In comparison to developing generics for small molecule drugs, the development of a biosimilar is far more complex, time consuming and expensive.
Biosimilars are not required to complete the same number of clinical trials as the reference product, however they are subject to more rigorous analytical and clinical development requirements than small molecule generics.
Unlike small molecule generics, biologics have inherent product variations that result from the manufacturing process and complexity of the molecules. Slight differences exist across different manufactured batches of all biologic products, and as a result, biosimilars are defined as being “highly similar and demonstrate no clinically meaningful differences to the products they reference”.[6]
The Biosimilar Process
1. Reference Product Determination
We employ a proprietary standardised process to ensure the right reference sequence is used from the outset of biosimilar development. This includes peptide mass fingerprinting, sequence database and patent searches, intact mass analysis, and X-ray crystallography technology.
3. Biosimilarity Analysis
Our Biosimilarity by Design™ approach, based on QbD principles, tests and confirms biosimilarity at every stage of development, using world-leading internal and independent external analytics capabilities.
5. Regulatory
NeuClone’s Right from the Start® approach to biosimilar product development finds its foundations in the regulations that govern product quality, non-clinical and clinical, biosimilar product development. NeuClone biosimilar product development programs are shaped through direct, and phase appropriate, engagements with the US FDA, the EU EMA and the Australian TGA.
2. Cell Line Development
We develop and screen a multitude of clones through our proprietary high through-put screening (HTS) technology. This ensures only the best producing clones, expressing the right biosimilar, are used.
4. Clinical Comparability
We conduct clinical trials in collaboration with world-leading CROs and take consultation from regulatory bodies, to allow for the most streamlined pathway towards global biosimilar approval.
6. Manufacture
Our biosimilar clone and development scale manufacturing capabilities produce ready-to-transfer manufacturing and analytical packages. The information packages provide robust foundations for scaled-up manufacturing to fulfill clinical/commercial requirements.
