Author name: development

Successful biosimilar approval is determined by how well biosimilarity can be demonstrated between the proposed product and its innovator product. An analytical biosimilarity study provides the technical data that would confirm the similarity of critical quality attributes (CQAs) of the proposed product to its innovator in terms of safety, efficacy, and potency. This constitutes comprehensive

Regulations surrounding biosimilar development are based on how well the similarity between the proposed molecule and the reference product (RP) can be demonstrated. Indeed, there is a need for increased access to cost-effective treatment for various conditions, which drives biosimilar development. Regulatory agencies such as the US Food and Drug Administration (FDA) and the European

As per FDA’s pre-requisites for Abbreviated New Drug Application (ANDA) filings, applicants should be able to demonstrate their product’s sameness or similarity to its innovator product or Reference Product (RP). All the data generated by applicants on generic versions should be equivalent or the same as that for reference-listed drugs (RLD). The CDER recently issued

The pharmaceutical regulatory landscape in the UK has experienced many changes since Brexit. Several guidelines have been updated for more UK-specific pharmaceutical product regulation. Among these includes the ‘Guidance on the licensing of biosimilar products’ that was first published on the 6th of May 2021 with the aim to outline clear requirements for biosimilar product

The regulatory landscape is consistently evolving as it faces ever-changing guidelines and regulations. On one hand, these patient-centric regulatory changes ensure that safe, efficacious, and high-quality pharmaceutical products reach the market. On the other hand, key stakeholders in the pharmaceutical regulatory environment face significant obstacles. Needless to say, these regulatory challenges are not limited to