Company Touts Potential Benefits of Orally Administered Biosimilars, But Are They Likely?

This week, Frost & Sullivan—a global researching and consulting organization—together with Rani Therapeutics, a drug manufacturer developing an approach to the oral delivery of large-molecule drugs, announced the results of a combined research study. The study suggested that biosimilar developers could gain market share from brand-name biologics by developing the biosimilars in oral form.

The research included a survey of more than 500 patients, and more than 100 physicians, including rheumatologists and gastroenterologists. The survey found that 88% of patients and 86% of rheumatologists and gastroenterologists would likely switch from adalimumab (Humira) injections to once-daily pills if an effective oral alternative existed.

Additionally, the results of the study found that such an oral drug could increase patient compliance with treatment. This factor is especially notable in light of the survey’s finding that 62% of patients and 86% of physicians reported that patients either skip or consistently fail to inject the drug as prescribed.

“Humira is the number 1 selling drug in the world, yet this research shows that its sales and AbbVie’s revenues could potentially be threatened by oral adalimumab because of fear of needles and the associated lack of patient compliance. Combine those challenges with patent expiration and the increasing threat of biosimilars, which are forecast to hit the market in the coming years, and it’s the perfect storm,” said Mir Imran, chairman and CEO of Rani Therapeutics, in a statement.

However, the companies did not address the key question of whether regulatory bodies like the FDA or the European Medicines Agency would approve such an orally administered drug as a biosimilar of an injectable or infusible reference product, as such a drug would not be similar in its route of administration, and challenges with interchangeability (and therefore pharmacy-level substitution for the reference product) would be likely.

Rani Therapeutics is not the first drug maker to see the value in an orally delivered biologic, however. Just last month, Protalix BioTherapeutics, Inc, an Israel-based drug manufacturer, announced positive results from a phase 2 clinical trial for its own novel, orally administered anti-tumor necrosis factor (anti-TNF) drug, OPRX-106, for the treatment of inflammatory bowel disease.