24 Jun 22 | AU | Samsung Bioepis commences AU revocation action against Fresenius Kabi adalimumab patent
Samsung Bioepis filed a suit against Fresenius Kabi in the AU Federal Court, seeking to revoke AU2020201090 ‘Liquid pharmaceutical composition’ (‘090 patent) which was granted 2 days earlier, on the grounds of novelty, obviousness, lack of utility, lack of best method, lack of clarity and lack of support.
The ‘090 patent is related to Fresenius Kabi’s AU 2015263246 (‘246 patent), which Samsung sought to revoke in 2019. The proceedings were discontinued in early 2020 after Fresenius Kabi surrendered the patent, with Fresenius ordered to pay Samsung’s costs.
The recently granted ‘090 patent, like the earlier granted ‘246 patent, relates to a specific composition of adalimumab, including a histidine buffer, specified sugar and polysorbate.
There is a third granted family member (AU2018222887), which Samsung has not sought to revoke to date, nor has Fresenius asserted it against Samsung.
27 Jun 22 | JP | Daiichi Sankyo submits sNDA in Japan for trastuzumab deruxtecan in HER2 low breast cancer
Daiichi Sankyo announced that it has submitted a sNDA to Japan’s Ministry of Health, Labour and Welfare for trastuzumab deruxtecan for the treatment of adult patients in Japan with HER2 low unresectable or recurrent breast cancer after prior chemotherapy.
29 Jun 22 | US | FDA accepts sBLA for 16 week dosing regimen of Eylea® (aflibercept)
Regeneron announced that the FDA has accepted for review the sBLA for Eylea® (aflibercept) for a 16-week 2mg dosing regimen (after initial monthly doses) in patients with diabetic retinopathy. The FDA has set a target action date of 28 February 2023.
30 Jun 22 | CN | NMPA accepts IND for HLX53 (anti-TIGIT Fc fusion protein)
Shanghai Henlius Biotech announced that the IND for HLX53 (anti-TIGIT Fc fusion protein) has been accepted by China’s NMPA. HLX23 is being developed for the treatment of patients with advanced/metastatic solid tumours or lymphomas.
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.
30 Jun 22 | AryoGen’s denosumab biosimilar has comparable efficacy and safety to Prolia
The results of a phase III study of Iranian biopharmaceutical company AryoGen Pharmed’s denosumab biosimilar Arylia in osteoporosis patients showed that its efficacy and safety were not inferior to Amgen’s Prolia®.
Pearce IP offers Australian based, life sciences 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.