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Biosimilars Deals 2023

Explore our interactive biosimilar news updates, collating tailored reports by brand, INN, originator/biosimilar applicant, litigation, region, or date. Alternatively, review our weekly BioBlast updates below.

Merck and Daiichi Sankyo Ink US$22B Global Commercialisation Deal for Three Deruxtecan Antibody-Drug Conjugates

Merck and Daiichi Sankyo announced a global development and commercialisation collaboration involving Daiichi’s three deruxtecan antibody-drug conjugate candidates: patritumab deruxtecan, ifinatamab deruxtecan and raludotatug deruxtecan. The companies will jointly develop and commercialise the candidates around the world, except for Japan, where Daiichi retains exclusive commercialisation rights. Daiichi is solely responsible for manufacture and supply.

Merck will pay Daiichi a US$4B upfront payment and US$1.5B in continuation payments over the next 24 months. Contingent on Daiichi meeting future milestones, Merck may make additional payments of up to US$16.5B, reaching a total potential consideration of up to US$22B.

On 18 October 2023, the EC approved AstraZeneca/Daiichi’s (trastuzumab deruxtecan) for a new indication as a monotherapy for the treatment of adult patients with advanced non-small cell lung cancer.

JSR’s Similis Bio and Novel351K announce biosimilars partnership

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.

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.

BioBlast® Editor and Contributing Author

Naomi Pearce & Emily Dwyer

Naomi Pearce & Emily Dwyer

Editor: Naomi Pearce, Executive Lawyer, Patent Attorney & Trade Mark Attorney
Contributing Author: Emily Dwyer, Graduate Lawyer, Trainee Trade Mark Attorney

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