Pharma Sector Update : Pharmaceuticals Pharma Weekly - ICYMI by Emkay Global Financial Services Ltd
This is the twenty-second edition (week ending 23-Aug-26) of our Pharma Weekly - In Case You Missed It. Key developments in the past week:
1) Sandoz has entered a development, manufacturing, and commercialization agreement with Shanghai Henlius, covering up to 10 biosimilars. The deal is worth up to ~$320mn, and initially covers proposed biosimilars of Erbitux (Cetuximab), Repatha (Evolocumab), and Benlysta (Belimumab).
2) Alvotech highlighted progress across its key biosimilar programs, with Aflibercept already launched in Japan and expected to enter the US market in 4QCY26, subject to approval (relevant for Biocon). Its Keytruda biosimilar, codeveloped with Dr Reddy’s, is advancing through a PK similarity study, while the Prolia/Xgeva (Denosumab) biosimilar was resubmitted to the FDA in Jun26 and is under a standard six-month review (relevant for Dr Reddy’s).
3) MSN has announced the first generic launch of the Teduglutide (Gattex/Revestive) injection across several key European markets (read through for Cipla; MSN has a US DMF but has not filed a Para IV yet).
4) Formycon’s Stelara biosimilar is seeing weaker-than-expected commercial momentum, driven by a highly price-sensitive and challenging market environment. The company said that US market dynamics are improving gradually, while the European autoinjector approval should support its positioning; CY26 revenue guidance for Stelara remains dependent on stronger market penetration (relevant for Biocon).
5) Richter Gedeon’s European launch of the Usymro (Ustekinumab/Stelara) biosimilar has stalled due to manufacturing compliance problems at its partner, Bio-Thera Solutions (relevant for Biocon).
6) Novartis announced that the FDA has updated the Leqvio (Inclisiran) label to recognize that lowering low-density lipoprotein cholesterol (LDL-C) reduces the risk of major adverse cardiovascular events (MACE) in adults at increased cardiovascular risk. Novartis continues to advance its clinical trial program, with >60,000 patients enrolled, and expects readout for two trials evaluating secondary outcomes in CY27 (relevant for Anthem).
7) Eli Lilly’s once-weekly insulin Onswik (experimental basal insulin) received a positive recommendation for National Health Service (NHS) coverage in the UK, potentially allowing eligible type 2 diabetes patients to reduce their injection frequency by 85% versus daily insulin (relevant for Biocon).
8) Lundbeck highlighted strong progress on Bexicaserin for developmental and epileptic encephalopathies. The Phase 3 trial completed randomization in Jul26, with headline results expected in 4QCY26, while the Phase 3 trial for Dravet syndrome is on track to complete randomization in 3QCY26. Positive results could support an NDA submission in CY27 (relevant for Neuland).
9) Dicot Pharma has submitted an EU Clinical Trial Application (CTA) for the Phase 2b study of LIB-01, its investigational erectile dysfunction therapy, planned across the US and Europe. The adaptive study will enroll at least 200 patients to assess repeated dosing and support dose selection for Phase 3, with the EU regulatory decision expected in 4QCY26 (read through for Anthem).
10) Novo Nordisk has sued Viatris over the company’s proposed generic 9-mg tablet (oral Wegovy), asserting formulation and dosing patents, including a formulation patent that expires in CY39 (vs street expectation of a potential generic launch in CY34). Meanwhile, Novo Nordisk has initiated a Phase 3 trial to evaluate lower maintenance doses of its oral Wegovy to establish greater dosing flexibility.
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