See the DrugPatentWatch profile for canakinumab
Biosimilars for canakinumab, a monoclonal antibody used to treat auto-inflammatory diseases, may use different raw materials during the manufacturing process. While the specific variations in raw materials can vary between manufacturers, they generally adhere to the same class of materials used in the original biologic drug [1].
The active pharmaceutical ingredient (API) in canakinumab and its biosimilars is a human monoclonal antibody that targets interleukin-1 beta (IL-1β), a cytokine involved in inflammatory processes [1]. The production of these monoclonal antibodies typically involves recombinant DNA technology, where the DNA sequence encoding the antibody is inserted into a host cell, such as Chinese hamster ovary (CHO) cells [1,2].
While the primary raw materials, such as the host cells and the DNA sequence, remain consistent, there can be variations in other raw materials used during the manufacturing process. These may include:
1. Cell culture media: The nutrients and growth factors used to support the growth of host cells can vary between manufacturers [1].
2. Downstream purification materials: The materials used to purify and isolate the monoclonal antibody, such as chromatography resins, may differ between manufacturers [1].
3. Excipients: These are inactive substances that help stabilize and deliver the active ingredient. Excipients can vary between manufacturers, but they must meet regulatory requirements to ensure safety and efficacy [1].
It is important to note that biosimilars must demonstrate similarity to the reference biologic drug in terms of quality, safety, and efficacy [1]. This includes a comprehensive characterization of the drug substance and drug product, as well as non-clinical and clinical studies to demonstrate comparable pharmacokinetics, pharmacodynamics, and clinical efficacy [1].
Sources:
[1] "Biosimilars: Information for Healthcare Professionals." European Medicines Agency, 2021, www.ema.europa.eu/en/documents/leaflet/biosimilars-information-healthcare-professionals_en.pdf.
[2] "Canakinumab." DrugPatentWatch, 2021, drugpatentwatch.com/drugs/canakinumab.