Five more biosimilar-free years for AbbVie’s Humira

Humira is the key drug for AbbVie, and one the company hopes it will be able to push into the $20 billion region per year region before competition arrives. After a financial deal was agreed with Amgen, it looks like the drug should have the immediate biosimilar threat removed from its path running up to the beginning of 2023.

Amgen’s biosimilar of Humira, named Amgevita, had appeared to threaten potential sales of the big-selling drug but the company’s decision to resolve all pending litigation with AbbVie means that Humira’s sales in the US are now well-protected.

Amgen will, however, be able to launch its biosimilar in Europe without fear of litigation, after the two companies agreed on a launch date of 16 October 2018 in this region. The deal comes with a caveat, as AbbVie revealed that Amgen will have to pay royalties as part of agreement between the two. Meanwhile, the US will have to wait until 31 January 2023 before seeing the biosimilar on the market.

The exact financials of the deal were not revealed but this is a major development in the US biosimilar field. Pfizer has already revealed the difficulty there is in penetrating the market with a biosimilar, after it lashed out with a lawsuit in frustration at its inability to draw sales away from Johnson & Johnson’s Remicade, citing anticompetitive practices on the part of the latter.

The move on the part of two companies will have been received with real interest by companies working on biosimilars, in terms of how their products can be made viable in the US market. Uptake in Europe has been quicker, if not rapid, in Europe so far, but the US still appears to be a tough nut to crack.

"We look forward to leveraging our existing biologics capabilities to bring high-quality biosimilars to patients worldwide. Amgevita will be one of our first biosimilar launches, and this agreement will allow us to secure a strong foothold in the $4 billion European adalimumab market," said Scott Foraker, Vice President and General Manager of Biosimilars at Amgen.

The talk of the European market is an interesting one for the company, as there has been one other approval in Europe recently, for Samsung Bioepis. Whether this company enjoys AbbVie’s nod of approval for a European launch remains to be seen, with analysts widely expecting Samsung’s biosimilar to attempt a launch around October as well.

However, the main winner of this agreement seems to be AbbVie, with Laura Schumacher, Executive Vice President, External Affairs, at the company, talking up the deal as one which "respects the breadth and strength of our intellectual property portfolio". Shares in AbbVie acted accordingly, as they rose 6.1% in response to the news while Amgen’s were 1.65% up in the morning.