New No-Deal Brexit Guidance Holds Changes for Biosimilars

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.”