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

1) Roche does not expect biosimilar competition for Perjeta (Pertuzumab) in the US before CY28 or in the EU before CY27 (Organon has the sole biosimilar approval in the US and EU). The company also reported a 9% yoy decline in global Actemra (Tocilizumab) sales in 1HCY26, due to biosimilar competition (Organon is one of the three players in the US Tocilizumab biosimilar market).

2) Almirall reported 10.5% yoy growth in Ilumetri sales to €125mn in 1HCY26 and reaffirmed its >€300mn peak sales guidance. The company also plans to initiate a clinical study to evaluate the 200mg dose in psoriasis in biologic-naive patients, to further strengthen Ilumetri's long-term clinical profile and lifecycle management (relevant for Sun’s Ilumya).

3) Novartis reported 43% yoy cc growth in Kisqali, surpassing $1bn in quarterly sales for the first time, and reaffirmed its $10bn peak sales target. Leqvio grew 59% yoy, driven by strong US demand and a China NRDL rollout (read through for Divis). Vanrafia (Atrasentan) completed EU regulatory filings for IgA nephropathy (relevant for Anthem).

4) NewAmsterdam Pharma and Menarini received a positive EU opinion for Ubeslo (Obicetrapib) and Evlarco (Obicetrapib + Ezetimibe) for primary hypercholesterolemia, with approval expected later this year. Phase 3 studies showed up to 40% LDL-C reduction with Obicetrapib and ~50% with the fixeddose combination (read through for Aarti Pharmalabs, Neuland, and Piramal).

5) Sanofi reported intermittent US supply constraints for its Lantus SoloStar (Insulin Glargine) pens due to high demand, though the product has not been classified as being under a shortage; Sanofi expects supply to improve in coming weeks (read through for Biocon).

6) Johnson & Johnson received a positive CHMP opinion for Icotyde (Icotrokinra) for the treatment of moderate-to-severe plaque psoriasis, positioning it to become the first oral IL-23 inhibitor to be approved in the EU (relevant for Sun’s Ilumya).

7) Novo Nordisk will launch Extensior, an authorized lower-cost Semaglutide for type 2 diabetes, in South Africa on 27-Jul-26 through a partnership with Acino (read through for Sun).

8) The European Medicines Agency (EMA) proposed revising its biosimilar guidelines to formalize a leaner development pathway, allowing comparative efficacy studies to be waived for well-characterized biosimilars with greater reliance on analytical comparability and PK/PD data, to reduce development costs and timelines; revised draft guideline expected in 2QCY27.

9) Eli Lilly reported positive Phase 3 results, with Retatrutide delivering up to 22.6% weight loss in obesity patients with cardiovascular disease and with/without type 2 diabetes; it plans filing for US approval in 1QCY27.

10) GLP-1 weekly prescriptions rebounded strongly, with Novo Nordisk's Wegovy prescriptions rising 10.5% wow (week-on-week) to a record ~495.5k scripts (including oral Wegovy scripts); Eli Lilly's Foundayo reached a record 26.8k prescriptions, while Zepbound grew 7.7% wow, retaining 58.9% obesity market share.

11) Samsung Biologics agreed to acquire peptide CDMO PolyPeptide for CHF1.5bn ($1.8bn), expanding into peptide and GLP-1 manufacturing, advancing its capabilities beyond the production of antibodies and antibodydrug conjugates (ADCs).

News flow - Indian Pharma

1) Lupin has spun out its oncology assets LNP7457 (PRMT5) and LNP8701 (SOS1) into USbased Kaveri Therapeutics, which will advance the programs through global clinical trials. Lupin has received 82.2% equity stake, valued at $1.6mn, in the company and Kaveri plans raising additional capital to support further clinical development.

2) Rubicon Research acquired a US manufacturing facility from InvaTech Pharma Solutions at an enterprise value of $2.9mn, with commercial production expected to begin in CY27.

3) Sun Pharma has announced that the stockholders of Organon have approved the proposals related to the previously announced merger.

4) Emcure Pharmaceuticals’s co-marketed Poviztra (Semaglutide) can now be used to treat MASH following CDSCO's approval of Wegovy for the indication in India.

5) Takeda expects to launch Qdenga, India's first approved dengue vaccine, in early CY27, initially through the private healthcare market, with broader public access subject to inclusion in National Immunization Programs (NIPs).

6) JB Chemicals's subsidiary Unique Pharmaceutical Laboratories voluntarily recalled four lots of Cetirizine tablets in the US due to potential Ranitidine cross-contamination.

7) AstraZeneca Pharma India received approval to expand the label of Fasenra (Benralizumab) for treating hypereosinophilic syndrome (HES) in patients aged 12 years and older.

8) Zydus Lifesciences received approval to begin a Phase 3 trial of Desidustat in collaboration with ICMR for treating anemia in sickle cell disease.

9) Intas Pharmaceuticals received CDSCO approval for its Trastuzumab Emtansine biosimilar for HER2-positive breast cancer, becoming the second approved biosimilar in India after Zydus's Ujvira.

10) Hikal commissioned a cGMP-compliant pilot plant at its Pune R&D campus, expanding its capabilities across process development, scale-up, technology transfer, and clinical-stage manufacturing.

11) ICMR licensed three indigenous biomedical technologies to Indian pharmaceutical and vaccine manufacturers, for accelerating the development of cancer therapies and infectious disease vaccines.

12) Piramal Pharma temporarily suspended operations at its Pharmaceutical Special Economic Zone, Matoda (Ahmedabad) manufacturing facilities due to heavy rainfall and flooding in Gujarat. Also, Zydus Lifesciences temporarily suspended select operations at its Ahmedabad facilities as a precaution against torrential rain and waterlogging. The company is now gradually resuming operations, as weather conditions improve.

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