50 of 2021’s best-selling pharmaceuticals

Drug sales in 2021 hit record heights, with a handful of pharmaceutical companies handsomely rewarded for creating COVID-19 vaccines and treatments.

Pfizer alone raked in $36.9 billion in sales from the Comirnaty vaccine it developed jointly with BioNTech. Demand for the COVID-19 vaccine helped catapult Pfizer to be 2021’s top pharmaceutical company. Continued demand for the Pfizer-BioNTech vaccine is likely to keep Pfizer as the biggest pharma firm of 2022 as well. (Look out for more insights from our annual Pharma 50 report.) 

The second-best-selling drug of 2021 was AbbVie’s injectable biologic Humira, which generated $20.7 billion in sales. Next in line was Moderna’s COVID-19 vaccine, which drove $17.7 billion in revenue. Merck’s megablockbuster Keytruda rounded out the top four with $17.2 billion in revenue.

Novartis and Roche have struggled to commercialize COVID-19 therapies, although the latter has introduced a series of SARS-CoV-2 diagnostics. T…

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AbbVie settles Humira-related litigation with Alvotech 

AbbVie (NYSE:ABBV) has announced that it has resolved U.S. litigation related to Humira (adalimumab) involving Alvotech Holdings (Reykjavik, Iceland).

The two companies have reached an agreement that will give Alvotech a non-exclusive license to AbbVie’s Humira-related patents in the U.S. starting July 1, 2023.

Under the terms of the agreement, Alvotech will pay royalties to AbbVie to license Humira patents.

In 2020, Alvotech announced that the FDA was reviewing a biologics license application related to a proposed Humira biosimilar known as AVT02. In September 2021, FDA announced that it had delayed its review of the biosimilar candidate.

On February 28, Alvotech announced that FDA had accepted Alvotech’s  biologic licensing application (BLA) for ATV02 with new data supporting interchangeability between ATV02 and Humira.

“We aim to be the first interchangeable, high-concentration biosimilar to this critical treatment,” said Robert We…

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FDA approves first interchangeable Humira biosimilar to Humira

Last year, Humira (adalimumab) was the top-selling drug in the U.S., racking up nearly $20 billion in international sales.

Now, Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) has become the first interchangeable Humira biosimilar.

First winning FDA approval in August 2017, Cyltezo is a tumor necrosis factor blocker indicated for everything from arthritis to Crohn’s, ulcerative colitis and plaque psoriasis.

The FDA decided to grant interchangeable status to Cyltezo based on Phase 3 randomized VOLTAIRE-X clinical trial.

FDA allows interchangeable biosimilars to be substituted for the reference product without the prescriber modifying the prescription.

“We are proud to be the company driving the advancement of biosimilars and delivering the first and only Interchangeable biosimilar with Humira,” said Thomas Seck, senior vice president, medicine and regulatory affairs at Boehringer Ingelheim, in a statement. “The Interchangeability status of …

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Coherus files BLA for Lucentis biosimilar

Coherus BioSciences (NSDQ:CHRS) has announced that FDA has accepted for review the 351(k) Biologics License Application (BLA) for CHS-201, a biosimilar candidate referencing the blood vessel growth inhibitor Lucentis (ranibizumab).

Developed by Genentech, Lucentis first won FDA approval in 2006 to treat wet age-related macular degeneration. Other indications followed, including macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy and myopic choroidal neovascularization.

FDA has chosen August 2, 2022, as the Biosimilar User Fee Act action date for CHS 201.

Besides CHS-201, Coherus has a range of other biosimilars in its portfolio.

In 2019, it won FDA backing for Udenyca (pegfilgrastim-cbqv), a pegfilgrastim biosimilar used to decrease the incidence of infection. The FDA label for the drug describes its use in treating patients with non-myeloid malignancies who receive myelosuppressive anti-cancer drugs.

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AbbVie faces Senate questions related to tax practices

Senate Finance Committee Chair Ron Wyden (D-Ore.) has announced an investigation of AbbVie’s (NYSE: ABBV) tax practices.

In a statement, the senator argued that the company’s tax rate from 2018 to 2020 was 9.5% — less than half of the 20% rate it paid in 2016.

Wyden has sent a letter to AbbVie CEO Richard Gonzalez seeking information about the company’s tax practices.

In the letter, Wyden questioned why the company reported a U.S. pretax loss of $4.5 billion while an offshore pretax profit of $7.9 billion in 2020. “Despite the United States market being the source of most of AbbVie’s revenues and richest price premiums, it appears that the company has consistently reported net losses in the United States while reporting substantial foreign profits,” he wrote.

AbbVie did not immediately respond to a request for comment regarding Wyden’s investigation.

AbbVie is also the subject of a May report from the House Committee on Oversight and Reform…

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House report accuses AbbVie of price gouging

A recent report from the House Oversight and Reform Committee concluded that AbbVie (NYSE:ABBV) aggressively increased prices of popular drugs, including the bestseller Humira (adalimumab), which brought in close to $20 billion last year. Approximately $16 billion of those sales were in the U.S.

In recent years, the company also repeatedly increased the price of the small-molecule drug Imbruvica (ibrutinib), according to the report, which is the result of a two-year investigation. AbbVie jointly markets Imbruvica with Janssen (NYSE:JNJ).

An annual supply of Humira costs approximately $77,000, while a year’s worth of Imbruvica is $181,529, according to the House report. The price of the latter has increased 82% since the drug launched in 2013. Outside of the U.S., the cost of Humira has fallen in recent years.

“AbbVie pursued a variety of tactics to increase drug sales while raising prices for Americans, including exploiting the patent system to extend it…

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AbbVie accuses Alvotech of stealing Humira trade secrets 

In a complaint filed in Illinois federal court, AbbVie alleges that the Icelandic biopharma company Alvotech sought to copy its blockbuster biologic Humira (adalimumab). 

The lawsuit accuses Alvotech of hiring a former AbbVie employee, Rongzan Ho, to help it develop a copycat version of Humira. 

Ho, a team leader of upstream manufacturing for Humira, was well-versed in the processes involved in manufacturing the drug. 

Ho relayed to AbbVie in an exit interview that he was leaving “mainly to learn single-use bioreactors and other new technologies.”

Ho left AbbVie in 2018 to join Alvotech and provided the company with proprietary spreadsheets, according to the complaint, which also accuses Alvotech of poaching other former AbbVie employees.  

In November, Alvotech announced that the FDA had accepted its biologics license application to review its proposed Humira biosimilar. “AVT02 is highly similar to its reference product in terms of structu…

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