11 Apr 22 | CA | Celltrion announced the launch of Yuflyma® (high-concentration, low-volume, citrate-free and latex-free biosimilar adalimumab) in Canada. Yuflyma® is approved in Canada for ten indications: rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, adult ulcerative colitis, hidradenitis suppurativa, plaque psoriasis, adult uveitis, and paediatric uveitis.
13 Apr 22 | US | Amneal Pharmaceuticals announced that the FDA has approved its BLA for Alymsys® (biosimilar bevacizumab) marking the second of three oncology biosimilar approvals Amneal expects to receive in 2022. Alymsys® was developed by mAbxience, and its approval is the third biosimilar bevacizumab approved in the US.
13 Apr 22 | Korea Biomedical Review reported that Celltrion released the results of its Ph III trials of CT-P16 (biosimilar bevacizumab candidate) at the American Association for Cancer Research 2022. Celltrion said that CT-P16 demonstrated equivalence in efficacy with Avastin®. Based on these results, Celltrion has completed an application for CT-P16 product approval in Korea, the U.S., and the EU seeking approval for a full label.
14 Apr 22 | Cancer Network reported that initial data from AstraZeneca’s Ph II trial of durvalumab and tremelimumab in combination with chemotherapy as neoadjuvant therapy for patients with advanced-stage ovarian cancer was presented at the AACR meeting. The results suggest that more than 80% of all patients had at least had a partial response to treatment, and five patients (11.11%) had a pathologic complete response.
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