JSR Life Sciences’ Similis Bio announced plans to enter into a partnership with Novel351K to co-develop three undisclosed biosimilar programs. Under the initial agreement, Similis will be responsible for cell line development, analytics, process development, and cGMP production, leading to pharmacokinetics/pharmacodynamic clinical trials, while Novel351K will assist with accelerating the development of the programs to commercialisation.
Alvotech exclusive agreement with Advanz Pharma regarding omalizumab for EU, UK, CA, CH and ANZ
Alvotech announced that it has entered into an exclusive agreement with Advanz Pharma for the commercialisation of AVT23 (omalizumab, biosimilar to Novartis’ Xolair™). The agreement covers the European Economic Area, UK, Switzerland, Canada, Australia and New Zealand. Alvotech will be responsible for development and manufacture, while Advanz Pharma will handle registration and commercialisation of AVT23.
Alvotech and Fuji Pharma add new product to exclusive commercialisation partnership
Alvotech and Fuji Pharma announced an expansion to their existing exclusive commercialisation partnership in Japan, adding a new undisclosed biosimilar candidate. The commercialisation agreement, which was first announced in 2018 and was most recently expanded in February 2022, now covers seven products.
Merck completes tender offer to acquire Imago BioSciences, Inc
Merck announced that it has completed the cash tender offer for all of the outstanding shares of common stock of Imago BioSciences, Inc for $36 per share. Merck intends to complete the acquisition of Imago through a merger of Merck’s wholly owned subsidiary and the common stock of Imago will no longer be traded on the Nasdaq.
Boan Biotech and CP Qingdao deal re Boyoubei® (biosimilar denosumab)
Luye Pharma announced that its subsidiary Boan Biotech has signed an agreement with CP Pharmaceutical Qingdao Co., Ltd. (CP Qingdao) to grant CP Qingdao the right to commercialise Boyoubei® (biosimilar denosumab) in mainland China. Boyoubei was approved by China’s NMPA in November 2022.
Hikma and Celltrion sign agreement for Vegzelma® (biosimilar bevacizumab)
Hikma Pharmaceuticals announced that is has signed an exclusive licensing agreement with Celltrion for Vegzelma® (biosimilar bevacizumab CT-P16) for MENA (Middle East and North Africa) markets. Vegzelma is approved in the US and CA, and is the seventh biosimilar to be licensed by Celltrion to Hikma, following Truxima® (rituximab), Remsima® (intravenous infliximab), Herzuma® (trastuzumab), Remsima® SC (subcutaneous infliximab), Yuflyma™ (adalimumab), and CT-P43 (ustekinumab). The deals regarding CT-P43 (biosimilar ustekinumab) and Yuflyma™ (biosimilar adalimumab) were announced in 2022.
Alteogen and Sandoz sign exclusive licence agreement
Alteogen announced that it has entered into an exclusive licence agreement with Sandoz for the use of ALT-B4 (novel hyaluronidase derived using Alteogen’s Hybrozyme™ technology) to develop a subcutaneous version of an undisclosed Sandoz biosimilar product. The agreement also includes an option for Sandoz to licence the Hybrozyme technology for two further products. Alteogen will receive an upfront payment and is eligible to receive milestone payments and tiered royalties on sales of the commercialised products. Alteogen will be responsible for the regulatory development and commercial supply of ALT-B4 to Sandoz.
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
natalizumab | Tysabri® | Biogen/Elan
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
tocilizumab | Actemra® | Roche
trastuzumab | Herceptin® | Roche/Genentech
BioBlast® Editor and Contributing Author
Naomi Pearce & Sian Hope
Editor: Naomi Pearce, Executive Lawyer, Patent Attorney & Trade Mark Attorney
Contributing Author: Sian Hope, Associate Lawyer
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