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BioBlast® w/e 13 Jan 23: Alvotech’s golimumab, Alvotech and Fuji commercialisation partnership, Dong-A ST’s ustekinumab, Coherus and Klinge’s deal for US aflibercept, Boan Biotech and CP Qingdao denosumab deal, Rani and Celltrion’s oral ustekinumab biosimilar

by , | Jan 16, 2023

Significant biosimilar activities this week include:

16 Jan 23 | Dong-A ST publishes the results of Ph III trials of DMB-3115 (biosimilar ustekinumab)

Korea Biomedical Review reported that Dong-A STl has published the results of its global Ph III trials of DMB-3115 (biosimilar ustekinumab).  Dong-A ST reported that the study confirmed the therapeutic equivalence and safety of DMB-3115 compared to Janssen’s Stelara®.  DMB-3115 will be commercialised by Intas Pharma in Japan, Korea and certain countries in Asia under a July 2021 agreement.

13 Jan 23 | JP | 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.

11 Jan 23 | 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.

11 Jan 23 | Alvotech initiates pharmacokinetic study for AVT05 (golimumab biosimilar)

Alvotech announced the initiation of a pharmacokinetic study for AVT05 (biosimilar golimumab candidate to Janssen’s Simponi® and Simponi Aria®).  Alvotech’s portfolio also includes AVT02 (high concentration adalimumab/biosimilar to Humira®) which launched in Canada in April 2022 and Europe in June 2022 and is expected to launch in the US from July 2023; AVT04 (ustekinumab/biosimilar candidate to Stelara®) for which Alvotech recently announced positive topline results; AVT04 (aflibercept/biosimilar candidate to Eylea®) and omalizumab/biosimilar to Xolair®.

10 Jan 23 | CN | 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.

09 Jan 23 | US | Coherus Biosciences and Klinge Biopharma commercialisation agreement- biosimilar aflibercept

Coherus Biosciences announced that it has executed a binding term sheet with Klinge Biopharma granting Coherus the exclusive US commercialisation rights to Klinge’s FYB203 (biosimilar aflibercept, targeting Bayer’s Eylea®, developed by Regeneron).  Coherus expects to complete the transaction in Q1 2023, and to file a BLA later in 2023.  Coherus plans to launch the product at biosimilar market formation, currently expected to be in 2025.

09 Jan 23 | Rani Therapeutics and Celltrion sign agreement for RT-111 (orally administered ustekinumab biosimilar)

Rani Therapeutics announced that it has partnered with Celltrion for the development of RT-111 (orally administered ustekinumab biosimilar).  Under the agreement, Celltrion will exclusively supply drug substance CT-P43 (biosimilar ustekinumab drug substance) to Rani.  Rani is granted an exclusive licence to use CT-P43 in the development and commercialisation of RT-111 and Celltrion has a right of first negotiation to acquire worldwide rights to RT-111 following Ph I trials.  The RaniPill™ capsule, is “intended to replace subcutaneous or intravenous injection of biologics and drugs with oral dosing”.

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