Alvotech and Fuji Pharma announced they have agreed on an extension of their exclusive strategic partnership for the commercialisation of four biosimilar medicines in Japan.
US District Court refuses to award costs in pegfilgrastim dispute
US District Court Judge Leonard Stark refuses to grant costs in the Coherus/Amgen (pegfilgrastim) matter. Coherus argued that fees were warranted because Amgen had pursued a baseless claim and appeal, intending to thwart competition.
Shanghai Henlius Biotech reports on Ph III bevacizumab trials
Shanghai Henlius Biotech reports positive results from Ph III trials of its biosimilar bevacizumab candidate.
Prestige BioPharma and Teva Israel exclusive partnership and supply agreement for Prestige’s Tuznue®
Prestige BioPharma and Teva Israel announce they have entered into an exclusive partnership and supply agreement for Prestige’s Tuznue® (trastuzumab biosimilar) in Israel. Under the agreement, Prestige is responsible for registration and commercial supply, and Teva Israel will be responsible for local registration, sales and marketing in Israel.
Biocon Biologics approves capital injection from Goldman Sachs
Biocon Biologics announces it has approved a USD 150 million capital injection from Goldman Sachs. Dr Christiane Hamacher (CEO of Biocon Biologics) announced that this capital injection will enable Biocon Biologics to make prudent investments in R&D, high-quality manufacturing and establishing a global commercial footprint.
Biocon Biologics approves USD 150 million capital injection from Goldman Sachs
Biocon Biologics announced it has approved a USD 150 million capital injection from Goldman Sachs. Dr Christiane Hamacher (CEO of Biocon Biologics) announced that this capital injection will enable Biocon Biologics to make prudent investments in R&D, high-quality manufacturing and establishing a global commercial footprint.
Alvotech enters exclusive partnership with Cipla
Alvotech announces it has entered into an exclusive partnership with Cipla for two oncology biosimilars and three auto-immune biosimilars in South Africa. Under the agreement, Alvotech will be responsible for the development and supply of the products, while Cipla will be responsible for registration and commercialisation.
Alvotech announces exclusive partnership with Cipla for biosimiliars
Alvotech announced it has entered into an exclusive partnership with Cipla for two oncology biosimilars and three auto-immune biosimilars in South Africa. Under the agreement, Alvotech will be responsible for the development and supply of the products, while Cipla will be responsible for registration and commercialisation.
Ocumension Therapeutics reaches a development agreement with Shandong Boan Biological Technology
Ocumension Therapeutics announces it has reached an agreement with Shandong Boan Biological Technology to jointly develop OT-702, a proposed aflibercept biosimilar. Under the agreement, Ocumension has been granted an exclusive license to promote and commercialise the product in mainland China. OT-702 is currently in Ph III trials.
Ocumension Therapeutics announces agreement with Shandong Boan Biological Technology to develop aflibercept
Ocumension Therapeutics announces it has reached an agreement with Shandong Boan Biological Technology to jointly develop OT-702, a proposed aflibercept biosimilar. Under the agreement, Ocumension has been granted an exclusive license to promote and commercialise the product in mainland China. OT-702 is currently in Ph III trials.
SomaLogic signs agreement with FDA for large-scale analysis of proteins
SomaLogic announces it has signed an agreement with the FDA for the large-scale analysis of proteins for the identification of biomarkers that may be useful in demonstrating biosimilarity of a proposed biosimilar and a reference product. It is hoped that the five year collaboration will streamline the development of biosimilars by reducing the need for comparative clinical studies, thus accelerating the delivery of safe, effective and affordable biosimilar treatments.
SomaLogic signs agreement with FDA for identification of biomarkers
SomaLogic announced it has signed an agreement with the FDA for the large-scale analysis of proteins for the identification of biomarkers that may be useful in demonstrating biosimilarity of a proposed biosimilar and a reference product. It is hoped that the five year collaboration will streamline the development of biosimilars by reducing the need for comparative clinical studies, thus accelerating the delivery of safe, effective and affordable biosimilar treatments.
Alvotech Holdings SA completes private placement round
Alvotech announces that its parent company, Alvotech Holdings SA, has successfully completed a $65 million private placement round, which will further finance the development and release of its biosimilar candidates. This $65 million round is part of a larger $100 million round, with a second round expected to close shortly. The new share issue values Alvotech at $1.5 billion.
Alvotech Holdings SA completes $65 million private placement round
Alvotech announced that its parent company, Alvotech Holdings SA, has successfully completed a $65 million private placement round, which will further finance the development and release of its biosimilar candidates. This $65 million round is part of a larger $100 million round, with a second round expected to close shortly. The new share issue values Alvotech at $1.5 billion.
Medicure enters License, Manufacture and Supply Agreement with Reliance Life Sciences
Medicure announced it has entered a License, Manufacture and Supply Agreement with Reliance Life Sciences for a cardiovascular biosimilar product for EU, US and Canada. Medicure is responsible for the regulatory approval process for that product.
Medicure enters License, Manufacture and Supply Agreement with Reliance Life Sciences
Medicure announces it has entered a License, Manufacture and Supply Agreement with Reliance Life Sciences for a cardiovascular biosimilar product for EU, US and Canada. Medicure is responsible for the regulatory approval process for that product.
Alvotech expands strategic partnership with DKSH for biosimilar product commercialisation
Alvotech announces an expansion of its strategic partnership with DKSH to commercialise six new biosimilar product candidates for Asian markets, including Taiwan, Korea, Hong Kong, Philippines, Vietnam, Thailand, Cambodia, Myanmar, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan. These biosimilar candidates’ brand values are estimated around US$1.5 billion in annual sales in the Asia Pacific region, according to IQVIA data.. The biosimilar candidates will address multiple therapeutic areas and represent an estimated (combined) US$1.5 billion in annual sales in the Asia Pacific region.
Alvotech expands strategic partnership with DKSH to commercialise biosimilar candidates in Asia
Alvotech announced an expansion of its strategic partnership with DKSH to commercialise six new biosimilar product candidates for Asian markets, including Taiwan, Korea, Hong Kong, Philippines, Vietnam, Thailand, Cambodia, Myanmar, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan. These biosimilar candidates’ brand values are estimated around US$1.5 billion in annual sales in the Asia Pacific region, according to IQVIA data. The biosimilar candidates will address multiple therapeutic areas and represent an estimated (combined) US$1.5 billion in annual sales in the Asia Pacific region.
Intract Pharma and Celltrion sign development agreement
Intract Pharma and Celltrion announce an agreement to jointly develop the world’s first oral antibody therapeutic for the treatment of IBD. The infliximab product has been cleared by the UK’s MHRA to proceed to Ph 1b/2a clinical trials in patients with IBD during the second half of 2021.
Alvotech and Teva strategic collaboration partnership for biosimilar products
Alvotech and Teva announce a strategic partnership to collaborate on five biosimilar product candidates in the US market. Under the agreement, Alvotech will be responsible for the development, registration and supply of the biosimilars, while Teva will be exclusively commercialising the products in the US. The agreement includes an upfront payment, with subsequent milestone payments, with Alvotech and Teva to share the profits from commercialisation.
VentureTECH, Duopharma and PanGen Biotech announce development joint venture
VentureTECH, Duopharma and PanGen Biotech announce a joint venture to develop a Malaysian biosimilar production facility.
Bio-Thera Solutions enters BAT2506 licensing agreement with Pharmapark
Bio-Thera Solutions annnounces a licensing agreement with Pharmapark for BAT2506 (biosimilar golimumab candidate). Under the agreement, Pharmapark will have exclusive rights to distribute and market the drug in Russia and other CIS countries.
VentureTECH, Duopharma and PanGen Biotech enter joint venture
VentureTECH, Duopharma and PanGen Biotech announced a joint venture to develop a Malaysian biosimilar production facility.
AbbVie and Sosei Heptares deal to discover and develop immunology drugs
AbbVie and Sosei Heptares announce a $409M deal to discover and develop new immunology drugs. The agreement covers the drug-discovery, development and commercialisation of small-molecule medicines that target autoimmune and inflammatory diseases using the G protein-coupled receptor. AbbVie will pay Sosei Heptares up to $32M upfront and at milestones for an additional $377M, along with royalties.
Product specific reports based on extracts from our BioBlast® database
aflibercept | Eylea® | Regeneron
bevacizumab | Avastin® | Roche/Genentech
cetuximab | Erbitux® | BMS/Merck
darbepoetin | Aranesp® | Amgen
denosumab | Prolia®/Xgeva® | Amgen
dupilumab | Dupixent® | Sanofi-Aventis
eculizumab | Soliris® | Alexion
filgrastim (GCSF) | Neupogen® | Amgen
golimumab | Simponi® | Janssen
guselkumab | Tremfya® | Janssen
infliximab | Remicade® | Johnson & Johnson
ixekizumab | Taltz® | Eli Lilly
lecanemab | Leqembi® | Eisai/Biogen
liraglutide | Victoza® /Saxenda® | Novo Nordisk
natalizumab | Tysabri® | Biogen/Elan
olaparib | Lynparza® | AstraZeneca/Merck
omalizumab | Xolair® | Genentech / Novartis
pegfilgrastim | Neulasta® | Amgen
pembrolizumab | Keytruda® | Merck
ranibizumab | Lucentis® | Genentech
regdanvimab | Regkirona® | Celltrion
risankizumab | Skyrizi® | AbbVie
rituximab | Rituxan®/MabThera® | Genentech/Biogen
secukinumab | Cosentyx® | Novartis
semaglutide | Wegovy®/Ozempic® | Novo Nordisk
tocilizumab | Actemra® | Roche
trastuzumab | Herceptin® | Roche/Genentech
ustekinumab | Stelara® | Johnson & Johnson/Janssen
BioBlast® Editor and Contributing Author
Naomi Pearce & Emily Bristow
Editor: Naomi Pearce, Executive Lawyer, Patent Attorney & Trade Mark Attorney
Contributing Author: Emily Bristow, Law Graduate
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