Significant biosimilar activities this week include:
30 Sep 22 | EU | EMA accepts Biogen tocilizumab MAA
Biogen announced that the EMA has accepted the MAA for BIIB800 (biosimilar tocilizumab). Biogen holds the rights to commercialise Bio-Thera’s product in all countries excluding China under an April 2021 agreement.
28 Sep 22 | Samsung Bioepis to report on Ph III trials of aflibercept biosimilar
Korea Biomedical Review reported that Samsung Bioepis will present on three scientific abstracts on its ophthalmology biosimilars, aflibercept and ranibizumab, at the American Academy of Ophthalmology 2022 between 30 September – 03 October. Samsung Bioepis reported that interim analysis of SB15 (biosimilar aflibercept) indicated an equivalence in efficacy of SB15 and Eylea® in terms of best-corrected visual acuity at 8 weeks in patients with neovascular age-related macular degeneration. This is the first time that Samsung Bioepis has disclosed data on its aflibercept biosimilar.
28 Sep 22 | US | FDA approves Vegzelma™ (biosimilar bevacizumab)
Celltrion announced that the FDA has approved Vegzelma™ (biosimilar bevacizumab) for the treatment of metastatic colorectal cancer; recurrent or metastatic non-squamous non-small cell lung cancer (nsNSCLC); recurrent glioblastoma; metastatic renal cell carcinoma; persistent, recurrent, or metastatic cervical cancer; and epithelial ovarian, fallopian tube, or primary peritoneal cancer.
28 Sep 22 | Intas’ Razumab (biosimilar ranibizumab) achieves similar results in polypoidal choroidal vasculopathy
A new study reported that Intas Pharmaceuticals’ Razumab® (biosimilar ranibizumab) achieved comparable visual acuity outcomes to Lucentis® in patients with polypoidal choroidal vasculopathy.
27 Sep 22 | JP | Celltrion receives approval for Vegzelma™ in Japan
Pulse News reported that Celltrion has received approval for Vegzelma™ (biosimilar bevacizumab) in Japan for the treatment of a number of indications including colorectal cancer, non-small cell lung cancer and metastatic breast cancer.
27 Sep 22 | JP | Japan’s Ministry of Health Approves Keytruda® (pembrolizumab) in four additional indications
Merck announced that Japan’s Ministry of Health has granted approval of Keytruda (pembrolizumab) for four new indications: in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment, for patients with hormone receptor-negative and human epidermal growth factor receptor 2 (HER2)-negative breast cancer; as monotherapy for the adjuvant treatment of certain patients with renal cell carcinoma (RCC); in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with advanced or recurrent cervical cancer; and as monotherapy for the adjuvant treatment of patients with stage IIB or IIC melanoma after complete resection. With these new approvals, Keytruda is now approved for 23 uses in 13 different types of cancer in Japan.
27 Sep 22 | UK | BioNTech and Pfizer seek to invalidate two EU COVID patents
BioNTech and Pfizer have filed suit in the Patents Court of England and Wales seeking to invalidate two Moderna patents relating to COVID vaccine technology. Moderna sued Pfizer and BioNTech for patent infringement in the US District Court for the District of Massachusetts and the Regional Court of Dusseldorf in August 2022.
26 Sep 22 | AU | Reimbursement for Keytruda® (pembrolizumab) expanded
The Australian Department of Health and Aged Care announced that from 1 October 2022 Keytruda (pembrolizumab) will be included in the Australian Pharmaceutical Benefits Scheme (PBS) for the treatment of squamous cell carcinoma of the head and neck. The Health Minister reported that without subsidy patients can pay more than AUD $135,000 per course of treatment, but with the PBS listing, this treatment will cost patients less than AUD $50 per prescription. Keytruda is already PBS-listed for a range of cancers including malignant melanoma, Hodgkin’s lymphoma, non-small cell lung cancer (NSCLC), urothelial cancer, B-cell lymphoma and colorectal cancer.
12 Sep 22 | US | Executive Order for Advancing Biotechnology and Biomanufacturing Innovation
President Biden has made an Executive Order to advance “biotechnology and biomanufacturing innovation for a sustainable, safe, and secure American bioeconomy”, including in relation to “health, climate change, energy, food security, agriculture, supply chain resilience, and national and economic security.” The Order states that it is the policy of the Biden Administration to, amongst other things: “(a) bolster Federal investment in key research and development areas of biotechnology and biomanufacturing; (b) foster a biological data ecosystem that advances biotechnology and biomanufacturing innovation; and (c) improve and expand domestic biomanufacturing production capacity and processes, while also increasing piloting and prototyping efforts to accelerate the translation of basic research results into practice.” The Order provides details of how the policy objectives will be achieved and the timescales involved.
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