keyboard_arrow_upThe world’s first (official) biosimilar antibody goes to… Rheumatoid Arthritis
keyboard_arrow_downThe world’s first (official) biosimilar antibody goes to… Rheumatoid Arthritis

  The end of July 2012 proved exciting for the world of biosimilar manufacturers. However, for the regulatory officials worldwide it meant more uncertainty and unknowns about proper, global biosimilar guidelines. On 23 July, South Korean biosimilar manufacturer Celltrion announced the approval of Remsima (CT-P13), a biosimilar antibody, by the Korean Food and Drug Administration. Remsima is a biosimilar version of Johnson & Johnson’s Remicade (infliximab) which was one of the first monoclonal antibody TNF inhibitors approved for the treatment of Rheumatoid Arthritis (RA). Remsima is approved for several indications and will be marketed in Asia and South America by the end of the year.

keyboard_arrow_upFake Avastin reignites ‘track-and-trace’ debate, but the clock is ticking
keyboard_arrow_downFake Avastin reignites ‘track-and-trace’ debate, but the clock is ticking

The US Food and Drug Administration (FDA) announced in February that counterfeit vials of Roche/Genentech’s cancer drug Avastin were sold to a number of medical practices across the country. While the exact sources of the phony drug remain a mystery, authorities traced the fake batch through several distributors throughout Canada, the UK, Denmark and Switzerland to only end up with an unlicensed supplier in the Middle East as the possible culprit.  When tested, the phony batch did not contain any bevacizumab, the active ingredient in Avastin, which was substituted with salt and starch. Along with fake batch numbers, the drug packaging was also counterfeit, bearing Roche’s name and French labelling, contrasted to the authentic Avastin packaging which imprints Genentech’s name and has English labelling.