EC Considers Amending Provision on Duplicate MAAs for Biologics

Regulatory NewsRegulatory News | 18 November 2019 |  By 

Earlier this month, the European Commission’s (EC) Pharmaceutical Committee met to discuss how the use of duplicate marketing authorization applications (MAAs) — including the use of duplicate reference biologics, dubbed “autobiologicals” — can impact the availability and pricing of biological products and biosimilars.

Requests for duplicate MAAs under Article 82(1) of Regulation (EC) No 726/2004 have increased steadily, and this is a trend that is likely to continue, the EC said in its note on duplicates in 2011. Biosimilars developers also have obtained duplicate MAAs to increase the availability of such products in certain markets.

But member state national competent authorities (NCAs) and those representing the generic and biosimilar industries, including Medicines for Europe, are calling for stricter scrutiny of autobiologicals (which are similar to authorized generics in the US), especially as they can be considered generics and therefore cut biosimilars out of certain markets where pharmacy substitution for biosimilars is not allowed.

The use of such autobiologicals can also allow originator companies “to severely undercut the price of potential biosimilar competitors while allowing the reference originator product to maintain a high price,” the competent authorities explain. And in countries that have multi-winner tender systems, such as Italy, the original biologic and the autobiological, both from the same originator company, could theoretically win the tender process together.

“In such a case, the originator company would essentially be competing against itself with two of its own MPs [biological medicinal products], possibly even produced in the same manufacturing plant. Such practices can be unfavourable to competitors and may also lead to supply disruptions,” the comments say.

Revision and Pushback

The change the EC proposes would note: “Requests for duplicate marketing authorisations need to be properly substantiated and based on sound evidence.”

Except for Hungary, all member state NCAs participating in the EC consultation, which included those from Belgium, Denmark, Spain, Finland, France, the Netherlands, Portugal and Sweden, agreed that the guidance on duplicate MAAs needs to be revised. Almost all sought further clarity to explain “properly substantiated” and “sound evidence.”

But originator companies, including Pfizer and Sanofi, said the EC needs to clearly explain why there needs to be a change.

“Any change to such practice needs to be properly justified, clearly stating the reasons why the introduction of a first generic of a chemical medicinal product is considered to improve the availability of the product and why, either in general or under specific circumstances, the introduction of a ‘first generic’ of a biological medicinal product is not,” they wrote.

Originator companies also claim that the first introduction of an autobiological “will inherently increase availability of the said medicinal substance on the market” and can be marketed alongside the reference product and competing biosimilars.

They also note that there is no reason to exclude biologics from the application of the duplicate guidance or require any additional evidence over and above what is necessary for small molecule products.

Member state competent authorities maintained that duplicate biologics could “deter competing biosimilars from entering or staying on the market. Therefore, the introduction of an autobiological on the market can have (theoretically at least) negative effects on availability in the long term as biosimilars have a proven record in improving availability.”

In its summary of the comments, the EC noted that member state NCAs recognize that autobiologicals “have a potential to adversely affect availability in the long run. Most arguments however are made on a theoretical basis, as there is still not enough experience to draw practical conclusions on the issue.” The need for additional clarity on any changes was also noted.

Duplicate marketing authorisations for biological medicinal products


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy