Thanks to the European Commission, Biogen can extend Tecfidera monopoly for at least two more years.

And nobody seems to know why.

According to an investigation by Follow the Money, a Dutch investigative journalism outlet, the European Commission restored the market exclusivity of Tecfidera, a multiple sclerosis medicine marketed by Biogen. By doing so, the European Commission ignored the scientific assessment of the European Medicines Agency (EMA) that there was a lack of convincing scientific evidence that Tecfidera was indeed a new medicine, which is a requirement for obtaining regulatory market exclusivities. 

The Commission also usurped the role of national courts and national regulatory agencies, say multiple sources in the generic industry. Adrian van den Hoven, director general of the generic industry’s interest group, Medicines for Europe, claims this is the first time that the Commission intervened in this space of exclusivity enforcement. ‘This is uncharted territory, so who knows where we will land’, he says.

Tecfidera was originally approved for marketing in 2014. After eight years, the monopoly on the lucrative multiple sclerosis drug was set to end in February 2022. Legal challenges brought by a generic company against the EMA led to a ruling by the European General Court in May 2021 that invalidated Biogen’s monopoly. This prompted a reassessment by the EMA of the drug’s differences from its predecessor, the old psoriasis drug Fumaderm. The available evidence, including studies provided by Biogen, was found to be flawed and inconclusive by the EMA’s Committee for Medicinal Products for Human Use (CHMP), leading to the conclusion that there was no therapeutic difference between Tecfidera and the original drug, Fumaderm. Accordingly, CHMP concluded that Tecfidera was unjustly assigned ‘new active substance status’ in 2014, resulting in ten years of exclusivity that it should not have had. This means that Tecfidera should have fallen under the global marketing authorisation of Fumaderm.

However, the European Court of Justice later annulled the ruling of the General Court, referring to the strict definition of when a product falls under the ‘same’ global marketing authorisation. Additional strengths, new pharmaceutical forms, new administration routes, presentations, variations and extensions are all considered continuations of existing therapies. Substances containing different ‘therapeutic moieties’ or active substances, however, are not. 

Importantly, in reaching its conclusion, the Court of Justice was not allowed to consider the CHMP assessment from 2021, since it was not part of the appeal procedure. If it had done so, the Court might have come to the conclusion that Tecfidera fell under the regulatory dossier of Fumaderm, for which the regulatory exclusivity period had long expired. The EMA explicitly approved generic forms of Tecfidera after the publication of this assessment in 2021. Nevertheless, the Court of Justice’s ruling opened the way to restoring Tecfidera’s market exclusivity.

In the assessment, the CHMP was quite sceptical about the claim Fumaderm and Tecfidera were therapeutically different treatments. The totality of the data suffered from ‘severe methodological limitations’, were ‘exceedingly vague and unsubstantiated’ and ‘are rather consistent in that no difference between the two treatments could be established’ the CHMP concluded.

Thus, Tecfidera was a repackaged version of an existing drug, not a new therapy as claimed in 2014. 

The CHMP assessment did trigger a dramatic price reduction, as generic suppliers vied for a share of the market, resulting in substantial discounts. In the Netherlands, this competition led to annual savings of € 45 million once generics entered the market. But in early May of this year, the European Commission concluded this assessment was ‘no longer relevant’, refusing to answer multiple requests by Follow the Money to explain why it was not. Biogen, Biogens’ attorney Carla Schoonderbeek and the European Medicines Agency also failed to offer an explanation to Follow the Money.

Follow the Money cites multiple legal letters from Schoonderbeek seeking to prohibit health insurance companies from reimbursing generic forms of Tecfidera. In one, she writes the European Commission decided to amend the marketing authorisations for generic Tecfidera to ‘provide legal certainty’ as requested by Biogen. Since the marketing authorisation in 2013, Biogen raked in more than $ 30 billion on sales of Tecfidera.

Van den Hoven fears big pharmaceutical companies have now found a new way to disrupt fair competition, he says. ‘The implications could be far bigger than this individual case for the EU because of the changes to the pharmaceutical legislation where data exclusivity periods will be modulated’.

You can read the article (in Dutch) by Follow the Money here:

Medicines Law & Policy
Medicines Law & Policy
Medicines Law & Policy brings together legal and policy experts in the field of access to medicines, international law, and public health. We provide policy and legal analysis, best practice models and other information that can be used by governments, non-governmental organisations, product development initiatives, funding agencies, UN agencies and others working to ensure the availability of effective, safe and affordable medicines for all.


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