ITC to investigate Alvotech’s Humira biosimilar
The US International Trade Commission (ITC) will investigate whether drug manufacturers used trade secrets to develop a biosimilar of AbbVie’s Humira (adalimumab).
In a notice posted to the ITC, the agency gave the go-ahead for a Section 337 investigation into AlvoTech, Ivers-Lee and Teva Pharmaceuticals’ planned adalimumab biosimilar.
The investigation has been assigned to Administrative Law Judge (ALJ) Monica Bhattacharyya.
While other companies are developing biosimilars of the drug and have received regulatory approval, including Amgen, Boehringer Ingelheim, and Pfizer, AbbVie contests that AlvoTech, Ivers-Lee and Teva’s biosimilar is developed with trade secrets that were stolen from AbbVie.
Specifically, AbbVie claimed that AlvoTech hired several of its “high-profile employees” knowledgeable of Humira’s manufacturing process, highlighting one former employee who AbbVie claimed had taken “confidential documents” with them in the move to AlvoTech.
In its complaint against AlvoTech, AbbVie requested that the ITC bar imports or sales of its biosimilar (known as AVT02) as it would “undercut Humira significantly” and “lead to lower revenue, lower profits, reduced return on investment and, as a result, significant injury to the industry”.
AbbVie has enjoyed an almost two-decade monopoly on the blockbuster drug, which remains the single highest-grossing drug in the US.
Investigation pushback
The Association for Accessible Medicines (AAM) and its biosimilars council filed a public interest statement against AbbVie’s complaint, holding that the investigation will “adversely impact the public health and welfare” of the public.
While AAM claimed to “take no position” on the merits of AbbVie’s trade secrets claims, it remained concerned that the requested relief would be in interest to the public.
“Congress has already expressed public interest concerns regarding the high costs of AbbVie’s adalimumab prescription drugs and ways in which AbbVie has sought to bar others from competing in the adalimumab market,” AAM said.
AAM claims that blocking Alvotech’s biosimilar in particular (which boasts the same concentration as higher concentration Humira) would “stifle the only direct competition” to the drug.
The association recommended rejecting AbbVie’s request for relief and recommended referring the matter to the ALJ for a public interest assessment.
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