Significant biosimilar activities this week include:
27 Jul 20, EU: Celltrionannounced the European Commission has granted marketing authorisation for Remsima® (biosimilar infliximab) subcutaneous formulation for the treatment of adult patients with ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriatic arthritis and psoriasis.
27 Jul 20: the Centre for Biosimilars reported a study presented at the American Academy of Dermatology's Virtual Meeting Experience 2020 which demonstrated the safety, efficacy and immunogenicity of Boehringer Ingelheim's Cyltezo® (biosimilar adalimumab) is comparable to AbbVie's Humira®.
28 Jul 20: Pfizer released its Q2 FY20 financial results. Pfizer reported a 16% decrease in international revenues for Enbrel® (etanercept), attributing this decrease to biosimilar competition in Europe, Japan and Brazil. Pfizer also revealed that it plans to launch Nyvepria® (biosimilar pegfilgrastim) in the US later this year.
8 Jul 20: Amgen released its Q2 FY20 financial results. Amgen reported the following impact to biologics/biosimilars global sales:
6% year-over-year decrease for Prolia® (denosumab)
9% year-over-year decrease for Enbrel® (etanercept)
28% quarter-over-quarter decrease for Amgevita® (biosimilar adalimumab)
28% year-over-year decrease for Neulasta (pegfilgrastim)
35% year-over-year decrease for Neupogen® (filgrastim)
28% year-over-year decrease for Epogen® (epoetin alfa)
11% decrease year-over-year for Aranesp® (darbepoetin alfa) These decreases were attributed to a range of factors including competition, COVID-19 impacts and lower net selling prices.
29 Jul 20, EU: Shanghai Henlius Biotech and Accord Healthcarejointly announced the European Commission has approved Zercepac® (biosimilar trastuzumab) for the treatment of HER2-positive early breast cancer, HER2-positive metastatic breast cancer and HER2-positive metastatic gastric cancer.
30 Jul 20, IN: Cadila Pharmaceuticalsannounced it has launched Ritucad® (biosimilar rituximab). Ritucad® has been approved for Non-Hodgkin's Lymphoma and rheumatoid arthritis. This follows Cadila's launch of Bevaro® (biosimilar bevacizumab) in India last week.
30 Jul 20, US: Janssenannounced the FDA approved an additional indication for Stelara® (ustekinumab) for paediatric patients with skin lesions or moderate to severe plaque psoriasis.