Biological medicines are used to treat a wide range of diseases and medical conditions, including serious diseases such as rheumatoid arthritis and psoriasis, and life-threatening diseases such as cancer. Fresenius Kabi has a long-standing heritage in high-quality pharmaceutical development and is now bringing this expertise to the field of biosimilars to help more patients gain access to modern therapeutic options. Fresenius Kabi's focus here is on the areas of autoimmune diseases and oncology.
A biosimilar is a biological product that is highly similar to another approved biological product, known as "reference product." The biosimilar product is equivalent to the reference product in terms of effectiveness and safety.
- Biological medicines are large, complex compounds grown in or derived from natural living cell lines
- Biologic drugs have multiple levels of structure (primary, secondary, tertiary, quaternary) and post-translational modifications
- Due to the variability of the biological system and manufacturing process, biological medicines may show a certain degree of variation, even between batches of the same product
- Although immunogenicity could be a potential concern for all biologics, experience shows that harmful immunogenicity is unlikely to occur after a change to the manufacturing process of a biologic or after switching between highly similar biologics
Biosimilars offer affordable therapies to a large number of patients. As similar versions of biologic drugs already approved, they make state-of-the-art therapies affordable and accessible to a larger and increasing number of patients. Lower costs increase the uptake of high value biologics and lead to improved patient care. Cost savings can be reinvested in the development of new and innovative therapies.
Already, more than one in three new drug approvals is a biopharmaceutical and this global market, including biosimilars, is expected to grow significantly in the coming years and decades.