Biosimilars

Biosimilars

Unlike a traditional, stand-alone biologic, the development of a biosimilar product presents a distinctly different set of nonclinical, clinical and regulatory expectations as well as substantial scientific and manufacturing challenges. The goal of the biosimilar application is to provide a comprehensive demonstration of biosimilarity in addition to overall safety and efficacy of the product.

Our mission is to provide counsel and critical insights into FDA thinking throughout the biosimilar product development lifecycle, from concept to clinical trials to commercialization. At every stage of the process, you’ll have the confidence of knowing that an industry thought leader in the development and production of biosimilar products is at your side, providing the focused guidance and counsel necessary to position your new product for success.


Our team brings decades of experience at every stage of the biologic regulatory and product development process, from nonclinical testing and verification through manufacturing, design and evaluation of clinical trials to commercialization. This includes expertise in each of the following elements of the product development process: pharmacology/toxicology, quality management, product manufacturing, clinical trial design and evaluation, statistics, GMP, GLP and GCP regulatory compliance.

Every Step of the Way: Biologics Consulting’s Biosimilar Expertise

1
Our consultants will collaborate with your team to assess your biosimilar development plan, define all applicable scientific and regulatory requirements, and craft a customized product development strategy that minimizes cost and time to clinical trials, regulatory approval and commercialization.

2
At the core of any successful biosimilar application (i.e. a 351(k) BLA) is a demonstration of comparability with a reference product. This starts with a comprehensive structural and functional characterization of the proposed product. Our team of world-renowned scientists and former FDA reviewers bring an insider perspective into the latest in Agency thinking – allowing your team to focus on gathering and presenting the scientific data regulators want to see. Our team can assist your team in every aspect of the characterization and analysis process, from understanding the molecule and its function to assessing variability and quality between your proposed product and a reference biologic.

For a successful biosimilar, one must be able to demonstrate comprehensive analytical similarity, from molecular structure and stability through receptor binding and functional activities. Our team can help to design, monitor, interpret and audit the analytical testing process, ensuring that your development plan remains on-track and scientifically valid. Our expertise allows us to recommend strategies that minimize a product’s time to market and maximize the breadth of patient access.

3
Following a successful demonstration of structural and functional similarity, it is necessary to demonstrate the safety and equivalent efficacy of the proposed biosimilar in a nonclinical setting through the use of animal toxicity studies, PK/PD studies and other testing as necessary. Our Pharm/Tox team brings an unparalleled level of expertise to this phase of the biosimilar development process, helping your team to address any residual uncertainties which may be generated during Phase 1 and Phase 2 clinical studies. As former FDA officials and industry leaders, we understand what FDA’s Pharm/Tox reviewers will be expecting from a successful application and we can provide guidance on which approaches, studies and tests will best alleviate the Agency’s concerns while minimizing development costs and time to market. We pride ourselves on understanding the factors involved in the FDA decision-making process at every stage of the development process and leverage that expertise to position our clients for successful outcomes.

4
Biologics Consulting employs a team of clinical experts with regulatory, clinical trial, and clinical operations experience in designing, planning, monitoring, interpreting, and auditing clinical trials for bioequivalence. Our experts will help you design and manage a clinical trial program that demonstrates safety, PK/PD, immunogenicity, and efficacy similarity between your product and its reference.

In addition to assisting clients through the design and implementation of their clinical trial, Biologics Consulting also provides assistance in properly framing the data gathered and developing justifications for any results that deviate from accepted inferiority and superiority margins.

5
One of the goals of any biosimilar product development plan is to receive approval for the greatest number of possible conditions with the minimum amount of testing and trials, while ensuring product safety, efficacy and stability. Throughout your product development process, we focus on helping to design processes that gather the molecular, nonclinical and clinical data necessary to justify extrapolation to other clinical indications, thereby maximizing your market opportunity while lowering development costs.