UK Proposes Shorter Time Frame for Biosimilar Authorization Amid Brexit Shortage Fears

The United Kingdom has opened a consultation on provisions that it hopes will ensure the supply of medicines in the event that no agreement can be made between the United Kingdom and the European Union before the Brexit deadline.
The Center for Biosimilars Staff
October 05, 2018
The United Kingdom has opened a consultation on provisions that it hopes will ensure the supply of medicines in the event that no agreement can be made between the United Kingdom and the European Union before the swiftly approaching Brexit deadline.

Among the proposals set forth in the consultation is a licensure timeframe of just 67 days from the submission of an application for a biosimilar or other product that qualifies for a “targeted assessment” that has received a positive opinion from the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP).

The consultation notes that the current licensing route takes 210 days. In order to take advantage of the new, faster route, the drug company seeking a marketing authorization would submit to the Medicines and Healthcare Products Regulatory Agency the same dossier as submitted to the EMA. The consultation will remain open to comments until November 1. 

With mere months before the United Kingdom exits the European Union, and as fears grow that no trade deal will be reached, many drug makers have taken it upon themselves to stockpile products to ensure supply. Drug makers including Sanofi and Novartis confirmed in August that they are holding extra units of their products so that patients will not have to go without their medication in the event of such a disruption to trade, and AstraZeneca followed suit in late September. 

Meanwhile, the United Kingdom’s health secretary has revealed that the government is in talks with drug makers about covering the cost for stockpiling drugs—or even flying in crucial medicines from abroad—in the event of delays at customs borders.

One bright spot in the Brexit landscape, however, is a recent EMA announcement that the agency has revised the number of medicines that it says could face supply disruptions in the wake of Brexit as a result of companies’ failures to submit transfers, notifications, or variations to their marketing authorizations. 

While the agency had previously raised concerns about 108 of the 694 products centrally licensed in the United Kingdom, it contacted the marketing authorization holders about the potential for supply disruption and now says only 25 medicines for human use face possible shortages. The EMA is working with the license holders for these products to address outstanding issues, and it notes that it is also working with its scientific committees on mitigation measures that include making recommendations on possible therapeutic alternatives to which patients may be switched if necessary.

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