Boehringer Ingelheim to Pull Out of EU Biosimilars Market, Focus on US

Earlier this week, Bioprocess International reported that Boehringer Ingelheim (BI) had decided to focus on launching its biosimilar products solely in the US market, and would forego launches in the European Union (EU). The Center for Biosimilars^® was able to independently confirm this report in an email with a representative from BI.

“Our focus is on bringing Cyltezo (adalimumab-abdm) to the US market and we are committed to making it available to US patients as soon as possible, and certainly before 2023,” said the BI spokesperson.

“Boehringer Ingelheim believes the introduction of high-quality, lower-cost biosimilars is critical for both patients and the sustainability of the healthcare system. At this point in time, future biosimilars activities will be driven out of the US market, including partnership opportunities, while Boehringer Ingelheim is stopping development activities for the rest of the world,” said BI’s representative.

AbbVie, the developer of reference adalimumab sold as Humira, has entered into 6 patent litigation settlements with biosimilar adalimumab developers to date. Under the terms of each settlement, approved biosimilar adalimumab products were able to launch in the EU as recently as last month, while the US market will have to wait until 2023 to see any of those products enter the market.

BI alone has not settled its patent dispute with AbbVie, and the case over Cyltezo is moving forward in a Delaware District Court. In the suit, AbbVie asserted 74 patents covering its reference adalimumab product. BI is arguing that that AbbVie engaged in a “pattern of pursuing numerous overlapping and non-inventive patents for the purpose of developing a ‘patent thicket,’ using the patenting process itself as a means to seek to delay competition.”

To support its defense, BI asked the court to compel AbbVie to produce research and development documents dated outside the default 6-year period. Though the court rejected BI’s argument that the case was “unusual given the number of patents and claims at issue,” the court did order AbbVie to produce such documents in June 2018, finding that the information is relevant to the litigation.

BI is also investigating interchangeability of its product with the reference Humira.