Biologics &
Biosimilars

Get the competitive edge for your biological product

We help bring your Biologicals to market quickly and effectively

Navitas Life Sciences has proven expertise in bringing your biologics and biosimilar drugs first to market. Biologics or biological products are drugs that are manufactured from living organisms using complex processes. These drugs must be handled and manufactured with care.  Biologics include therapeutic proteins, cell therapies, monoclonal antibodies, and vaccines.
Lack of affordability and accessibility of biologics is driving markets towards biosimilars. Biosimilars are like biologics in terms of purity, safety and potency but there are certain minor differences in the inactive compounds. Recent research has shown that there will be a significant increase in biosimilar sales in the US, with 25 to 35 new biosimilars expected to hit the market. By 2024, the global biosimilars market is expected to exceed more than US$ 15.0 million.

Experts at handling complexity in biologics and biosimilar studies

Navitas Life Sciences is adept at bringing large molecule biologics to market successfully. Some of the challenges faced during a biologics or biosimilar study are site selection and patient recruitment as the unique requirements of such studies could restrict the patient pool. Other hindering factors include lack of state-of-the-art infrastructure and clinical expertise, and poor coordination with Global Regulatory Authorities. Navitas Life Sciences has developed effective strategies which overcome these challenges.

Proven expertise in Biosimilar and Biologics

Extensive clinical experience and proven trial management

Extensive clinical experience and proven trial management

Ability to design lean protocols for market approval

Ability to design lean protocols for market approval

Effective cost-efficient management of trials

Effective cost-efficient management of trials

Excellent track record for meeting regulatory requirements

Excellent track record for meeting regulatory requirements

Oncology Phase III Biosimilar Study

Rescue of P3 trial from regulatory risk

At Navitas, we understand the complexities of biosimilar studies and deliver results to exceed your expectations

100% on-time completion of key milestones

100% on-time completion of key milestones

Record recruitment completion of patients within timelines

Record recruitment completion of patients within timelines

Good Patient retention with Minimal 10% dropout

Good Patient retention with Minimal 10% dropout

Navitas Life Sciences is your perfect partner for all your biologics and biosimilar study Needs

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Biologics and Biosimilar studies conducted
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Innovative biologics across 200+ sites
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Biosimilars including 3 phase 1- PK/PD across 100+ sites

Building Blocks for successful Biologics and Biosimilar Studies

Biologics and Biosimilars have similar design, but they differ in several ways. We understand the nuances of these two types of drugs, which is why we are pioneers in this field.

Type of Drug
Biologics
Biosimilar
Study
Therapeutic, novel drug development Phase 1- Phase 3 efficacy and safety studies
Pharmacokinetic comparative study Phase 3 efficacy and safety studies
Time to market
8-15 years
7-8 years
Cost
1.2 billion$
100-375 million $
Post authorization studies
Phase IV and pharmacovigilance
Phase IV and pharmacovigilance
Patent
Patentable
Non-Patentable

Gain the Competitive Edge for your Biosimilar Product with Navitas Life Sciences

Inspection ready facilities
Our Bioanalytical labs are CAP and ISO-15189 accredited which are at the forefront of technology and analytical capability. The sites have no competing facilities in the region, leading to exclusive subject access in the specific area.
Ready volunteer access
Healthy volunteers from our 20,000+ database can be rapidly inducted into your study, including people in the geriatric age range. We have state of the art fingerprint-based cross-volunteer participation software to detect patient overlaps with parallel studies.
State of the art technology
Your study set up will be expedited using our tailored multi-analyte methods within 4-5 weeks. You can select from our library of pre-validated assays in 10+ matrices including skin and bone. The entire study will be efficiently optimized using our AI & MI platform, OneClinical..
Advanced data management capabilities

We have FDA 21 CFR Part 11 compliant computer systems for sample and data analyses. Our Quality Management System is ISO 9001 certified. Our data management system includes Computer system validation.

Multidisciplinary capabilities
We have access to specialty hospitals with patients in oncology, psychiatry, dermatology, diabetes and renal impaired patients..

Leveraging the Efficiency of AI &ML in Building Efficient Studies

All our clinical trials are backed by OneClinical, our AI&ML driven platform that offers you near real time data visibility and analytics in an outcomes-based engagement model. With OneClinical, you can make informed decisions and take proactive action to maximize the success of your clinical trial.

OneClinical Delivers Better Outcomes for You

Save Time

We have the technical expertise to drive standardization and near real time monitoring to lower cycle times

Time for Complex Study Mapping

Cycle Time to Develop Initial Interface for Data Warehouse

Overall Cycle Time

cost to develop initial Interface for data warehouse

field monitoring costs through Triggers, Reduced SDV

cost of clinical monitoring

Reduce Cost

We can drive and deliver significant reduction in total cost through people, process and technology capabilities