MHRA Nixes Confirmatory Clinical Trial Requirement for Biosimilars

BRUSSELS, Belgium – Members of the European Parliament (MEPs) have come out in support of waiving intellectual property rights (IPR) for COVID-19 vaccines.

In a resolution, the members adopted the idea with 355 votes in favor, 263 against and 71 abstentions with regard to a temporary waiver of the WTO TRIPS Agreement on patents to improve global access to affordable COVID-19-related medical products.

The group voted on the temporary waiver, citing concerns that an indefinite TRIPS Agreement waiver would pose a risk to research finance, in particular for researchers, investors, developers and clinical trials.

MEPs also called on the EU “to rapidly eliminate export barriers and to replace its own export authorization mechanism with export transparency requirements” in order to address production bottlenecks.

Initial Uncertainty

LONDON, United Kingdom – The United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has removed the requirement for biosimilar drugs to undergo confirmatory clinical trials in humans before being approved for use, reported the Telegraph.

After years of monitoring and data collection, MHRA believes that 50 to 60 laboratory tests are now enough to ensure the safety and efficacy of biosimilars, thereby supporting the regulator’s decision to nix the requirement for confirmatory testing.

MHRA’s European and United States counterparts have yet to augment their guidance on biosimilars, which means the UK anticipates being a first-launch market for these products, and the NHS will receive biosimilars a year earlier.

As quoted by The Telegraph, Mark Samuels, Chief Executive of the British Biosimilars Association, said, “The new guidance puts the UK ahead of the rest of Europe when it comes to regulatory innovation and could provide a further catalyst to a biosimilar boom in the next decade.”

Over the next 15 years, the European patents for more than 30 biosimilars are set to expire, including for Novartis’ Lucentis (ranibizumab), which is good news for the UK, considering 80% of the most expensive drugs used by the NHS are biologics.

Biosimilars to AbbVie’s Humira (adalimumab) are expected to save expected to save the NHS £300 million by the year’s end, and with more patents set to expire in the coming years, and biosimilars expected to arrive to market earlier, the NHS could save “hundreds of millions of pounds,” said Samuels.