ACM has closed its investigation into anti-rheumatic drug Humira, and into possible abuse of a dominant position by AbbVie.

In late-2018, the patent on the active ingredient adalimumab, which AbbVie uses in Humira, expired in the Netherlands. This drug is widely prescribed for rheumatism, psoriasis, and Crohn’s disease, among other conditions. Until the patent expired, this drug had the highest turnover of all drugs in the Netherlands. After that, drug manufacturers have been allowed to produce generic variants of the active ingredient, and to market so-called biosimilars.

Afterwards, AbbVie started to offer discounts to the hospitals, only if hospitals enable patients to continue using Humira and not switch to a biosimilar, in order the protect its position at the market. In 2019, ACM launched an investigation into the discounts that AbbVie in 2018 offered hospitals. According to the investigation made, ACM has concluded that AbbVie, as former patent owner, sought to make it harder for biosimilar manufacturers to enter the market.

Abbvie does not accept ACM’s finding however has indicated that fair competition is important for them too. That’s why AbbVie has given the below clarifications:

  • AbbVie ensures that in commercial contracts, it does not include any obligations to purchase exclusively from AbbVie or any clauses that may have a similar effect.
  • AbbVie will remove the reciprocal termination clause from its adalimumab agreement with hospitals, so that AbbVie is unable to terminate agreements without a breach of contract by the hospital.
  • AbbVie will tighten its compliance policy and compliance training, specifically focusing on proper and ethical conduct in procurement procedures, which includes not asking hospitals and other buyers about offers made by competitors and/or their prices. Compliance training will be given at least once a year.

ACM will check whether AbbVie actually does all of the above. ACM expects that this will enable hospitals, patients, and insured to benefit from the improved market-entry opportunities for biosimilars.

(ACM, 24.09.2020)


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