Significant biosimilar activities this week include:
23 Aug 22 | Amgen announces the results of Ph III eculizumab trials
Amgen announced the results of a Ph III study evaluating the efficacy and safety of ABP959 (proposed eculizumab biosimilar) compared with Soliris® in adult patients with paroxysmal nocturnal haemoglobinuria. Amgen reported that the study met its primary endpoints and that the safety and immunogenicity profile of ABP 959 was comparable to Soliris.
24 Aug 22 | AU | TGA approves Samsung Bioepis’ Byooviz® (biosimilar ranibizumab)
Samsung Bioepis’ Byooviz® (biosimilar ranibizumab) was approved in Australia for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR), visual impairment due to choroidal neovascularisation (CNV) or choroidal neovascularisation (CNV) secondary to pathologic myopia (PM), and visual impairment due to macular oedema secondary to retinal vein occlusion (RVO). Byooviz was developed by Biogen and is being supplied by Samsung Bioepis under a deal inked in 2019.
Samsung Bioepis obtained marketing approval for Byooviz in the US and EU in September 2021, Canada in March 2022, and in Korea in May 2022. It was reported in September 2021 that Samsung Bioepis took a licence for ranibizumab from Genentech from June 2022.
25 Aug 22 | Novartis announced that it will spin off Sandoz
Novartis announced that it will spin off Sandoz into a new publicly traded standalone company. The new company will be headquartered in Switzerland and will be listed on the SIX Swiss Exchange, with an American Depositary Receipt program. Novartis reported that this separation will allow it to build a focused innovative medicines company. Novartis first announced that it would undertake a strategic review of the Sandoz division in October 2021, and in July 2022 confirmed that a decision on Sandoz’s future would be made by the end of 2022.
25 Aug 22 | Alvotech commences confirmatory study for denosumab biosimilar
Alvotech announced that it has commenced a confirmatory patient study for AVT03 (biosimilar to Prolia® and Xgeva®, denosumab). The objective of the study is to demonstrate clinical similarity of AVT03 to Prolia® in terms of efficacy, safety, immunogenicity and pharmacokinetics in postmenopausal women with osteoporosis. The results from this trial will be used to extrapolate to additional Xgeva® indications. Alvotech commenced phase I trials for denosumab in July 2022.
26 Aug 22 | EU | EC approves Formycon’s Ranivisio® (biosimilar ranibizumab)
Formycon announced that the European Commission has approved Ranivisio®, biosimilar to Lucentis®/ranibizumab developed by Bioeq (which is a joint venture between Formycon and Polpharma Biologics). Ranivisio is EC approved for the treatment of neovascular (wet) age-related macular degeneration (nAMD), the treatment of visual impairment due to diabetic macular oedema (DME) or choroidal neovascularization (CNV), the treatment of proliferative diabetic retinopathy (PDR) as well as the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO).
Earlier this month, Coherus announced the US approval of Cimerli™ with interchangeability designation, which Bioeq licensed to Coherus for the US. The Bioeq product was also approved in the UK in May 2017 as Teva’s Ongavia®.
26 Aug 22 | Merck proposed acquisition of Seagen
Merck & Co is reportedly in negotiations to acquire Seagen Inc (previously known as Seattle Genetics, Inc), with negotiations presently having stalled due to a failure to agree on price. The acquisition could give Merck access to Seagen’s pipeline of antibody-drug conjugates (ADCs). Merck has previously announced strategic oncology collaborations with Seagen for two of its ADCs as well as Merck taking a USD1B equity stake in Seagen. Neither Merck nor Seagen have made any formal announcement about the purported acquisition.
26 Aug 2022 | US & DE | Moderna sues Pfizer and BioNTech for patent infringement over COVID vaccine
Moderna has announced that it commenced proceedings against Pfizer and BioNTech in both the U.S. District Court for the District of Massachusetts and the Regional Court of Düsseldorf in Germany last Friday seeking damages for patent infringement relating to the Pfizer/BioNTech COVID vaccine. Interestingly, Moderna is not seeking injunctions.
The lawsuit is reported to be based on three patent families Moderna filed between 2011 and 2016. The Moderna press release says:
“Moderna believes that Pfizer and BioNTech’s COVID-19 vaccine Comirnaty® infringes patents Moderna filed between 2010 and 2016 covering Moderna’s foundational mRNA technology. This groundbreaking technology was critical to the development of Moderna’s own mRNA COVID-19 vaccine, Spikevax®. Pfizer and BioNTech copied this technology, without Moderna’s permission, to make Comirnaty®.”
This lawsuit is despite Moderna’s October 2020 pledge to not to enforce its COVID-19 related patents while the pandemic continued. This pledge was updated in March 2022, when “the collective fight against COVID-19 entered a new phase and vaccine supply was no longer a barrier to access in many parts of the world”. Moderna’s position is now that “while it would never enforce its patents for any COVID-19 vaccine used in the 92 low- and middle-income countries in the GAVI COVAX Advance Market Commitment (AMC 92), Moderna expected companies such as Pfizer and BioNTech to respect its intellectual property rights and would consider a commercially reasonable license should they request one for other markets. Pfizer and BioNTech have failed to do so.”
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