by Janelle Dumalaon
BERLIN, Dec 4 (APM) - The European Medicines Agency (EMA) has rejected claims it is "running away" from leading the world in the regulation of biosimilars, saying it does not have the capacity for the role and its standards are too high for many countries to meet.
The comments from CHMP Biosimilar Medicinal Products Working Party (BMWP) chair, Christian Schneider, came after the issue of what the agency was doing to improve global regulatory standards for biological copies was raised at both days of the DIA Biosimilars conference in Berlin.
While critics, which included Roche regulation/biologicals expert Thomas Schreitmueller who made the “running away” comment, in effect accusing the regulator of failing in a duty, Schneider argued the barriers to such a mission were too high.
Schneider conceded that the rest of the world could benefit from Europe’s experience and expertise as it put its standards for biosimilars together but the BMWP was not in a position to take a global lead.
“The biosimilar working party is small but effective. That means we are busy. We cannot provide these kinds of trainings,” he said on Tuesday, responding to a question from pharma as to what Europe was doing to share its knowledge.
He also acknowledged an ethical duty to share the EMA’s know how but this time said he doubted whether many countries could afford to implement the kind of standards Europe is putting in place.
On Wednesday, Europe’s reluctance to leading the global discussion on biosimilar standards was criticised again, this time in relation to promoting the World Health Organization’s proposal of assigning 'biological qualifiers' (BQs).
These are random four-letter codes assigned to biologicals, meant to help deal with differing nomenclature standards around the world, and to track adverse events to specific manufacturers.
“Europe does not want to take global responsibility. Europe is running away. Europe has to play an important role in setting the stage and bringing others on board,” Roche’s head of technical regulatory policy and strategy biologics Schreitmueller said.
He added: “It would really be great if everybody understands, there is a true need in many places of the world for Europe’s help to implement this, to help people understand BQs on a global level.“
Without directly addressing Europe’s role, Schneider said the question that needed answering was, what was the best way to communicate BQ’s relevance?
He said: “The question is the best way to do this. It would be good to have an impact assessment. What would happen if we had BQ, what would happen if we didn’t? “
jd/ns
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