Biosimilars
Pfizer gains Japanese approval for infliximab biosimilar
Pfizer Japan announced on 2 July 2018 that it had gained Japanese approval for its infliximab biosimilar.
Positive results for infliximab and trastuzumab biosimilars
Celltrion Healthcare (Celltrion) and Samsung Bioepis have both announced positive results for their infliximab and trastuzumab biosimilars, respectively.
US pharmacies sue J&J for stifling infliximab biosimilars
Two major US pharmacy chains, Walgreen and Kroger, have sued healthcare giant Johnson & Johnson (J&J) in the US District Court Eastern District of Pennsylvania. The pharmacies allege that J&J prevented insurers from covering biosimilars of its blockbuster immunology drug Remicade (infliximab).
Biosimilars applications under review by EMA – June 2018
The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or reference drug.
Biosimilarity testing using very low doses of rituximab
Rituximab is a chimeric, monoclonal antibody directed against CD20 expressed on B lymphocytes [1]. Currently approved indications for use are non-Hodgkin lymphomas, chronic lymphatic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic angiitis [2]. However, rituximab is frequently used ‘off label’ for the treatment of numerous antibody-dependent autoimmune diseases [3].
FDA rejects botulinum toxin biosimilar from Evolus
US-based Evolus announced on 16 May 2018 that the US Food and Drug Administration (FDA) had rejected its application for approval of DWP‑450 (prabotulinumtoxinA).
FDA rejects Amgen’s trastuzumab biosimilar
Biotech giant Amgen announced on 4 June 2018 that the US Food and Drug Administration (FDA) had rejected the application for approval of its trastuzumab biosimilar.
Biosimilar insulins have same efficacy and safety as reference biologicals
Researchers from the US have found that biosimilar insulins have comparable safety and clinical efficacy as their reference biologicals [1].
Biosimilar infliximab blocked in Australia
Switzerland-based drug giant F. Hoffmann-La Roche (Roche) has gained a temporary order in an Australian Federal Court blocking Sandoz from launching its rituximab biosimilar.
Savings with use of biosimilar trastuzumab for breast cancer patients in Croatia
Breast cancer is worldwide the most common cancer in women. In 2012 alone, there were approximately 464,000 new cases and 131,000 deaths from breast cancer in Europe. In Croatia, breast cancer was the fourth leading cause of death among women and ninth in both sexes in 2016.
