Biosimilar adoption is ramping up in the U.S., and biosimilars have already found wide use in Europe since they were first introduced there in 2006.
Growing biosimilar adoption, however, do more than chip away at biologics revenue — they often fuel price erosion. An IQVIA report concluded that biosimilar use in Europe enabled €5.7 billion in savings in 2020. In the U.S., biosimilar adoption remains at an earlier stage, but the biosimilars threaten to significantly alter the domestic biologics market.
Earlier this year, FDA accepted Alvotech’s biologic licensing application for ATV02, a biomsiliar based on AbbVie’s Humira (adalimumab). Humira remains one of the best-selling drugs on the marketplace, currently generating in more than $20 billion in global sales annually.
The robopill maker Rani Therapeutics sees an opportunity in the erosion. The company’s CEO, Talat Imran, believes biologics companies can stand out by giving patients the option of oral delivery, thus differentiating themselves from biosimilar competitors.
Conversely, biosimilar companies could enter a race to the bottom. “There’s an inverse relationship between how much you cut the drug and how many more patients you need to make it worthwhile from a revenue perspective,” Imran said. “That’s kind of a losing equation.”
Talat says that oral biologics could bolster medication compliance and improve outcomes and greater convenience for patients.
The company’s first-generation robotic Rani pill can deploy a biologic into the small intestine, delivering the equivalent of 3 mg of drug with bioavailability similar to subcutaneous injections.
The company is also working on the RaniPill HC, a high-capacity version that can deliver up to 20 mg of drug.
“It’s a quantum leap for us,” Imran said, “Now, the overwhelming majority of biologics can fit in that RaniPill.” In addition, the company expects the larger size can accommodate virtually all immunology drugs as well as many drugs for oncology and rare diseases.
In tests with AbbVie’s megablockbuster Humira, the RaniPill HC achieved high bioavailability.
Imran envisions a future when many patients taking infusions of biologics can take pill-based versions of them rather than go to an infusion center. “If you’re on a monotherapy and sick with cancer, I would rather have those patients at home,” Imran said. Doing so could bolster compliance and convenience.”
Daily administration of pill-based biologics could also have pharmacokinetic advantages. “When you give infrequent doses of drugs, you have big peaks and big troughs,” Imran said. “Whereas if you want to be at the top level with a daily dose, we can tune it so that you stay at the higher level of drug exposure.”
Daily pill-based doses could also help patients on, say, an oncology drug have a lower level of it in their bloodstream to reduce adverse events. “But nobody’s getting an infusion every day because that’s just not realistic,” Imran said.
Imran believes that Rani’s technology could work for the majority of monotherapies. “Now, there are some edge cases — people on polytherapies where they are taking different cocktails of drugs,” Talat acknowledged. “In cases like that, you may have to go out and get an infusion.”
Rani Therapeutics also believes that its technology could open up biologics access to patients earlier. “We want to become the first-line biologics company,” Imran said. “By that, I mean that patients will start on cheap, easy to prescribe oral small molecules virtually in any category.” Examples include bisphosphonate for osteoporosis, methotrexate for arthritis and metformin for diabetes. “Ultimately, you have to move on to a biologic as the disease progresses in most of these categories,” he said. “If we have an oral biologic in one of these categories, our assumption is patients will filter through us before they move on to anything else and that we can start patients on these therapies earlier so that you don’t wait until they’re so sick that now they absolutely need it.”
Rani Therapeutics’ IP strategy could keep competitors at bay. “Our external patent counsel said we’re in the greenest field he’s ever seen in his career,” Imran said. “Nobody had really thought about using a swallowable auto-injector to deliver a biologic for whatever reason.”
Filed Under: Biologics