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It has been reported that the Munich Regional Court has issued a preliminary injunction against Formycon’s manufacture of FYB202, its Stelara® (ustekinumab) biosimilar, in Germany until expiry of Janssen’s SPC on its basic ustekinumab patent on 20 July 2024.  According to t...

Eli Lilly announced that the FDA has approved its Omvoh® (mirikizumab-mrkz) for the treatment of moderately to severely active ulcerative colitis (UC) in adults.

On 1 April 2023, Eli Lilly launched its insulin glargine (Rezvoglar®) biosimilar to Sanofi’s Lantus®, in ...

Samsung Biologics has announced its Q3/2023 financial results, demonstrating its highest ever quarterly consolidated revenue of ₩1.034T, marking an 18% increase from Q3 2023.  Samsung attributed this revenue hike to an increase in the operating rate of Plant 4 and a sales b...

FDA has approved Samsung Bioepis’ sBLA for Byooviz®, as an interchangeable biosimilar to Genentech’s Lucentis® (ranibiziumab) across all approved indications.  Byooviz® was developed by Biogen and is being supplied by Samsung Bioepis under a deal inked in 2019 covering the ...

Samsung Biologics announced that it has entered a strategic agreement with European VC firm Kurma Partners to develop and manufacture biologics.  Samsung Biologics will provide chemistry, manufacturing, control and development services to Kurma’s companies under the multi-y...

Roche, Genentech, Chugai and Biogen have settled their dispute in the US District Court for the District of Massachusetts regarding Genentech’s Actemra® (tocilizumab) patents.  Roche, Genentech and Chugai instigated proceedings on 23 July 2023, alleging that Biogen’s produc...

Celltrion announced that the FDA has approved its subcutaneous formulation of Zymfentra® (infliximab -dyyb), biosimilar to Janssen’s Remicade®, as maintenance treatment for ulcerative colitis (UC) and Crohn’s disease (CD) following treatment with an IV infliximab.  This is ...

On 1 November 2023, changes introduced following the March 2023 PBAC meeting will take effect with a view to encouraging biosimilar uptake in Australia.  This will simplify the procedure for prescribers for obtaining authority to prescribe (ie an authority script) for certa...

Regeneron and Sanofi announced that that FDA has issued a Complete Response Letter (CRL) regarding the sBLA for Dupixent® (dupilumab) for use in chronic spontaneous urticaria (CSU).  Regeneron and Sanofi said FDA’s CRL requires additional efficacy data to support an approva...