Biosimilars

When the patents for reference medicines expire, medicines that are comparable to the reference products can be manufactured and made available to patients. These are biosimilar medicines.

A biosimilar medicine is a biological medicine which has been shown not to have any clinically meaningful differences from the originator medicine in terms of quality, safety and efficacy.

They can be used to treat the same conditions as the original biological drugs such as cancer and osteoporosis. However, they are generally more affordable, which gives more patients access to these medicines.

Biosimilars require a considerable amount of time and effort for their development as well as the control of the manufacturing process. They also require a significantly bigger amount of data that must be submitted for approval.

Biosimilars are never identical copies of the original reference product. The differences must be kept within strict limits to ensure comparability, resulting in high investments – whether for development, clinical studies, quality assurance in high-tech production processes or approval. The respective competent authority can then confirm that the biosimilar is equivalent to the original product in terms of efficacy, quality and safety.