rBIO's biosimilar insulin, R-biolin, achieves bioequivalence to Novo Nordisk Novolin® R in animal studies; company prepares for 50x scale-up and readies for in-human studies

Recent price cuts by major insulin manufacturers may appear to address affordability challenges, but they primarily target older insulin drugs nearing patent expiration. This tactic, coupled with the discontinuation of essential insulins like Novo Nordisk Levemir® and a shift in focus towards more profitable GLP-1 drugs, creates a concerning landscape of potential shortages and continued high costs for many patients. 

rBIO, a biotechnology company committed to improving insulin access and affordability, is stepping up to fill this gap. Today, the company announced the successful completion of preclinical studies for its first biosimilar insulin, R-biolin, demonstrating bioequivalence to Novolin® R.

"While some celebrate price reductions on older insulins, the reality is that many patients rely on specific formulations that are being phased out or remain prohibitively expensive," said Cameron Owen, CEO of rBIO. "Our mission is to ensure a stable supply of affordable insulin options, starting with our lead biosimilar, R-biolin, and continuing with our next project, a biosimilar to Levemir."

rBIO's commitment to patient needs is evident in its focus on developing biosimilars for discontinued or less profitable insulins. By leveraging innovative production methods, rBIO aims to offer high-quality alternatives at significantly lower costs, challenging the industry's status quo and prioritizing patient well-being over profit maximization.

rBIO achieves scientific milestone in preclinical studies

A first-in-animal study conducted by Innospec, a leading contract research organization, found that R-biolin exhibits similar efficacy in achieving the primary end point of reducing blood glucose level as Novo Nordisk's Novolin® R, one of the leading insulin products on the market. This achievement marks a significant step forward in rBIO's mission to provide affordable insulin to millions of people living with diabetes.

"The Innospec Bioresearch team observed striking similarities between rBIO's insulin and the biological function characteristics of Novolin R, a trusted standard in diabetes management. Early lab results suggest that rBIO's insulin behaves in a highly controlled manner, akin to Novolin, showing promise for comparable efficacy and reliability. Innospec Bioresearch is eager to collaborate further with rBIO, scaling these findings and exploring the potential for broader clinical applications. This partnership could represent a significant step forward in insulin innovation and improved patient outcomes," said Dr. Viswanathan, director, Innospecs Bioresearch.

"rBIO has strategically engaged with multiple partners, including CROs and CDMOs, to rigorously validate and ensure the reproducibility of our expression platform technology. The successful biochemical and biological validation achieved through both in vitro and in vivo studies paves the way for commercial scale-up," said Dr. Deenadayalan Bakthavatsalam, chief scientific officer of rBIO.

rBIO addresses the insulin shortage

The recent discontinuation of Levemir by Novo Nordisk has left many patients, particularly pregnant women, children, and athletes who require a longer-acting basal insulin, searching for alternatives. rBIO is actively developing a Levemir biosimilar to address this critical shortage.

"As a patient advocate, I'm deeply concerned about the industry's focus on profits over patients," said Alison Smart, founder of the Alliance to Protect Insulin Choice. "rBIO's dedication to developing affordable biosimilars offers a much-needed solution to the challenges faced by the diabetes community."

"We recognize the urgent need for a Levemir biosimilar and are committed to bringing a product to market as quickly as possible," added Owen. "Our goal is to ensure that no patient is left without access to the insulin they need. With R-biolin now validated, we are looking for partners to help us achieve scale-up."