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Boehringer’s Interchangeable Tag for Humira Biosim Is a ‘landmark’ Win for the Field: Analyst Feedzy

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Even after many biosimilar players inked patent settlements with Humira maker AbbVie, Boehringer Ingelheim held out to challenge AbbVie’s “patent thicket” in court. Although Boehringer eventually settled, the company’s copycat has now scored an “interchangeable” designation–a landmark development that shows it could be a formidable competitor, one analyst writes.

Boehringer on Friday said its drug Cyltezo had scored FDA approval as the first interchangeable Humira biosimilar. Boehringer can’t launch until July 1, 2023, under its patent settlement with AbbVie, but when it does, the designation means pharmacists can substitute Cyltezo for Humira at the pharmacy counter.

Until now, every biosimilar approved has needed a prescription specifically for that biosimilar itself. Interchangeability means biosimilars can be treated like small-molecule generics, subbing in for their reference brands at will.

So, the approval isn’t only important for the Humira biosimilar market, Bernstein analyst Ronny Gal pointed out to clients Monday. It’s a “landmark achievement” for the entire field because it’s the first interchangeable monoclonal antibody–and most drugs that biosimilars target are monoclonal antibodies, or mAbs. The news shows the FDA has now established requirements for interchangeable approvals.

“This will facilitate future approvals for other drugs, and we wonder if in the long run, interchangeable biosimilars will be the only biosimilars” for mAb drugs, he added.

RELATED: Boehringer buckles in AbbVie patent fight, saving Humira from biosims until 2023

Meanwhile, specific to the Humira market, Gal said Boehringer “should not be under-appreciated” because it has “significant biological manufacturing and U.S. commercial capacities.” In the U.S., Boehringer Ingelheim has thousands of employees and a manufacturing presence in Fremont, California. The company also just opened a massive production site in Austria.

But Boehringer won’t be the first to access the lucrative U.S. Humira market. Under a 2017 deal, Amgen appears to be set up to launch the first Humira biosimilar on January 31, 2023. Merck and partner Samsung Bioepis negotiated a license that starts on June 30 of that year. Boehringer could follow up a day later. AbbVie’s blockbuster generated more than $16 billion in the U.S. last year, indicating the size of the market at stake.

RELATED: Alvotech scores in AbbVie trade secrets case, but the Humira patent fight will stretch into next year

One holdout still aims to challenge AbbVie’s patents in court. Iceland’s Alvotech is locked in a lawsuit with AbbVie, and the court aims to rule on that case by the end of next October. Alvotech is also pursuing an interchangeable designation and has completed a successful switching study for its candidate.

Source Here: fiercepharma.com

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You Say Trintellix, I Say Brintellix: Why a Drug Name in the US Won’t Always Translate Across the Pond Feedzy

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As a British citizen living in England but writing on American drug names, I’m in a perfect position to know that many drugs approved in Europe and the U.K. can have very different names from those in the U.S.

Why is that? Well, to find out, Fierce Pharma Marketing sat down with Scott Piergrossi, president of creative at the Brand Institute, a company that has helped name some of the world’s biggest drugs. He’s not explaining the reasoning behind any drug name changes mentioned in this piece, but offering up insight into why different regions may need tweaks–or complete rethinks–in branding for the same drug.

Often, the change in name can be very minor. Let’s take Amgen’s new non-small cell lung cancer drug as an example: In the U.S., the FDA approved the drug as Lumakras, but in in Europe, its counterparts at the European Medicines Agency approved the med as Lumykras earlier this month.

RELATED: Surprise! Amgen’s hot KRAS drug seals early FDA approval, winning a shot against ‘undruggable’ cancer

You’ll see this U.S.-Europe divide a lot with drug names–but why? Piergrossi explains that changing a single letter can often provide enough differentiation to satisfy regulatory requirements, which can be different in the U.S. and Europe, “such as changing a vowel to a y, or adding/removing a letter or two.” Just as we see with Lumakras/Lumykras.

Another key reason an agency might reject a name is if they think the name is overly promotional–what the FDA refers to as “misbranding,” such as making misrepresentations about safety or efficacy. Hence, you don’t have antivirals called KillsCOVIDNoSideEffects.

Some examples can seem obvious, but Piergrossi explains there can be more subtle and subjective naming differences that create misleading suggestions in a name.

Take the FDA-approved osteoporosis drug Boniva. In Europe and elsewhere, the drug is sold under the brand name Bonviva. “The latter perhaps suggesting ‘good life’ more so than the former,” Piergrossi says, though he adds that extracting meaning from an invented name, in his experience, is “highly subjective.”

RELATED: Brintellix? Nope, Trintellix. Takeda rebrands to end name confusion

There’s also the rare example of a change mandated after the agency has approved a drug and its name. We saw this with Trintellix, an antidepressant from Takeda and Lundbeck. That’s its newer name: Originally approved as Brintellix, the drug had to change–per the FDA–given that name’s similarity to AstraZeneca’s anti-blood-clotting therapy, Brilinta. Prescribers were actually confusing the two brands, triggering medication errors. Brintellix still bears that name in Europe and elsewhere.

Sometimes, it just comes down to regional preferences at a company. Global pharmas have global teams working on product marketing and name development. “A regional team might prefer one spelling versus another, assuming they are given the latitude to make those decisions, so the name is modified accordingly,” said Piergrossi.

Original Article: fiercepharma.com

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GlaxoSmithKline Rushes to Accelerate COVID-19 Antibody Output Amid Omicron-driven Demand Feedzy

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GlaxoSmithKline and Vir Biotechnology are rushing to speed up production of their COVID-19 therapy, now that they’re the only companies with an antibody that appears to be truly effective against omicron.

The FDA on Dec. 30 cleared a Samsung Biologics site as a second manufacturing facility to make GSK and Vir’s Xevudy (sotrovimab), a GSK spokesperson told Fierce Pharma.

Along with adding the new facility, GSK and Vir worked with external partners to secure additional batches of drug substance to support supply this year, the spokesperson said via email.

GSK had been planning to commission a new production facility to scale up production and establish a second manufacturing site amid pandemic uncertainty, the spokesperson said. But omicron’s emergence suddenly pushed the acceleration button.

GSK and Vir recently found that sotrovimab retains its strength against omicron in cell cultures, while lab data showed that Eli Lilly’s antibody combo of bamlanivimab and etesevimab and Regeneron’s REGEN-COV cocktail are unlikely to be able to tackle the new variant.

That means, among the three FDA-authorized antibody drugs to treat infected patients, only sotrovimab is still powerful enough to fight omicron. AstraZeneca’s Evusheld is authorized as a prevention method for immuno-compromised people.

RELATED: GlaxoSmithKline and Vir’s sotrovimab stands up to omicron despite other COVID antibodies falling short

After those lab tests, the U.S. government in December temporarily halted distribution of Lilly’s and Regeneron’s offerings. Although the two products are now shipping again, their ability to fight the now-dominant omicron remains questionable.

Demand naturally started to shift to Xevudy. Last week, the Biden administration signed a deal to buy 600,000 additional doses for distribution this quarter.

“We were on the phone with the U.S. government immediately, sharing the data, discussing what was possible from a supply perspective,” said Bart Murray, who leads GSK’s COVID operation in the U.S., as quoted by The Wall Street Journal.

Other countries have also been snagging supplies of Xevudy. A few days ago, Canada signed on for 20,000 doses. GSK also has agreements with Japan, U.K., Singapore, Australia and others. All told,

GSK and Vir have said they expect to manufacture about 2 million doses globally in the first half of 2022.

RELATED: GSK, Vir file for emergency FDA authorization of intramuscular formulation of COVID-19 antibody

Before the new deal, GSK had delivered the 440,000 doses it agreed to supply to the U.S. in 2021. The government is still allocating that supply to healthcare facilities. The company now expects to start shipping the 600,000 doses in February and March, the spokesperson said.

Both Regeneron and Eli Lilly have started developing new antibody treatments that could neutralize omicron.

Meanwhile, China’s Brii Biosciences is seeking an FDA green light for its antibody combo of amubarvimab and romlusevimab, which won Chinese approval in December. The company recently said its cocktail also held up against omicron. The U.S. doesn’t yet have any supply agreement with Brii.

Article: fiercepharma.com

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Fierce JPM Week: Bristol Myers’ Next-gen Autoimmune Med Not Just Another JAK Drug, Exec Says Feedzy

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After a high-profile study turned up safety risks for Pfizer’s JAK inhibitor Xeljanz last year, the FDA put the entire class under a microscope–and it only recently went back to granting new approvals in that class. Bristol Myers Squibb, meanwhile, has a new candidate that the company’s chief medical officer says is safer than the other JAKs.

Speaking during the Fierce JPM Week virtual conference, Bristol’s CMO, Samit Hirawat, said the company’s deucravacitinib is a novel TYK2 inhibitor “with a very specific downstream effect of integrating IL-12, IL-23 and interferon and sparing other cytokines and sparing JAK 1, 2 and 3.”

While Bristol aims to highlight its med’s differences from drugs in the JAK class, TYK2 is known colloquially as JAK4 and is part of the Janus kinase family. That has some industry watchers worried that the FDA may take a tough stance on the candidate amid safety concerns for the larger drug class.

After an FDA submission last year, deucravacitinib is under review to treat moderate to severe plaque psoriasis. The agency’s decision deadline is set for Sept. 10, 2022.

So far in deucravacitinib’s studies, BMS doesn’t “see the hematologic impact that JAK inhibitors do show [and] we don’t see the dysfunction in the liver enzymes that is seen with JAK inhibitors,” Hirawat said during Fierce JPM Week.

Further, “we don’t see dyslipidemia that is shown by JAK inhibitors,” Hirawat added.

Since Xeljanz post-marketing study showed heightened risks of cardiovascular problems and cancer, the FDA has put the entire JAK inhibitor class in a protracted safety review. That process triggered missed approval deadlines for new drug candidates and delayed label expansions for existing meds.

More recently, the FDA started giving new blessings for JAK drugs–but under the condition that they’re used behind old-school TNF inhibitors such as Humira. Pfizer’s new Cibinqo and AbbVie’s Rinvoq recently won eczema approvals, for instance.

RELATED: Bristol Myers Squibb’s next-gen autoimmune med starts high-stakes FDA review amid classwide JAK scrutiny

As for deucravacitinib, Hirawat said the Poetyk PSO-1 and Poetyk PSO-2 studies–plus trials in Japan and China–show that the med is a “first-in-class” medicine, apparently hoping to differentiate the drug from existing meds at the center of the FDA safety review.

When Bristol bought Celgene for $74 billion back in early 2019, the company had to sell the lucrative psoriasis drug Otezla to score antitrust approval for the deal. The company opted to stick with deucravacitinib, which later beat Otezla in the Poetyk studies by helping more patients achieve 75% skin clearance.

These days, Amgen markets Otezla and is generating blockbuster sales from the psoriasis medicine. For its part, Bristol figures deucravacitinib can generate $4 billion at peak.

And deucravacitinib has some other new indications in the works. BMS is “looking forward to seeing the data imminently” for a phase 2 trial in systemic lupus erythematosus, Hirawat said. If that result is “supportive,” BMS will launch a phase 3 program, he said.

RELATED: Bristol Myers Squibb’s deucravacitinib flunks midphase IBD trial, raising questions about potential blockbuster

Meanwhile, the drug didn’t meet proof of concept criteria in inflammatory bowel disease last October, but Hirawat said the company is running two studies with higher doses and is “absolutely” committed in that disease. With those results, the company expects to have more information about potential indications to “pursue in the future,” Hirawat said.

Source: fiercepharma.com

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