by Janelle Dumalaon at the DIA Biosimilars Conference
BERLIN, Dec 3 (APM) - Europe's most senior biosimilars regulators have dismissed the idea that levels of similarity to the originator product have to be defined for all biosimilars - as is done in the U.S. - cautioning that such an approach may impact pricing, a conference heard.
Christian Schneider, chairman of the CHMP’s Biosimilar Medicinal Products Working Party (BMWP), said on Tuesday at the Drug Information Association's Biosimilar Conference in Berlin, that the European regulator did not need such distinctions.
“To us if it is authorised (for marketing), then it is because it was close enough to the original to be authorised. While how much difference we allow from the originator is also a factor, the differences we allow would not be major,” he said during a panel discussion.
The U.S. Food and Drug Administration (FDA) has a classification system in place characterising a biosimilar in relation to a reference product, the categories being “not similar”, “similar”, “highly similar”, “highly similar with fingerprint-like quality”.
But voices from the conference supported Schneider’s, saying there was no need to do the same in Europe, with some saying the FDA’s actions were directed by U.S. legislators.
“The FDA is struggling with biosimilars and interchangeability because Congress has decided that this is the way to go about it,” said Steffen Thirstrup, director of regulatory and health technology assessment consultancy NDA Group.
He added: “My personal opinion is that you will end up creating “business” and “economy class biosimilars”, indicating that the differing classifications may impact pricing.
Martijn van der Plas of the Medicines Evaluation Board in the Netherlands backed up Schneider and
Thirstrup, saying the EMA biosimilar guidelines are written with marketing authorisation in mind, based on scientific questions, and is completely divorced from pricing.
Thirstrup, saying the EMA biosimilar guidelines are written with marketing authorisation in mind, based on scientific questions, and is completely divorced from pricing.
“The European way of applying an identical approach to all biosimilars, under a single umbrella is a fruitful approach from a regulatory standpoint,” van der Plas said.
Schneider also responded to participant comments about how the EMA’s recently revised biosimilar guidelines (APMMA 40276) that are meant to avoid unnecessary clinical trials for biosimilars are a “hard-sell” for the clinical community - saying the resistance to the idea is not “scientific”.
“The concept is that the data should be enough to show biosimilarity, such that additional data would not bring so much more value,” Schneider said.
He added: “We should not have to create ‘nice to know’ clinical data for the clinical community.”
Schneider similarly dismissed concerns the clinical community would take issue with the extrapolation of indications - that a biosimilar would have all the same indications as the approved reference product.
“It is not up to the clinical community to ‘accept’ extrapolation or not, we are the regulators assigned to assess this,” Schneider said.
Ahead of the conference, Thirstrup told APM he believes the biggest hurdle remains dissuading physicians and patients from a reluctance to use biosimlars, as well as a bridging their knowledge gap. (APMMA 40640)
jd/hlc
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