Shots:
- The United States has about 38.4 million people living with diabetes, representing 11.6% of the total population. With growing prevalence, there is a significant unmet need for affordable diabetes medications.
- Biocon Biologics recently announced the FDA approval of Kirsty, the first and only interchangeable biosimilar to NovoLog (Insulin Aspart).
- Joshua Salsi, the Head of North America Commercial at Biocon Biologics, discusses the company’s insulin portfolio, Kirsty’s clinical study design, and potential future approvals.
Saurabh: Welcome to PharmaShots Viewpoint and congratulations on making Kirsty’s way to the US market, as the first and only interchangeable biosimilar to NovoLog (Insulin Aspart)! Given the staggering diabetic prevalence in the US, how is the approval going to shape diabetes care in the country?
Joshua: Biosimilar insulins are an increasingly important resource to manage diabetes in the U.S. and around the world. As global demand is increasing, we are seeing competitors exiting the market, creating supply constraints and leaving patients with access issues. Biosimilar insulins, like Kirsty, will be a long-term solution for patients to access high-quality biologic therapies.
Saurabh: Remarkable! Would you mind shedding light on the study design, highlighting the safety, efficacy, and immunogenicity profiles?
Joshua: The approval of KIRSTY was based on a comprehensive package of analytical, nonclinical and clinical data. Kirsty as an interchangeable biosimilars has met the same high standard of biosimilarity for FDA approval. This means you can expect the same safety and effectiveness over your course of treatment as you would from the reference product.
Saurabh: The FDA’s nod adds yet another product to Biocon Biologics’ insulin portfolio after the approval of Semglee in 2021. What other diabetic biosimilars are anticipated to hit the US market this year and next?
Joshua: Biocon’s Semglee was approved by the U.S. FDA in June 2020 and later received approval as the first interchangeable biosimilar insulin in July 2021.
We can’t speak specifically to other companies’ plans; however, we do know that 3-4 companies have expressed an interest in eventually developing a biosimilar Insulin Aspart. However, as of our FDA approval, Kirsty was authorized as the first and only interchangeable rapid-acting Insulin Aspart. Aspart is a strategic asset that strengthens and expands our diabetes franchise alongside our already leading Semglee (Insulin Glargine).
Saurabh: What clinical and regulatory challenges did you face, and how did you overcome them while developing Kirsty?
Joshua: Biocon Biologics understands the diabetic crisis worldwide and is dedicated to providing patients with their insulins and continuing our investments in scaling-up insulin manufacturing to meet the year-over-year demand increases worldwide. We also continue to work with the FDA to ensure there is a robust supply chain for insulin products. We do this with all Biocon products.
Saurabh: What other markets are you targeting globally for Kirsty, and how have the developments been so far?
Joshua: Kirsty has been approved in 45 countries and is already commercialized outside of the United States, including in Europe, Canada and other markets.
Saurabh: Do you have any PDUFA dates for your investigational biosimilars this year?
Joshua: Biocon Biologics is in the process of launching five biosimilar products in the next 12-18 months. In the United States, this includes the recently launched Yesintek (Ustekinumab) and Kirsty (Insulin Aspart). Additionally, Yesafili (Aflibercept) and Jobevne (Bevacizumab) have both been approved by the FDA already and are pending U.S. launches. Yesafili was recently approved by Health Canada and launched in Canada. Finally, we are pursuing approval of Denosumab for both bone health and oncology. We will continue to focus on bringing access and affordability of biosimilars to the Global markets.
Saurabh: Are you looking for collaborations to expand your biosimilars portfolio and unlock commercialization opportunities in other markets?
Joshua: Biocon Biologics has a market strategy that includes both self-led commercialized products, along with collaborative partnerships. The Company seeks out and evaluates opportunities that are aligned with our market strategy and maximize value to our key stakeholders.
Biocon Biologics has a partnership to produce Insulin Aspart Drug Substance for Civica, Inc., a U.S.-based not-for-profit pharmaceutical company. This collaboration, which further expands our insulin business, access, and affordability to patients, is at the core of our foundation for growth. With our vertically integrated business model, we are among the few companies positioned to operate as both a contract manufacturer and a commercial player, creating multiple revenue opportunities, but also using the right model to get patients access to affordable medicines.
About the Author:
Joshua Salsi
Head of North America, Biocon Biologics
Joshua Salsi is the Head of North America at Biocon Biologics. As a healthcare leader, Josh has spent his 20+ year career building and leading teams focused on improving access, affordability and overall patient utility of pharmaceuticals.
Prior to joining Biocon Biologics, Josh was Vice President, Head of Oncology and Biosimilars at Viatris (formerly Mylan). From 2002 to 2015, Josh held various commercial positions at Pfizer, predominantly in their Specialty and Oncology businesses.
Related Post: Enhancing Accessibility to Medicine: Joshua Salsi from Biocon Biologics in Conversation with PharmaShots
