Read our latest updates & insights

The Korean Biomedical Review reported that Celltrion has launched Vegzelma®,  biosimilar to Genentech’s Avastin® (bevacizumab), in the US .

Celltrion received FDA approval for Vegzelma® in September 2022 for the treatment of six types of cancer.

The District Court of West Virginia denied Mylan’s emergency motion seeking orders which would require Regeneron to immediately narrow the scope of its infringement proceedings to 12 claims of 3 patents. As it currently stands, Regeneron is required to narrow the scope of t...

Alvotech announced that it received (in March) and responded to (in April) a complete response letter from the FDA regarding its BLA for high concentration (buffer free) formulation of AVT02, biosimilar to AbbVie’s Humira®, and is awaiting the FDA’s assessment of its respon...

Samsung filed a notice of opposition to the grant of Janssen’s Australian patent application AU2019346134 for the treatment of ulcerative colitis using an anti-IL12/IL23 antibody including Stelara® (ustekinumab).  Samsung’s Statement of Grounds and Particulars in support of...

The FDA has scheduled a meeting of its Peripheral and Central Nervous System Drugs Advisory Committee Meeting on 9 June 2023 to discuss full approval of Eisai Co and Biogen’s LEQEMBI™ (lecanemab) for the treatment of Alzheimer’s.

On 5 March 2023, Biogen and Eisai Co ...

The Scottish Medicines Consortium (SMC) accepted Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan) for restricted use within NHSScotland as a monotherapy for the treatment of unresectable or metastatic HER2 positive breast cancer when patients have received one or more pri...

The Korea Herald has reported that Celltrion has confirmed in a phase III study the safety and efficacy of CT-P39, a biosimilar to Genentech/Novartis’ Xolair® to treat asthma and urticaria.  The results indicate that CT-P39 prompted the same biological response in terms of ...

A study published in Clinical Ophthalmology has found that Intas’ Razumab® (ranibizumab) biosimilar to Genentech’s Lucentis® has similar efficacy and safety in Indian patients over 50 years old for treating neovascular age-related macular degeneration (nAMD).  The study pro...