Navitas Life Sciences provides the right platform for clinical research excellence, where innovation meets precision. At Navitas Life Sciences, we're at the forefront of revolutionizing clinical research management systems, collaborating seamlessly to drive efficient biosimilar clinical trials to be among the leading pharma CROs.
Kadalmani Krishnan Ph.D.,
General Manager, Levim Biotech
What are biosimilar and interchangeable biologic medications?
Biosimilars represent a category of biologic medications known for their safety and efficacy in treating various illnesses. An interchangeable biosimilar, as defined by applicable laws, adheres to additional requirements, enabling the FDA to grant approval for both biosimilar and interchangeability biosimilars.
An interchangeable biosimilar can be substituted for the original product without prescriber consultation, resembling the routine substitution of generic drugs for brand-name drugs. This practice, termed pharmacy-level substitution, is governed by state pharmacy laws.
Biosimilar Clinical Trial Services for Levim Biotech
Navitas Life Sciences played a pivotal role in supporting Levim Biotech's milestone achievement with a cost-effective Liraglutide biosimilar. Our expertise in operations and regulatory compliance ensured Levim's status as the first biosimilar launch in India, overcoming challenges even amidst a pandemic. In this blog, we met with Kadalmani Krishnan Ph.D., General Manager, Levim Biotech to understand more about our pivotal role in conducting the Biosimilar Clinical Trials for Liraglutide.
Kadalmani Krishnan Ph.D.
General Manager,
Levim Biotech
Please tell us about your professional journey and provide a short glimpse of Levim Biotech
Levim Biotech is a biopharmaceutical firm with a vision to address local and global healthcare problems, in particular the affordability and accessibility of biopharmaceuticals. The research at Levim focuses on recombinant proteins & peptides including biosimilars and developing proprietary drug delivery technologies for acute diseases, oncology & metabolic disorders.
The overall journey of our Liraglutide biosimilar had been very exciting and overwhelming. During which, we have overcome a critical challenge of carrying out acylation of the GLP-1 peptide for producing Liraglutide biosimilar with its innovative process, now granted as a patent in India & USA. Levim has further scaled-up the process & taken the product through complete clinical development including Phase-1 and Phase-3 trials – the only Indian company to have successfully done so. The clinical data was published in Diabetes Research and Clinical Practice with an impact factor 8.1. Secondly, Levim has co-developed indigenous sources for 70% of the manufacturing inputs, including for the pen injection device. The impact of this innovation supported by the funding from NBM, BIRAC translated into a highly cost-effective Liraglutide biosimilar. In India, Levim Launched its Liraglutide biosimilar at the Global Bio-India 2023. Apart from the innovator molecule, Levim Biotech is the first company to launch Liraglutide Biosimilar in India. Levim Biotech is now looking at emerging markets.
Congratulations on the successful launch of liraglutide in India. Please highlight key benefits of the drug and how the clinical trial contributed to the understanding of the drug's effectiveness and safety in Indian adult patients with type 2 diabetes mellitus?
India is regarded as the 'diabetes capital of the world', with 101 million Diabetes patients and about 136 million prediabetes [ICMR-INDIAB report, 2023]. Such high prevalence translates into predisposing the large Indian population to risk of CVD, kidney, foot, eye disease, and obesity. So far, there are no other biosimilar approvals for Liraglutide in India. The clinical data elucidated that Levim's Liraglutide is efficacious and safe for human use. Consequently, it was approved by the CDSCO, India. Glenmark markets the drug under the brand name Lirafit at about 70% lower cost of therapy. It is priced at approximately Rs 100 for a standard daily dose of 1.2 mg. The pricing strategy aims to aid the enhancement of accessibility and affordability of Liraglutide biosimilar and to become the preferred choice by clinicians and T2DM patients. Further, such efforts will contribute to the Nations Make in India movement and address unmet national healthcare needs.
What were some of the challenges Levim Biotech faced in launching the Biosimilar of Liraglutide in India, and how did Navitas Life Sciences aid in overcoming those challenges?
One of the interesting challenges was execution of the study itself amidst the pandemic situation. We needed to ensure compliance with stringent regulatory requirements. Navitas Life Sciences provided invaluable expertise in operations (study execution), also supported Levim Biotech in preparing comprehensive regulatory submissions. Navitas achieved subject recruitment well in advance to expedite trial completion. Secondly, as the clinical trials were jointly funded by Levim Biotech LLP and India’s National Biopharma Mission (NBM), the Biotechnology Industry Research Assistance Council (BIRAC) demanded multi-level stakeholder management, where Navitas remained exceptional. In particular, supported the Clinical Development Services Agency (CDSA), independent auditors and trial monitoring agency appointed by BIRAC. Overall, Navitas operational excellence helped Levim expedite the trial completion and launch the product and becoming the first and the only company to launch Liraglutide biosimilar in India.
Based on your positive experience, what advice would you give to other pharmaceutical companies or research organizations considering Navitas Life Sciences for their clinical trial services?
We have successfully conducted the Ph-1 and Ph-3 trials with Navitas Life Sciences. We found Navitas to be a highly reliable CRO partner with highest standards of integrity. Therefore, I will be more than happy to recommend Navitas Life Sciences for our upcoming clinical trials and to my colleagues in other companies globally.
Strategic Partnership with Navitas Life Sciences
Thirumalaivasan K, Assistant Vice President – CDO, Navitas Life Sciences responded to a few questions to help in understanding the extent of support provided, which will highlight the breadth of our services.
Thirumalaivasan K
Assistant Vice President – CDO,
Navitas Life Sciences
Kindly provide specific instances where Navitas Life Sciences demonstrated exceptional expertise during the critical startup phase of the clinical trial?
Navitas Life Sciences demonstrated remarkable expertise, particularly during the critical start-up phase leading to early First Patient In (FPI). Our team adeptly navigated regulatory complexities, ensuring a swift initiation of the clinical trial. This efficiency in the start-up phase directly contributed to the early achievement of FPI milestones, setting a positive trajectory for the entire trial.
How did Navitas Life Sciences collaborate with principal investigators and other stakeholders to ensure a smooth and efficient process throughout the clinical trial?
Throughout the trial, Navitas Life Sciences maintained robust collaboration with our principal investigators and other stakeholders. Our communication strategies facilitated seamless information flow, quick issue resolution, and efficient decision-making. This collaborative approach played a crucial role in the overall success of our Biosimilar product clinical trial.
What strategies did Navitas Life Sciences employ to ensure adherence to timelines and success of the project?
Meticulous Project Management Approach: Navitas Life Sciences adopts a meticulous project management approach that forms the foundation for the successful execution of our projects. This involves the careful planning, organization, and coordination of resources, tasks, and timelines. Each project is assigned a dedicated project management team with expertise in the specific therapeutic area and regulatory landscape.
Consistent Adherence to Milestones: Clinical Project Manager is committed to ensuring consistent adherence to project milestones. Navitas Life Sciences is equipped with the necessary tools and resources to monitor each milestone closely. Regular assessments are conducted to evaluate progress and identify any potential bottlenecks. This proactive approach allows us to maintain a steady pace and prevent delays.
Regular Reviews for Issue Identification and Resolution: To further ensure project success, Navitas Life Sciences conducts regular reviews at key junctures throughout the project lifecycle. These reviews serve as a platform for the identification and resolution of potential challenges. By addressing issues promptly and collaboratively with stakeholders, we mitigate risks and maintain the project's trajectory towards successful completion.
Stakeholder Collaboration: Navitas Life Sciences recognizes the importance of collaboration with all stakeholders involved in the project. Regular and transparent communication channels are established, fostering an environment where issues can be raised, discussed, and resolved efficiently. This collaborative approach enhances our ability to address challenges collectively and ensures a shared commitment to project success.
How did Navitas Life Sciences’ expertise in risk management contribute to the success of the clinical trial?
Navitas Life Sciences played a pivotal role in ensuring the success of the Biosimilar study through exceptional expertise in risk management. By identifying and mitigating risks early on, we not only safeguarded the integrity of the trial but also contributed to the overall efficiency and success of the project. This dedication to comprehensive risk management underscores Navitas Life Sciences' commitment to delivering high-quality outcomes while navigating the complexities inherent in clinical trial execution.
How did Navitas Life Sciences contribute to the success of the project through their skills in data cleaning, data management, and data analysis?
We have exceptional skills in clinical data management, statistical programming, and the generation of Tables, Listings, and Figures (TLF). Holistic approach to data handling, encompassing data cleaning, management, analysis, and TLF generation, showcased their commitment to delivering comprehensive and high-quality outcomes. Beginning with data cleaning, we implemented rigorous processes to ensure the integrity of our dataset.
Expertise in statistical programming enabled the creation of insightful Tables, Listings, and Figures that provided a comprehensive overview of the trial data. Our integrated approach ensured that the data was not only accurate and reliable but also presented in a format that facilitated meaningful interpretation and decision-making.
ISCR’s 17th Annual Conference
Transformations in Clinical Research for Better Patient Outcomes
Date: 02-03 February, 2024
Venue: Hotel Novotel, HICC, Hyderabad, India
Meet our Experts:
Thirumalaivasan K
Assistant Vice President - CDO
Vikas Nema
Associate Director - CDO
Nidhi Acharya
Senior Manager - Business Development
As pioneers in Biosimilar Clinical Trials, we're breaking barriers and setting new standards, which include risk mitigation, extends to the characterization of biosimilars and discussions within the biosimilars forum. Join us as we highlight the vital role of Biosimilar CROs in shaping the future of pharmaceutical research jobs, and explore the diverse opportunities in the realm of clinical research associates (CRA) jobs.
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