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Organon and Samsung Bioepis announced that Hadlima®, biosimilar to AbbVie’s Humira® (adalimumab), is now available in the US.  Hadlima® is available at a list price of $1,038, an 85% discount in comparison to the list price of Humira®.  Samsung Bioepis announced a global se...

Seven biosimilars to AbbVie’s Humira® (adalimumab): Coherus Biosciences’ Yusimry®, Organon and Samsung Bioepis’ Hadlima®, Sandoz’s Hyrimoz®, Celltrion’s Yuflyma®, Fresenius Kabi’s Idacio®, Biocon Biologics’ Hulio® and Boehringer Ingelheim’s Cyltezo® are now comm...

The Korea Biomedical Review reported that Celltrion has filed an NDA with the FDA for CT-P42 (aflibercept), biosimilar to Regeneron’s Eylea®.  Based on its phase III trials which demonstrated equivalence and similarity to Eylea®, Celltrion is seeking approval for all adult ...

Kashiv Biosciences has completed a Phase I study comparing ADL-018, its omalizumab biosimilar, to Xolair® as marketed in the US by Genentech and in Europe by Novartis.  The study was a randomized, double blind, three-arm, single dose, parallel group, PK, PD and safety and i...

The US District Court of Delaware has denied Biogen’s motion for preliminary injunction in its proceedings against Sandoz which were commenced in September 2022 regarding Sandoz’s natalizumab biosimilar.  Biogen and Sandoz filed a joint stipulation and proposed schedule, se...

Express Pharma reported that Enzene Biosciences announced its launch of bevacizumab, biosimilar to Genentech’s Avastin®, in India to treat metastatic colorectal cancer, non-squamous non-small cell lung cancer and glioblastoma.

This news comes after Lupin and Enzene a...

Formycon and Klinge Biopharma announced that its BLA for FYB203 (biosimilar to Regeneron’s Eylea® aflibercept) has been submitted to the FDA. A response from the FDA is expected by the end of August 2023.  FYB203 is being developed by Formycon, and will be commercialised by...

Alvotech provided an update about its high concentration adalimumab (AVT02) application in the US.  Alvotech has announced that the FDA issued a complete response letter (CRL) for its second BLA for AVT02 (high-concentration adalimumab, biosimilar to AbbVie’s Humira®, with ...