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This is the twenty-eighth edition (week ending 4-Oct-26) of our Pharma Weekly – In Case You Missed It. Key developments in the past week:

1) Biocon has began recruiting patients for its Phase 1 trial comparing Bmab1800, its proposed Keytruda (Pembrolizumab) biosimilar. The randomized, double-blind study plans to enroll 138 patients, with primary completion expected by 15-Dec27. Meanwhile, STADA has partnered with China's SBP Group for biosimilars, under which SBP will develop, manufacture, and supply a proposed Keytruda (Pembrolizumab) biosimilar, with STADA holding exclusive commercial rights in the EU, Switzerland, the UK, and CIS, plus options for the US and GCC (readthrough for Biocon, Dr Reddy's, Ipca, and Zydus).

2) Eli Lilly's Olumiant (Baricitinib) received USFDA approval for severe alopecia areata in patients aged 12 and above, with 42% of patients on the 4mg dose achieving at least 80% scalp hair coverage in the Phase 3 trial (relevant for Sun Pharma's Leqselvi, which is approved only for adults and is undergoing an investigator-led trial in this age group).

3) The Centers for Medicare & Medicaid Services (CMS) has finalized the GLOBE Model, requiring manufacturers to pay rebates on certain high-spend Medicare Part B drugs whose US prices exceed international benchmarks across 19 reference countries, starting 1-Jan-27. The final rule has sharply narrowed its scope by exempting manufacturers in the voluntary GENEROUS Model (consequently, companies like Sun Pharma will be exempt).

4) Wave Life Sciences aligned with the USFDA on a single two-year registrational trial for WVE-006, its RNA-editing therapy for alpha-1 antitrypsin deficiency (AATD), with a one-year interim analysis to support potential accelerated approval based on AATD biomarkers. Data from the 600mg monthly dose cohort of the ongoing Phase 1b/2a trial are expected in 4QCY26 (read-through for Cohance).

5) Eli Lilly presented full Phase 3 data showing its oral GLP-1 Foundayo (Orforglipron) was non-inferior to insulin glargine on cardiovascular safety in adults with type 2 diabetes, obesity, and high cardiovascular risk. Compared with insulin glargine, Foundayo lowered cardiovascular death by 53% and all-cause mortality by 57%. It also cut A1C by 1.6% against 1.0% and reduced weight by 8.8% against a 1.7% gain at 52 weeks (read-through for Divi’s).

6) Novo Nordisk has escalated its oral semaglutide patent battle in India, objecting to Torrent's court undertaking on the SNAC concentration in its product and seeking to verify Sun Pharma's claims about its oral version. On a related note, Eli Lilly's Orforglipron and Novo Nordisk's oral Wegovy (Semaglutide) are expected to launch in India in 1HCY27, with both already filed with Indian regulators and Orforglipron likely to launch first, around Jan-Feb-27.

7) Kodiak Sciences's Tarcocimab (Zenkuda) and Tabirafusp both matched Eylea (Aflibercept) on vision gains in the Phase 3 trial in wet AMD. More than half of patients on Tarcocimab were maintained on 24-week dosing in year one, vs every eight weeks for Aflibercept. Kodiak plans to file Tarcocimab with the USFDA in 4QCY26 (read-through for Eylea biosimilars).

8) Lilly presented full Phase 3 data for Retatrutide in adults with obesity and type 2 diabetes, with the 12mg dose delivering 20.8% mean weight loss at Week 80 vs 4% for placebo, and 34.9% of patients losing at least 25% of their body weight. Lilly plans to file for USFDA approval in 1QCY27. Lilly's eloraTZP, a combination of its amylin agonist Eloralintide with Tirzepatide, delivered 23.3% average weight loss at 48 weeks in a Phase 2 trial, topping Retatrutide. However, up to 27% of patients discontinued treatment, mainly due to GI side effects. Lilly plans to start Phase 3 trials for this combination in 4QCY26.

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