Germany-based drugmaker Boehringer Ingelheim (Boehringer) received approval for its Humira biosimilar from the US Food and Drug Administration (FDA) in 2017 and is currently working towards launching in the US. However, it must contend with a lawsuit from AbbVie alleging infringement on dozens of Humira patents. Boehringer has so far resisted making a deal with AbbVie unlike other competitors; eight biosimilar companies have so far made settlements with AbbVie agreeing their US launches throughout 2023 [1]. Boehringer argues that AbbVie’s entire lawsuit should be struck aside as it is unfairly using a ‘patent thicket’ of overlapping and add-on patents as well as the litigation process itself, to protect its blockbuster. Meanwhile, in Europe, Humira’s composition of matter patent expired in October 2018, opening the door to eight biosimilars already approved by the European Commission.

In the latest development in the Boehringer challenge, when AbbVie had previously been ordered to hand over documents to Boehringer, Boehringer found some were missing and asked the court to force AbbVie to produce its documents. AbbVie pushed back, claiming Boehringer’s new request included additional documents. On 11 February 2019, Judge Richard Lloret ordered AbbVie to hand over the documents in a Delaware federal court, stating that ‘the requested documents are within the scope of Boehringer’s defence’ and claimed that AbbVie set up a ‘straw man’ to mislead the court about Boehringer’s argument.

Back in February 2017, Quebec’s then Minister of Health and Social Services, Dr Gaétan Barrette, published a notice removing Remicade from the List of Medications soon after entering a product listing agreement with the manufacturer of Inflectra, a Remicade biosimilar. In January 2019, the Quebec Court of Appeal ordered that Remicade be reinstated on the List of Medications, declaring that the minister had failed to respect the minimum requirements of procedural fairness that applied in the circumstances. Remicade’s manufacturer Janssen was given no prior notice of the decision, no opportunity to present its comments on the forthcoming decision and no reasons for the decision. The Court of Appeal applied a duty of fairness on the basis that listing or delisting a drug on the List of Medications is an administrative decision, not a regulatory decision, and is therefore subject to judicial review based on the standard applicable to administrative decisions. This decision by the Court of Appeal is likely to broaden the potential basis for judicial review of ministerial decisions on listing and delisting drugs on the List of Medications, and will oblige the Minister of Health and Social Services to take into account procedural fairness requirements in future.

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. AbbVie makes more deals delaying adalimumab biosimilars in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Mar 8]. Available from: www.gabionline.net/Pharma-News/AbbVie-makes-more-deals-delaying-adalimumab-biosimilars-in-the-US 

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