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This is the twenty-sixth edition (week ending 20-Sep-26) of our Pharma Weekly – In Case You Missed It. Key developments in the past week:

1) BMS and Ono Pharma have sued Amgen, alleging that its proposed Opdivo (Nivolumab) biosimilar infringes seven patents. Amgen has submitted the first Opdivo biosimilar application to the FDA, with a decision expected by year-end, while BMS estimates the earliest US entry of Opdivo biosimilars in CY28 (relevant for Biocon).

2) Amneal received FDA approval and has announced the immediate launch of Lanreotide injection (120mg/0.5mL), with Competitive Generic Therapy (CGT) designation. The company has stated that it has large-scale in-house manufacturing capabilities for the product (relevant for Cipla).

3) Sandoz has received Health Canada’s marketing authorization for generic Semaglutide (read through for Dr Reddy’s).

4) The USFDA has accepted for review Organon’s sNDA for Miudella, seeking to extend its duration of use from 3 to up to 6 years for the prevention of pregnancy, with PDUFA action expected in 2QCY27. Organon completed the exclusive global licensing of Miudella in Jun-26, with commercial availability anticipated in late-CY26.

5) Knight Therapeutics’s New Drug Submission for Gemtesa (Vibegron) has been accepted for review by Health Canada for treating overactive bladder in adults. Knight has an exclusive supply and distribution agreement with Sumitomo Pharma for Gemtesa in Canada (relevant for Piramal Pharma).

6) AstraZeneca and Daiichi Sankyo’s Enhertu has received a positive CHMP opinion in the EU for adjuvant treatment of resected HER2-positive breast cancer with residual invasive disease. Separately, the National Institute for Health and Care Excellence has recommended Enhertu for routine National Health Service use in England in HER2-low advanced or metastatic breast cancer (relevant for Cohance).

7) Gilead’s Trodelvy + Keytruda failed both dual primary endpoints in the Phase 3 trial in first-line, PD-L1-high NSCLC, with progression-free survival improving but not reaching statistical significance, while median overall survival was lower vs Keytruda alone (relevant for Cohance).

8) Lundbeck announced that the last patient has been randomized in the global Phase 3 trial evaluating Bexicaserin in children and adults with Dravet syndrome. The trial enrolled over 100 participants aged 2-65 years (relevant for Neuland).

9) Eli Lilly said Foundayo has captured over 30% of new US patients starting oral obesity treatments, narrowing Novo’s early lead with the Wegovy pill (relevant for Divi’s). Lilly also said 60-70% of participants in the US Medicare obesity drug pilot are new to weight-loss treatments, while noting that generic GLP-1 launches in India and Canada have expanded the overall market and absolute volumes for Mounjaro continue to grow.

10) Hikma launched Semaglutide in Saudi Arabia as the first generic version of Ozempic available in the country. The product was developed by OneSource, which received approval earlier this year, with Hikma as its exclusive commercialization partner across MENA.

11) EU lawmakers have backed allowing biosimilar manufacturers to build inventory during the Supplementary Protection Certificate (SPC) period for launch immediately after the expiry of SPC vs earlier allowing manufacture and stockpiling only during the final six months of an originator’s SPC term.

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