29 Jan 21 | EU | The CHMP recommended 13 medicines for approval. Among the recommendations were two bevacizumab biosimilars, Mabxience’s Alymsys® and STADA’s Oyavas®.
01 Feb 21 | CA | Celltrion announced it has received a notice of compliance from Health Canada for Remsima® SC (subcutaneous infliximab). Remsima® has been approved for the treatment of rheumatoid arthritis.
01 Feb 21 | US & CA | Coherus Biosciences announced it has reached an agreement with Junshi Biosciences for the development and commercialisation of toripalimab (anti-PD-1 antibody) in the United States and Canada. Toripalimab has received breakthrough therapy designation by the FDA for nasopharyngeal carcinoma and the first BLA is expected to be filed later this year.
04 Feb 21 | IN | Enzene Biosciences announced it has received marketing authorisation for its biosimilar teriparatide in India.
04 Feb 21 | In an interview with the Centre for Biosimilars the head of Celltrion’s Medical and Marketing Division, HoUng Kim PhD, discussed its high concentration, citrate-free adalimumab biosimilar. Kim announced that Celltrion has completed patent settlements in the US and is approaching settlements in Europe. Kim also revealed that the application for Celltrion’s US biosimilar adalimumab product was filed in November 2020.