09 Nov 21 | Coherus BioSciences reported its Q3 2021 financial results. Coherus announced that FDA review of CHS-201 (proposed adalimumab biosimilar) is advancing towards the target action date in December 2021. Coherus also disclosed that the FDA has accepted the BLA for its proposed toripalimab biosimilar for advanced nasopharyngeal carcinoma, with a target action date of April 2022.
10 Nov 21 | Celltrion announced its Q3 2021 financial results. Celltrion reported that Remsima® (infliximab biosimilar) has obtained a 53% market share in Europe and 21% market share in Japan. Celltrion reported that Truxima® (rituximab biosimilar) has obtained a 40% market share in Europe and Herzuma® (trastuzumab biosimilar) has obtained a 14% market share in Europe. Celltrion also reported that it expects to launch biosimilar bevacizumab in 2022, biosimilar ustekinumab in 2023, biosimilar omalizumab and aflibercept in 2024 and biosimilar denosumab in 2025.
12 Nov 21 | EU | The CHMP recommended approval of Celltrion’s regdanvimab for the treatment of adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.
12 Nov 21 | RegenXBio announced additional interim data from its Ph II trials of RGX-314 (proposed one-time gene therapy for the treatment of wet age-related macular degeneration, diabetic retinopathy and other chronic retinal diseases). RGX-314 is a recombinant adeno-associated virus (AAV) gene therapy vector carrying a coding sequence for a soluble anti-VEGF protein.
12 Nov 21 | AU | AU’s PBAC published the outcomes from its July 2021 meeting. PBAC recommended listing:
- Pfizer’s Abrilada® (50mg/mL adalimumab biosimilar) in 20mg/0.4mL syringe, 40mg/0.8mL syringe and 40mg/0.8mL pen for all indications as Humira®.
- Janssen’s Darzalex SC® (daratumumab) for all indications for which the intravenous form of daratumumab is currently listed.
- Pfizer’s Enbrel® (etanercept) in 50mg/1mL single use dose-dispenser cartridges under the same conditions as existing listings for etanercept.
- BMS’ Opdivo® (nivolumab) for the treatment of patients with advanced or metastatic oesophageal squamous cell carcinoma who have disease progression following treatment with a fluoropyrimidine and platinum (FP)-based chemotherapy regimen.
Pearce IP offers Australian based, generics and biosimilars focused lawyers, attorneys and regulatory affairs experts, with incomparable global experience, technical competence, and commercial elegance. Call us today on 02 9023 9988 or email info@pearceIP.law.