Biosimilars are biological medicines that, as the name suggests, are highly similar to other already approved drugs. They are generally derived from a living organism such as a human, animal, microorganism or yeast and include monoclonal antibodies, blood components, gene therapy, tissues and vaccines.
While therapeutic grade biosimilars are subject to the same quality, safety and efficacy standards that apply to all biological medicines, research grade biosimilars are intended as tools for pre-clinical testing and are widely used as a benchmark for evaluating novel drugs.
Adalimumab, better known as Humira®, is a recombinant human IgG1 monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells. It is used to treat conditions including rheumatoid arthritis, Crohn's disease, ulcerative colitis, psoriasis and ankylosing spondylitis, and functions by specifically binding human tumor necrosis factor α (TNFα) to reduce inflammation. Amgevita, Imraldi, Hyrimoz, Hulio and Idacio are all approved Adalimumab biosimilars.
Atezolizumab, sold under the brand name Tecentriq®, is a humanised IgG1 monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells. It has been approved to treat advanced or metastatic cancers including urothelial carcinoma, non-small cell lung carcinoma, triple-negative breast cancer, hepatocellular carcinoma, and melanoma. Atezolizumab works by binding programmed death-ligand 1 (PD-L1), a protein that is over-expressed by many cancer cells; by preventing PD-L1 binding to PD-1 receptors on the surface of activated T cells, Atezolizumab drives an active immune response that results in cancer cell death.
Bevacizumab, also known as Avastin®, is a humanised IgG1 monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells. It targets vascular endothelial growth factor (VEGF), a signalling protein that promotes angiogenesis (the growth of new blood vessels) and that is over-expressed by some cancer cells. Bevacizumab is approved to treat advanced colon, lung, kidney and brain cancers, and metastatic breast cancer, and has also been used as a therapy for ‘wet’ age-related macular degeneration. Mvasi and Zirabev are approved Bevacizumab biosimilars.
Cetuximab, branded as Erbitux®, is a chimeric mouse/human monoclonal antibody containing the human IgG1 constant region. It is produced in the NS0 murine myeloma cell line and is used to treat metastatic colorectal cancer and squamous cell carcinoma of the head and neck. Cetuximab functions by specifically binding the epidermal growth factor receptor (EGFR) to inhibit downstream pathway signaling and block the proliferation of tumour cells.
Infliximab, better known as Remicade®, is a chimeric mouse/human IgG1 monoclonal antibody produced and secreted from mouse myeloma (SP2/0) cells. It targets tumour necrosis factor α (TNFα) to suppress the inflammatory response and is used to treat conditions including Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, and plaque psoriasis. Inflectra and Remsima are approved Infliximab biosimilars.
Ipilimumab, sold under the brand name Yervoy®, is a human IgG1 monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells. It has been approved to treat advanced melanoma and can also be given in combination with nivolumab to treat patients with advanced kidney cancer. Ipilimumab targets cytotoxic T-lymphocyte-associated protein 4 (CTLA-4, also known as CD152), a negative regulator of T cell activation, allowing T cells to perform targeted tumour cell killing.
Nivolumab, also known as Opdivo®, is a human IgG4 monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells. It targets the programmed cell death-1 (PD-1) receptor expressed on the surface of activated T cells to disrupt its interaction with programmed death-ligand 1 (PD-L1), a protein that is over-expressed by many cancer cells. By blocking PD-1 binding to PD-L1, Nivolumab promotes an active immune response resulting in cancer cell death.
Rituximab, sold under the brand names Rituxan® and MabThera®, is a chimeric mouse/human IgG1 monoclonal antibody produced using Chinese Hamster Ovary (CHO) cells or mouse myeloma-derived cells (either SP2/0 or NS0). It is approved to treat conditions including non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, and rheumatoid arthritis, and functions by targeting the CD20 antigen on B-cells to cause their destruction; this removes malignant B lineage cells that are then gradually replaced. Truxima, Ruxience, and Rixathon are approved Rituximab biosimilars.
Trastuzumab, better known as Herceptin®, is a humanized IgG1 monoclonal antibody produced using Chinese Hamster Ovary (CHO) cells. It targets human epidermal growth factor receptor 2 (HER2), a protein that is over-expressed by some cancer cells, preventing them from receiving growth signals and targeting them for destruction by the immune system. Trastuzumab is used to treat HER-2 positive cancer of the breast, stomach, and oesophagus. Approved Trastuzumab biosimilars include Ogivri, Trazimera, Herzuma, and Ontruzant.