Biosimilars Licensing Agreement Updates

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Earlier this week, Biocon Biologics Ltd. announced that it has entered into a strategic out-licensing agreement with Yoshindo Inc. to commercialize ustekinumab and denosumab biosimilars for the Japanese market.  Pursuant to the agreement, Yoshindo gets exclusive commercialization rights for the biosimilars in Japan, with an estimated market opportunity of $700 million.  In return, Biocon will receive an upfront license fee and milestone payments.  The announcement further states that Biocon’s development of ustekinumab and denosumab include Phase 1 and Phase 3 clinical trials commenced in 2022, and notes that “Biocon Biologics is developing a broad portfolio of 20 biosimilar assets independently or through strategic partnerships.”

Also this week, Alvotech and JAMP Pharma announced that they have expanded their exclusive partnership to commercialize, in Canada, biosimilars developed and manufactured by Alvotech.  The expansion adds the following two biosimilar candidates from Alvotech’s pipeline:  AVT16 (an immunology product) and AVT33 (an oncology product).  As we previously reported, earlier this year JAMP launched SIMLANDI in Canada, a high-concentration, low-volume, citrate-free biosimilar to HUMIRA (adalimumab) developed and manufactured by Alvotech.

Stay tuned to Big Molecule Watch for future biosimilars licensing updates.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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