Pearce IP BioBlast®: w/e 15 April 2022

by , | Apr 19, 2022

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.

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.

Print Page Mail Article

Get our Pearce IP Blogs & BioBlast® sent directly to your inbox

Subscribe to our Pearce IP Blogs and BioBlast® to receive our updates via email.

Our Latest News