom] continues to be at the forefront of regulatory innovation and processes.”
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
BioRationality: MHRA's Procedure Enables Automatic Registration of Biosimilars Approved Elsewhere
March 18th 2024Sarfaraz K. Niazi, PhD, explains how the new international recognition procedure under the Medicines and Healthcare Products Regulatory Agency (MHRA) could expand biosimilar access within the United Kingdom, in his latest column.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
Coherus Biosciences Cites Biosimilars as Main Drivers of 2023 Revenue Growth
March 14th 2024In its earnings report for the fourth quarter and full year of 2023, Coherus Biosciences detailed its rising revenue growth, which it partly attributed to increased sales for its pegfilgrastim and ranibizumab biosimilars.
Filgrastim Biosimilars in Europe: 15 Years of Real-World Evidence for Zarxio
March 13th 2024A review looking back at the last 15 years of experience with the first filgrastim biosimilar (Zarxio) provides a detailed overview on how filgrastim biosimilars came to be and the evidence behind why oncologists have come to accept them as standard practice.