At Similis Bio we believe reference data should be universally accessible and to this end we have developed an information distribution model that creates robust and comprehensive data sets for reference products. This enables you to rapidly implement quality-by-design principles for your biosimilar target, building on reference product analytical data. We offer ready-to initiate non-clinical study designs to maximize the value of our analytical packages.
We start every program with detailed patent discovery work using leading firms to identify composition of matter, analytical, formulation, and process patents present globally that may delay biosimilar approval. Our discovery work evaluates both the innovator company patents and biosimilar competitors.
We then leverage our deep CMC expertise to develop a product that circumvent key patents, limiting exposure of our partners to future litigation and delayed commercial launch.
We begin our reference product analysis up to 10 years before projected biosimilar entry and continue beyond patent expiry, resulting in discrete data sets that you can leverage at any point during the commercialization process.
By purchasing multiple lots over extended periods, we develop methods, identify quality target product profiles with well-defined ranges, and examine critical quality attributes far quicker than possible with standard development workflows.
At Similis Bio we expand on our robust reference product data sets by developing high quality biosimilar assets for licensing by clinical and commercial partners. By strategically prioritizing our portfolio and initiating asset development up to 10 years prior to loss of exclusivity, our partners can delay their decision to pursue a program enabling additional market and competitive analysis prior to commitment. We rely on industry leading cell lines and validate our manufacturing processes with robust analytical tools, significantly de-risking the decision to move an asset towards commercialization.