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This is the twenty-seventh edition (week ending 27-Sep-26) of our Pharma Weekly – In Case You Missed It. Key developments in the past week:

1) Biocon has completed its Phase 1 trial, comparing Bmab3000 (Trastuzumab SC biosimilar) with Roche's Herceptin Hylecta, evaluating pharmacokinetics, immunogenicity, safety, and tolerability after a single 600mg subcutaneous dose in 150 volunteers.

2) Biocon lost its bid to challenge a Regeneron patent covering Eylea HD (Aflibercept 8 mg) after the USPTO denied its post-grant review request. The USPTO ruled that Biocon had missed the statutory nine-month filing window and refused to let it join Alvotech's existing challenge. Regeneron views biosimilar launches of high-dose Eylea HD in CY27 as highly unlikely, citing Phase 3 trial timelines and patent protection. Rival trials are expected to complete around Jul27, while Eylea HD’s core patent extends till May-39.

3) Novo Nordisk announced that CagriSema, its once-weekly combination of Cagrilintide and Semaglutide, demonstrated greater weight loss than Eli Lilly’s Mounjaro in a Phase 3 trial, and FDA approval is expected in 4QCY26.

4) NewAmsterdam Pharma and Menarini received a positive CHMP opinion recommending EU marketing authorization for Obicetrapib 10mg (Ubeslo) and its fixed-dose combination with Ezetimibe (Evlarco) for LDL-C reduction; the European Commission’s final decision is expected later this year (relevant for Neuland, Piramal, Aarti Pharmalabs, and Blue Jet).

5) Eli Lilly has received FDA approval for Onswik (Insulin Efsitora), a once-weekly basal insulin for adults with type 2 diabetes, with Phase 3 trials demonstrating non-inferior HbA1c reduction versus daily basal insulins. Lilly plans to launch Onswik in the US in coming months (relevant for Biocon).

6) Merck highlighted broad early payer access for Lipfendra (indicated for LDL-C reduction), priced to maximize access, and expects full commercial coverage for most lives by end-CY27 and Medicare coverage by CY28. It also plans to list Lipfendra on TrumpRx in 2HCY26 under its MFN agreement (relevant for Divi’s, Neuland, Piramal, and Blue Jet).

7) J&J highlighted a strong Icotyde (oral IL-23) launch, with ~17,000 patients treated (60% systemic-naive) and ~7,000 prescribers for plaque psoriasis, and full US commercial coverage. It expects psoriatic arthritis data and filing by endCY26 (relevant for Sun Pharma).

8) Amgen’s Keytruda biosimilar met both its primary and secondary endpoints in Phase 3, with regulatory submissions planned for 2HCY26. The company’s BLA for an Opdivo biosimilar has been accepted by the USFDA, with FDA decision expected by end-CY26 (relevant for Biocon, Zydus, Dr Reddy’s, and Ipca).

9) Vertex highlighted the global roll out of Alyftrek (indicated for cystic fibrosis). The drug is approved across regions, is gaining naïve patients with ultra-raremutations, and is being extended to patients aged 2-5. Vertex also noted that realworld lung-function data have helped it hold ex-US prices steady (relevant for Laurus Labs).

10) The US Treasury is considering rules that would allow pharma companies to continue licensing deals with Chinese biotech firms, provided investments do not involve pathogens or potentially weaponizable biotechnology.

11) The US Department of Commerce issued guidance on tariff exemptions under Section 232 pharma tariffs, covering specified products including orphan drugs, plasma-derived therapies, cell and gene therapies, ADCs, and medical countermeasures. Exempt jurisdictions include India, the EU, Japan, and the UK

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