AbbVie faces the biggest challenge yet to its best-selling medicine, Humira, as an unlikely Icelandic drugmaker launches a legal fight over outrageous patents

The Icelandic generic-drug expert Alvotech just recently presented a legal fight versus AbbVie, challenging the patents that secure its very popular medicine, Humira. Alvotechs goal is to introduce a copycat variation of Humira that would be cost a less expensive rate, called a biosimilar.Launched in 2003, Humira is the drug industrys all-time very popular medicine. In each of the past 3 years, Humira has brought in about $20 billion in international earnings for AbbVie– by far the industrys top-selling drug.Alvotechs problem, filed Tuesday in US District Court for the Eastern District of Virginia, declares that AbbVie has protected an “outrageous number of patents of dubious credibility” for Humira that have actually reduced competition.

Alvotech creator and chairman Robert Wessman.

This post was updated on May 18 with details on the Congressional hearing.

Other biosimilar manufacturers are dealing with the older variation of Humira, Wessman mentioned, which has really been efficiently phased out of usage by AbbVie. If Alvotech accomplishes success in challenging Humiras patents, that shift may need to happen even sooner.In May 2020, AbbVie closed a $63 billion acquisition of Botox-maker Allergan, decreasing AbbVies reliance on Humira. Humira consisted of 61% of AbbVies profits in 2018 and 43% last year.Gonzalez has in fact similarly talked up the business future of 2 autoimmune-disease treatments called Skyrizi and Rinvoq, which he thinks can replace Humira.

In each of the previous 3 years, Humira has actually brought in about $20 billion in international earnings for AbbVie– by far the industrys top-selling drug.Alvotechs complaint, submitted Tuesday in United States District Court for the Eastern District of Virginia, declares that AbbVie has actually secured an “outrageous number of patents of suspicious credibility” for Humira that have stifled competition.” Our goal is usually to revoke all of the patents we require to invalidate to get to market,” Robert Wessman, the chairman and creator of Alvotech, told Insider in an interview Wednesday.Alvotech is the only company to contest Humiras patents instead of settling with AbbVie for a licensing offer.” AbbVies Humira patents show the revolutionary work of its researchers and medical teams,” an AbbVie representative informed Insider. If Alvotech is effective in challenging Humiras patents, that shift might need to happen even sooner.In May 2020, AbbVie closed a $63 billion acquisition of Botox-maker Allergan, lowering AbbVies reliance on Humira. Humira made up 61% of AbbVies earnings in 2018 and 43% last year.Gonzalez has actually likewise talked up the business future of 2 autoimmune-disease treatments called Skyrizi and Rinvoq, which he thinks can replace Humira.

AbbVie initially sued Alvotech on April 27 for infringing on its Humira patents, an AbbVie representative stated, calling this new match “duplicative to the very first suit AbbVie submitted.”” AbbVies Humira patents show the advanced work of its scientists and medical groups,” an AbbVie spokesperson informed Insider. “Many of the Humira patents have actually been challenged unsuccessfully in IPR [inter partes evaluation] procedures. Particularly, the Patent Office has actually rejected as unwarranted 4 different credibility attacks on amongst the asserted patents.” Alvotech stands alone in combating, instead of settling, with AbbVie.

On the other hand with other nations, Humira still delights in a monopoly in the US.Biosimilar variations introduced in Europe more than 2 years back and now comprise about 58% of the market, according to a March 17 report launched by Bernstein market specialist Ronny Gal. A number of Humira biosimilars have in fact likewise launched in Canada.Generic competitors is among the necessary forces that help keep drug rates and costs under control in the United States. Humira sales outside the US have actually fallen from $6.3 billion to $4.3 billion to $3.7 billion in that very exact same period.

Alvotechs goal is to introduce a copycat variation of Humira that would be cost a less expensive rate, called a biosimilar.Launched in 2003, Humira is the drug markets all-time very popular medicine. In each of the past 3 years, Humira has brought in about $20 billion in worldwide income for AbbVie– by far the industrys top-selling drug.Alvotechs problem, submitted Tuesday in US District Court for the Eastern District of Virginia, declares that AbbVie has protected an “outrageous number of patents of dubious validity” for Humira that have suppressed competition. Humira comprised 61% of AbbVies profits in 2018 and 43% last year.Gonzalez has really similarly talked up the business future of 2 autoimmune-disease treatments called Skyrizi and Rinvoq, which he believes can change Humira. If Alvotech is successful in challenging Humiras patents, that shift might need to occur even sooner.In May 2020, AbbVie closed a $63 billion acquisition of Botox-maker Allergan, reducing AbbVies dependence on Humira. Humira made up 61% of AbbVies earnings in 2018 and 43% last year.Gonzalez has actually also talked up the business future of 2 autoimmune-disease treatments called Skyrizi and Rinvoq, which he thinks can change Humira.

Home Committee on Oversight and Reform.

Alvotech.

Your House Committee on Oversight and Reforms evaluation into AbbVies pricing practices found 27 rate walkings on Humira given that its 2003 launch.

AbbVie, the maker of the mega-blockbuster drug Humira, is handling a new threat of competitors.
Alvotech is taking legal action versus AbbVie, intending to soon release a copycat version of Humira in the United States.
The battle is brewing as Congress grilled AbbVies CEO over the business drug-pricing strategies.
AbbVies patent practices have actually stood out of legislators. Your Home Committee on Oversight and Reform launched a 57-page report about AbbVies rates and patenting techniques on Tuesday prior to questioning Gonzalez. The congressional investigation discovered AbbVie treked the cost of Humira 27 times since its launch, with a years supply now costing about $78,000– a 470% increase given that 2003.