Hamira’s key patent get struck down again within few months

Within couple of months since CoherusBioScienceswon, there is yet another pharma company attempting to introduce a biosimilar competitor for the AbbVie’s Humira. This new biosimilar drug would be a new challenge to the megahit rheumatoid arthritis drug.

On this Thursday, in a case that challenged five claims for the ‘135 methods patent on Humira, the United States Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB), following an inter parts review (IPR), has given the verdict in support of BoehringerIngelheim. The ‘135 method patent is counted significant as it includes the treatment and dosing frequency of the medicine; which any company developing biosimilar will require concerning to get agreen lightfor a biosimilar drug from the Food and Drug Administration.

The verdict follows an inter parts review victory for Coherus, who were seeking for the same patent in May. But BoehringerIngelheim's win could create trouble for AbbVie’s Humira, as now; AbbVie will have to plea for both decisions that they have planned to do, according to their emailed statement. It will be quite difficult for AbbVie to overturn the Patent Trial and Appeal Board (PTAB)'s decision.

There is more trouble for AbbVie’s Humira in near future as, the ‘619 patent that includes Humira’s formulation, is also under dispute through inter parts review (IPR). Later this summer, further pronouncements striking AbbVie’s Humira patents are anticipated.

Patent threats are normal for pharma sector, but this is not normal patent challenge. Humira is best-selling drug around the globe and it also contributes around 60 percent of AbbVie’s total revenues. So the drop in sales will hit hard the shares of the company.

Earlier this year, AbbVie has managed a comeback, registering a 15 percent boost in Humira’s sales. That aided to drive overall revenues upbeat 10 percent to USD 6.5 billion as well as net profit up 11 percent to USD 1.7 billion; these are the results that are way better than company’s own projections.

AbbVie’s CEO, Richard Gonzalez reportedly said during the first-quarter earnings call that, AbbVie extends its attempts to branch out further than Humira, although with distinctly diverse results. One of its major achievements is its Leukemia drug, named as Imbruvica that is now dictated to 21 percent of patients affected by chronic lymphocytic leukemia (CLL) as a first-line treatment. The drug ascribes to its 5^thFDA approval prior this year, and gross sales in the 1^stquarter rose 45 percent to USD 551 million.

However, the biosimilar risk to Humira is already aconcern in abroad. Merely last month, the Europe’s Medicines Agency suggested the green light for Imraldi, Humira’s biosimilar. Imraldi is produced by Samsung Bioepis and Biogen. It would be the one more Humira biosimilar following to Amgen’s Amjevita, in the European market. The European Medicines Agency’s suggestion came few months behind; the United Kingdom court regulate that it would not impose AbbVie’s European patents on Humira drug for treatment of psoriatic arthritis, psoriasis, and rheumatoid arthritis.

In the meantime, the Illinois Company is already stimulating for Humira’s decay. In May, Marc Goodman, the analyst at  Swiss global financial services company, UBS has mentioned to investors that AbbVie administrators are predicting Humira will peak abroad sales following year before rival biosimilars take a major share of sales. Then it anticipates seeing international sales drop by 15 percent per year by 2020.