Latest EMA biosimilar guidance on reference products is a “major breakthrough” but there is still work to do, say industry experts.
Last week, the European Medicines Agency (EMA) – unveiled draft guidance that would allow the reference medicines used to support marketing applications for biosimialrs to be sourced outside of the EU. Previously only biologics approved in the Union could be used to assess similarity.
Speaking to in-PharmaTechnologist.com, Suzette Kox of the Euroean Generics Medicines Association (EGA) said the proposed move would be a “great achievement” and would "ensure that there is a level playing field between the biosimilar medicines’ and the originator medicines’ industry.”
Kox, who is senior director of scientific affairs at the EGA, went on to set the proposals in a wider industry context, explaining that: “It was the intention of EU policy makers to avoid unnecessary and potentially unethical repetition of studies which costs for the EU alone between EUR 100 to 250 million depending on the molecule."
However, although pleased with the EMA’s plans on reference products, the EGA believes there is still more work to be done. Kox said: “The issue of the reference product is not the only issue to achieve biosimilars global development but for companies being able to use data from tests with reference products that are not sourced from the EU constitutes a major and far-reaching regulatory breakthrough.”
Services sector thumbs up
Members of the contract services sector - which plays a crucial role in the biosimilar development process - have also welcomed the proposed rules on sourcing as a positive and necessary step.
Pete Gaskin, principal consultant for Aptuit Consulting, told in-Pharmatechnologist.com that the issue has caused significant concern in the industry, specifically over the need to conduct separate studies to satisfy US Food and Drug Administration and EMA requirements.
“The change of approach reflects increasing collaboration between regulators in the US and Europe and brings the European regulators much more closely in line with the US FDA who addressed the issue in their draft Scientific Considerations guidelines for biosimilar products ,” he said.
Niall Dinwoodie, global coordinator of analytical testing, biopharmaceutical services at Charles River Laboratories was of a similar view, telling us the proposed changes are “a logical step” when considering the global nature of biosimilar product development.
He added: “They also reflect the unstated aim of the biosimilar approval process; reducing healthcare cost, by reducing the cost and complexity of bringing biosimilar products to patients,” and that the changes are needed for biosimilars to become “more attractive” to manufacturers.
But despite his response Dinwoodie does not expect the EMA plans - if implemented - to have an immediate impact on the amount of business Charles River Labs' does with the biosimilar sector in Europe.
“To a contract testing organisation it will not have a significant impact as the additional reference products incorporated in comparability programmes have little impact on the overall complexity or value of the characterisation studies,” he said.
“Preclinical studies will have less dose groups if a global reference product can be used but this has little impact on the overall study.”