It’s an exciting time for companies joining the Biosimilar race.
As we get more experienced to apply more advanced technologies, as well as new production processes for biologics, the regulatory landscape and recent strategies for the development of Biosimilars are rapidly evolving at the same time. In Biosimilar development, it isn’t easy to keep track of best development practices and regulatory expectations. Additionally, trends can be observed within leading health authority agencies to become more open for discussions and accept new scientific- and product-tailored development strategies to establish and demonstrate Biosimilar comparability. As usual, it´s all about risk assessment, impact evaluation, and scientific-based justifications, but agencies are actively paving the way for Biosimilars with new regulatory procedures and guidelines. In general, biological manufacturing processes show an inherent variation in terms of process and product. It’s important to look at the development of Biosimilars from an integrated standpoint that includes the essential quality, non-clinical and clinical elements. Obviously, there is a high demand for Biosimilar CMC development as it plays a critical role in demonstrating comparability to the reference product.
What is it about
In our latest update, you'll read more about:
- the wave of biosimilars at the horizon
- development challenges and biosimilar comparability
- best practices and orthogonal approaches
- the rapidly evolving landscape
Download the whitepaper and feel free to contact us if you have any questions regarding Biosimilar development