Europe Weighs the Merits of Duplicate Marketing Authorizations for Biologics

This article has been updated.

This month, the European Commission’s Pharmaceutical Committee, part of the Health and Food Safety Directorate-General, updated EU member states as to the results of a targeted consultation it undertook in 2018 on a specific type of duplicate marketing authorization applications (MAAs) for originator biologics and their potential impact on biosimilars.

Under the current centralized procedure, 1 MAA can be granted to an applicant for a particular drug, but on a case-by-case basis, the commission can assess whether there are valid reasons related to public health, drug availability, comarketing, or intellectual property that would warrant allowing for second or multiple authorizations.

With respect to biologics, granting duplicate MAAs has raised concerns about competition; some stakeholders have argued that there could be an impact on the biosimilar market if an originator product’s developer were to seek an Article 10.1, or so-called “generic legal basis,” duplicate MAA to sell another version of the same biologic, similar to the way a company might sell an authorized generic in the US context. Because national pricing, reimbursement, and pharmacy substitution rules are linked to regulatory status, duplicate MAAs could impact choice and competition, some fear.

In the consultation, 9 member states and 10 representatives from industry, patient groups, and provider groups submitted feedback, says the commission. Arguments in favor of stricter scrutiny for originator’s Article 10.1 duplicate products, which the commission terms “autobiologicals” to differentiate them from biosimilars, revolved around concerns about autobiologicals’ potential impact on the market.

The presence of such autobiologicals could impact market access for biosimilars, and they could have privileged positions in terms of pharmacy-level substitution in some EU states, said those in favor of stricter regulation. Stakeholders also raised concerns that clinical decision-makers could be swayed by misconceptions about therapeutic differences between autobiologicals and biosimilars, that pricing could be impacted, and that tendering processes could be improperly affected.

Among those who did not see a benefit to stricter scrutiny, on the other hand, arguments indicated that autobiologicals could improve availability of biologic therapy.

Member states’ national competent authorities provided feedback that indicated that there is no experience to date on the actual impact of duplicate MAAs for biologics in terms of availability, however. All member states that participated in the consultation—with the exception of Hungary—agreed that the commission should revise its guidance to indicate that duplicate MAAs should be properly substantiated and based on sound evidence, but numerous states sought further explanation of what such substantiation and evidence would involve.

Currently, there is 1 Article 10.1 duplicate MAA for Lifmior, or etanercept. Lifmior, a duplicate of Enbrel, has not been launched, however.