In Vivo Non-Clinical Studies

Biosimilars - An Additional Opportunity for Patients

Non-clinical studies is a critical stage in the drug development. As required by several regulatory agencies, it is essential to demonstrate the biosimilar product matches its innovator products in biological similarities including quality, efficacy and safety before initiating any clinical studies. Creative Biolabs has decates of experience in the recombinant antibody and protein development. Our research grade biosimilar antibody products are provided for your research needs. We also have invested in the development of clinical antibody biosimilars. We have solutions that provide extensive analytical studies to assist in the characterization of biosimilars. To support biosimilar projects, we design an well-designed non-clinical study program in the the animal models. These non-clinical studies should be designed to compare and detect differences if any, between a similar and its reference.

• Pharmacokinetics/Pharmacodynamics (PK/PD) Analysis in Biosimilar Development Programs

Pharmacokinetics (PK) analysis is a quantitative analysis of the kinetics and steady-state relationships of biosimilars. Pharmacodynamics (PD) analysis is a quantitative analysis of the relation of drug concentration at an effect site to biosimilar effect.

Key parameters:

1. Area under the curve (AUC)
2. Clearance
3. Half-life

• Toxicokinetics Analysis in Biosimilar Development Programs

The primary goal of toxicokinetics analysis is to determine the relationship of between the toxicity and a corresponding level of drug exposure, informing dose considerations and drug safety margins. Creative Biolabs has expertise in toxicokinetics analysis and interpretation.

Related assays:

1. Safety pharmacology
2. Reproductive toxicology
3. Mutagenicity and carcinogenicity studies

Models for In Vivo Non-clinical Studies

Non-clinical studies in the relevant animal model are conducted to assess similarity of in vivo activity and toxicokinetics. The common animal models include rodent (rat/mouse) and non-rodent species (dog/cat) or non-human primates. The aim of these studies is to further support comparability or to detect potential differences between the biosimilar and reference products.

Our team of experts carry out a proper plan in vivo non-clinical studies to demonstrate the comparability of biosimilar and reference products. Our expertise and ability supports:

• The establishment of comprehensive comparability studies with the reference medicine
• The establishment of the most relevant and appropriate animal model(s)
• The design of the dosage form, dose, strength and route of administration
• The evaluation and analysis of data
• The understanding of the requirements of the regulatory agencies

Find Out More Stages in Biosimilar Development:

Collaboration

Biosimilars are a huge opportunity. Creative Biolabs is focused on the next generation of biosimilar development and manufacturing. Our unrivaled expertise in the antibody field can maximize the chances of developing a successful biosimilar. We deploy a range of programs that encompass many different analytical techniques ranging from the evaluation of physiochemical properties, biological activity and stability, in vivo non-clinical studies, and similarity evaluation. We are also looking for partnerships to co-develop biosimilars. We are pleased to provide custom services available according to customer demands. Do not hesitate to contact us if you are interested in discussing partnerships with us.

Reference

1. Sewell, F.; et al. Waiving in vivo studies for monoclonal antibody biosimilar development: National and global challenges. 2016, Toxicology Letters 258: S323.

For research use only. Not intended for any clinical use.