The Top 5 Biosimilars Legal Stories of 2021

The top legal stories in biosimilars over the past year concerned etanercept and adalimumab biosimilars and access to insulin.

The year 2021 ended with a final decision in the case of Immunex v Samsung Bioepis regarding their dispute over etanercept (Enbrel) patents, with a ruling in favor of the reference drug companies, which included Immunex, Amgen, and Roche.

Enbrel is indicated for the treatment of autoimmune disease, specifically rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and juvenile idiopathic arthritis.

The upshot was that Samsung Bioepis effectively will not be able to bring its etanercept biosimilar (Eticovo) to the US market until 2029.

Samsung Bioepis was permanently enjoined from “making, using, offering to sell, or selling within the United States, or importing into the United States any product containing etanercept,” according to the ruling.

The mandate will end when 2 key patents for etanercept expire on April 24, 2029, meaning another 7 years before biosimilars can offer competition for Enbrel and potentially bring down prices. According to a report from SingleCare in 2019, the cost of a month’s supply of Enbrel was $4945, putting this drug third from the top of the 10 most costly drugs in the United States. The others were Afinitor (everolimus; cancer) and Humira (adalimumab; inflammation).

The reference product earned $5 billion for Amgen in revenues in 2020, most of it from the US market.

There is one other FDA approved biosimilar for etanercept, and that is a Sandoz product (Erelzi). This has also been warehoused owing to unsuccessful patent litigation. In May 2021, in another setback for Enbrel biosimilars, the US Supreme Court declined to reopen a Federal Circuit case concerning an etanercept patent dispute between Sandoz and the reference companies.

“We are disappointed the Supreme Court decided not to review our case,” said Keren Haruvi, president of Sandoz US and head of the company’s North America operations.

Adalimumab Litigation

Separately, multiple court actions were playing out between AbbVie, maker of Humira, and Alvotech, a Reykjavik, Iceland, company that hopes to bring an adalimumab biosimilar (AVT02) to market by 2023.

Apart from the litigation, Alvotech has good story to tell its investors. The company has developed a high concentration, citrate-free version of adalimumab, which could improve patient adherence and potentially make this more competitive than some other adalimumab biosimilars already approved, and in the United States it could be earlier to market than most adalimumab biosimilars. It has also obtained European Commission approval (November 2021) for commercialization in EU countries.

However, in the United States, Alvotech must free its biosimilar candidate from entangling litigation, which mars the good business proposition of the high concentration biosimilar. The company is headlocked in a yearlong litigation process with AbbVie over patents that may be infringed if AVT02 comes to market, and this court review will likely stretch to at least October 2022.

There is one other US-based struggle underway in the court system, and that involves allegations from AbbVie that Alvotech had help it shouldn’t have had in developing the manufacturing process for AVT02; namely, that an employee of AbbVie’s Singapore offices stole confidential manufacturing information and went to work for Alvotech in setting up an adalimumab production line for that company. Alvotech contends that didn't happen, and the case is now before the US International Trade Commission.

Although Alvotech has approval to launch in the European Union, the company has not announced a launch date and it remains unclear whether AbbVie is attempting to prevent an EU launch from happening.

Lynn Fitch, Mississippi Attorney General

Diabetes is an epidemic in Mississippi.

Meanwhile, for Alvotech, the stakes in this contest with the reference drug manufacturer are high. Alvotech recently lined up a $450 million investment from a consortium of companies and announced plans to go public. AVT02 is the nearest drug to commercialization in its pipeline and potentially the most lucrative, so a major letdown in the legal arena could have consequences for the success of these other business dealings.

There is one other high concentration, citrate-free adalimumab biosimilar approved in Europe: Celltrion Healthcare’s Yuflyma, which has already begun commercialization.

Insulin Litigation

In another landmark case that has implications for biosimilars, the state of Mississippi filed suit against the 3 top incumbent insulin producers: Eli Lilly, Novo Nordisk, and Sanofi-Aventis, as well as pharmacy benefit managers that contract with those producers.

Despite a century of insulin availability, the price of treatment remains stubbornly high, and in Mississippi the cost of treating state residents is $3.5 billion annually, according to state Attorney General Lynn Fitch. “As a mother of a diabetic, I know the emotional, physical, and financial toll the unacceptable price of insulin has on families,” she stated in a recent interview with the Mississippi Center for Investigative Reporting.

The civil suit was filed in Hinds County Chancery Court in Jackson, Mississippi, and contends that the defendants are running an “insulin pricing scheme” with the aim of gouging patients and payers for the sake of profits.

The first insulin biosimilar (Semglee, insulin glargine) was approved in 2021, and this could have a downward effect on pricing in 2022. Indeed, regulators in the United States are hoping that a newly opened regulatory pathway for insulin biosimilars could help to spur insulin discounting and broaden access and affordability for patients. That pathway opened in 2020 via the Biologics Price Competition and Innovation Act.

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