Biocon Biologics at AAO 2024: Uwe Gudat in an Invigorating Discussion with PharmaShots

Shots:

At the American Academy of Ophthalmology (AAO 2024), Biocon Biologics announced promising results from the extension study of its proposed biosimilar to aflibercept, MYL-1701P

The study demonstrated comparable safety, efficacy, and immunogenicity between patients continuing MYL-1701P and those who switched from aflibercept to MYL-1701P

Biocon Biologics' Chief Medical Officer, Uwe Gudat, discusses the groundbreaking findings from the aflibercept switching study

PharmaShots AAO Email Interview – Uwe Gudat, Chief Medical Officer, Biocon Biologics

Saurabh: Could you give us an overview of Biocon Biologics’ mission and how the development of biosimilars like MYL-1701P aligns with the company’s goals in addressing global healthcare needs?

Uwe: Biocon Biologics' mission is to transform patient outcomes by making life changing biologic therapies more affordable and thus more accessible for many patients for whom these otherwise remain out of reach. In so doing Biocon Biologics strives to contribute to equitable and sustainable health care across the globe.

Sight threatening conditions and the associated progressive loss in visual acuity culminating in blindness can materially impact a patient’s autonomy and quality of life. With the global prevalence of age-related macular degeneration (AMD) alone estimated at 196 million people worldwide these illnesses constitute a major public health challenge. For the many patients with AMD and related conditions such as diabetic retinopathy, and retinal vein occlusion effective treatments can be life changing as they maintain visual acuity and prevent blindness. Aflibercept is such an option. The treatment with aflibercept has improved visual acuity and overall patient outcomes, in such patients in controlled clinical trials and routine medical practice fostering confidence among ophthalmologists to incorporate them into their treatment regimens.

Biocon Biologics, by providing a more affordable aflibercept, stands to make a substantial impact on the healthcare landscape. By offering comparable clinical outcomes, in visual acuity measured as best corrected visual acuity (BCVA), this independently developed aflibercept offers the same benefits to patients and practitioners and at the same time contributes to enhanced patient access and sustainability of our health care systems. MYL-1701P aligns with the company’s goals by addressing a pressing need for more affordable treatment options in ophthalmology.

Saurabh: In clinical studies, why is it crucial to observe similar rates of treatment-emergent adverse events (TEAEs) between both the continuation and switch arms?

Uwe: Observing similar rates of treatment-emergent adverse events between both the continuation and switch arms gives patients and their caregivers the confidence that the safety profiles of the two products do not differ in a meaningful way also when a patient is switched from one to the other. Some patients may be concerned that as they move from one treatment to another more possible “side-effects” – synonymous with TEAE - may be seen. The study shows clearly that no such increase occurs.

In the clinical study a total of 7 (13.46%) participants reported 11 ocular TEAEs; 4 (13.79%) subjects in the continuation arm reported 05 ocular TEAEs, and 3 (13.04%) subjects in the switch arm reported 06 ocular TEAEs. The most frequently reported ocular TEAE was eye pain. The incidence of ocular TEAEs was comparable between the two treatments.

Saurabh: Biosimilars like MYL-1701P are seen as vital for enhancing access to affordable treatments. Could you share how Biocon Biologics addresses quality and safety concerns to build trust in these alternatives?

Uwe: Biocon Biologics, a global leader in biologics, is dedicated to ensuring the highest standards of quality and safety in their products. This commitment is pivotal in building trust among patients, healthcare providers, and regulatory bodies.

Biocon Biologics implements stringent quality control measures at every stage of the product lifecycle. From research and development to manufacturing and distribution, the company employs state-of-the-art technologies and best practices to monitor and ensure product integrity. The company adheres to international regulatory standards, including those set by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other global health authorities. Biocon Biologics has a robust pharmacovigilance system in place to monitor the safety of their products post-launch. This system involves continuous monitoring of adverse events and a thorough analysis of safety data. The company maintains an open communication channel with healthcare providers and patients to promptly address any safety concerns that may arise.

In conclusion, Biocon Biologics' unwavering commitment to quality and safety is integral to building trust in their biological alternatives. Through rigorous quality control, adherence to international standards, robust pharmacovigilance, patient-centric initiatives, collaborative efforts, continuous innovation, and transparent communication, Biocon Biologics ensures its products meet the highest safety and efficacy standards, fostering trust and confidence among all stakeholders.

Saurabh: Regarding MYL-1701P, how did the adjusted mean difference in Best Corrected Visual Acuity (BCVA) outcomes between the switch and continuation groups reinforce its viability as a biosimilar?

Uwe: Biocon Biologics aflibercept offers patients and their caregivers the same clinical benefits as confirmed by the assessment of the best corrected visual acuity (BCVA). This equivalence in treatment benefit is maintained irrespective of whether a patient was treated continuously or switched from the reference product. Continuity of benefit is assured even if patients are switched. This adds to the evidential support for the product.

Demonstration of comparable BCVA outcomes in the switch and continuation groups reinforces that patients can count on comparable benefits in the various settings in which Biocon Biologics aflibercept may be used.

Saurabh: With MYL-1701P now approved by the FDA and introduced in the UK, EU, and Canada and other markets, what strategies does Biocon Biologics have for expanding further in the global ophthalmology market?

Uwe: Biocon Biologics is expanding into ophthalmology, adding a new therapeutic area to our global portfolio. In the U.S., this builds on the company’s experience with Part B biosimilars and is aligned to our existing approach to the market. By leveraging our strengths in commercial excellence, manufacturing, and supply chain integration we aim to bring world-class ophthalmology products to patients in the U.S., Canada, Europe, and beyond.

Saurabh: Is Biocon Biologics planning to go for interchangeability approval for MYL-1701P with Eylea?

Uwe: Biocon Biologics is currently evaluating its options in this regard. The regulatory position on the interchangeability designation has recently evolved as documented by corresponding US FDA guidance. In addition, repeated switches that are the subject of the interchangeability designation may not reflect clinical practice in the setting of intravitreal therapy. Furthermore, the induction of systemic anti-drug antibodies considered to be potential mediators of carry-over effects from one therapy to another are less likely to play role when injecting a biologic into a remote compartment as the eye.

Image Source: Canva

About the Author:

Uwe Gudat

Dr. Uwe Gudat is the Chief Medical Officer at Biocon Biologics, overseeing Clinical Development, Medical Affairs, Pharmacovigilance, and Drug Safety. With over 10 years in biosimilars and nearly 30 years in the pharmaceutical industry, he plays a key role in advancing Biocon Biologics’ clinical strategies, ensuring smooth regulatory approvals and commercial success.

He establishes scientific relations in the U.S. and EU, forming advisory boards for pipeline products while ensuring compliance in Pharmacovigilance and Clinical Development. Passionate about technology, he drives medical education and patient outreach through digital platforms.

Previously, he was CMO at Aretaeus Sarl, focusing on diabetes and obesity drug development. He has held leadership roles at Eli Lilly, Actelion, Novartis, Merck KGaA, and Fresenius Kabi. A specialist in internal medicine and metabolic disorders, Uwe earned his M.D. from Philipps University, Marburg, and trained under Prof. Michael Berger at the WHO Collaborating Center for Diabetes Education.