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On 6 October 2026, Celltrion announced the US launch of Omlyclo®, biosimilar to Genentech/Novartis’ Xolair® (omalizumab).  Omlyclo® is the first omalizumab biosimilar on the US market and is available in three dosage forms: 75 mg, 150 mg and 300 mg.

Omlyclo® was laun...

On 5 October 2026, Alvotech announced that the FDA has approved its supplement to the Biologics License Application for AVT02 (marketed as Simlandi® in the US), biosimilar to AbbVie’s Humira® (adalimumab). This approval allows drug manufacturing in a second production...

On 1 October 2026, Fresenius SE announced that it has completed its acquisition of Spanish-based mAbxience by acquiring the remaining 45% stake in the company, having taken a 55% majority stake in 2022.  The acquisition was completed for up to €750 million, including a cont...

On 1 October 2026, Celltrion’s Avtozma® (tocilizumab), biosimilar to Genentech’s Actemra®, became the first tocilizumab biosimilar to be listed on Australia’s Schedule of Pharmaceutical Benefits (PBS).  The PBS listing of Avtozma® will result in a mandatory 25% statutory pr...

On 1 October 2026, Samsung Bioepis and Teva Pharmaceuticals announced a global collaboration and licence agreement to expand their existing partnership for up to six additional biosimilars.  The products covered by the agreement include SB44, biosimilar to Novartis’ Ilaris®...

On 30 September 2026, Korea Biomedical Review reported that MSD has launched Keytruda SC™ (pembrolizumab and berahyaluronidase alfa) in Korea and will begin shipping product starting on 1 October 2026.

Keytruda SC™ received approval from Korea’s Ministry of Foo...

On 30 September 2026, the US District Court for the District of Delaware granted Janssen a preliminary injunction preventing Accord Biopharma and Bio-Thera Solutions from launching Immgolis™ and Immgolis Intri™ (BAT2506), biosimilars to Janssen’s Simponi® and Simponi Aria® ...