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Celebrating a Decade of Biosimilars Development

Biosimilars are not an exact copy but are similar to the originally approved biological product. Following an abbreviated pathway, they demonstrate equivalent PK, toxicity, similarity, and no clinical change compared to the innovator. The goal of a biosimilar is to introduce lower cost alternatives that can help improve patient access to biological treatments.

Celerion is the premier CRO for PK/PD assessments in healthy subjects and small patient groups. Building upon our bioequivalence and bioavailability expertise, we can design appropriate comparative studies to establish biosimilarity with marketed reference drugs that rely on pharmacodynamic biomarkers and potentially avoid larger patient studies.

With a legacy of over 50 years in clinical research, this year marks a decade of translating science to medicine as Celerion.  To commemorate our 10-year anniversary, we are highlighting 10 years of Biosimilars experience.

Our Top 10 lists of Biosimilars Turn-Key Programs and Bioanalytical Assays:

    1. Adalimumab: Monoclonal antibody that targets and inhibits tumor necrosis factor α (TNFα) activity. Adalimumab is indicated for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriasis, hidradenitis suppurativa, uveitis, and juvenile idiopathic arthritis. Marketed as Humira, the US patent expired in 2016.
    2. Bevacrizumab: Monoclonal antibody that inhibits vascular endothelial growth factor A (VEGF-A). Bevacrizumab is indicated for colon cancer, lung cancer, glioblastoma, and renal-cell carcinoma and age-related macular degeneration.  Marketed as Avastin, the patents expired in the US in 2019 and in Europe in January 2022.
    3. Teriparatide:  A recombinant 34 amino acid portion of human parathyroid hormone (PTH), indicated for osteoporosis. Originating product, Forteo/Forsteo patent expired in 2019.
    4. (Peg)Filgrastrim: Neupogen is the originator filgrastrim product recombinant granulocyte colony-stimulating factor (G-CSF) indicated for conditions of neutropenia. Neulasta is a pegylated form of filgrastrim. Pegylation increases the half-life and stability. Neupogen patent expired in 2006 in Europe and 2013 is the US. Neulasta patent expired in 2015 and 2017 in the US and EU respectively.
    5. Ustekinumab: Marketed as Stelara, it targets IL-12 and IL-23 and is indicated for plaque psoriasis, Chron’s disease and ulcerative colitis. Patents expires in 2023 in the US and in 2024 in Europe.
    6. Omalizumab: Sold under the brand name Xolair, omalizumab is indicated for asthma and chronic idopathic utricaria. By inhibiting immunoglobulin E from binding to high affinity receptors on mast cells and basophils, omalizumab reduces sensitivity to allergens.  Patent expired in 2017 in the US and Europe.
    7. Ranibizumab: Ranibizumab is a monoclonal antibody fragment that inhibits angiogenesis by inhibiting VEGF-A. It treats age-related macular degeneration, a common source of vision loss with aging. It is also effective in diabetic macular edema. The brand name is known as Lucentis and its patent expires in June 2020 in the US and 2022 in Europe.
    8. Cetuximab: A monoclonal antibody that inhibits epidermal growth factor receptor (EGFR) used for the treatment of metastatic colorectal cancer, metastatic non-small cell lung cancer and head and neck cancer. The patent for the brand name product, Erbitux, expired in 2014 in Europe and in 2016 in the US.
    9. Trastuzumab: Monoclonal antibody, sold under the brand name Herceptin. Trastuzumab is a HER2 receptor antagonist, indicated for breast and stomach cancers that are HER2 receptor positive. Patents expired in 2014 in the EU and 2019 in the US.
    10. Etanercept: Commonly known as Enbrel, it is a TNFα inhibitor that functions as decoy receptor for the cytokine. Etanercept is indicated for various rheumatic and psoriatic disorders. US patent is extended to 2028, however the patent is expired in EU and biosimilars are available in this region.

See our full list of biosimilar experience