IGI Logo

This is the twentieth edition (week ending 9-Aug-26) of our Pharma Weekly – In Case You Missed It. The current edition includes a section dedicated to 2QCY26 earnings updates, with multiple global innovators/generic players reporting earnings over the last week. Key developments in the past week:

1) The USFDA approved Emerge Bioscience’s Garzulys (insulin aspart), a biosimilar to NovoLog. Meitheal holds exclusive US commercialization rights under its agreement with Emerge Bioscience (relevant for Biocon).

2) Amgen’s biosimilar portfolio grew 29% yoy to $855mn, led by Pavblu (Aflibercept) sales of $287mn, up 121% yoy (relevant for Biocon and Lupin). Prolia/Xgeva sales declined 33% yoy to $1.1bn amid biosimilar competition (relevant for Biocon, Dr Reddy’s, and Aurobindo).

3) A US federal judge temporarily blocked the Pentagon from designating WuXi AppTec as a Chinese military-linked company, citing insufficient evidence. The ruling does not permanently remove WuXi from the Section 1260H list or prevent the department from designating the company again.

4) Merck’s 2QCY26 Keytruda sales were up 4% yoy to $8.4bn, though US growth is expected to moderate as penetration peaks across key indications (read through for Zydus, Dr Reddy’s, and Biocon). For Lipfendra, Merck is focused on expanding the oral PCSK9 market (regulatory reviews ongoing in Europe and China), while also developing combination therapies (relevant for Divi’s).

5) Eli Lilly’s Foundayo sales stood at $98mn in 2QCY26, with prescriptions showing an inflection following expanded access, DTC promotion, and the Medicare GLP-1 Bridge program; the drug is now under review in more than 40 markets, supporting its global rollout potential (read-through for Divi’s).

6) BioCryst Pharma reported Orladeyo revenue of ~$158mn in 2QCY26, up 10% yoy. FY26 revenue guidance was maintained at $625-645mn, while pediatric Orladeyo pellets saw strong early traction (read-through for Sai Life).

7) Pfizer reported Nurtec revenue of ~$420mn in 2QCY26, up 18% yoy (relevant for Anthem and Piramal). Cibinqo revenue grew 38% yoy to $94mn; Mevrometostat is advancing through Phase 3 (both relevant for Laurus Labs).

8) Rhythm Pharma reported Imcivree revenue of ~$70mn in 2QCY26, up 19% qoq, driven by strong US demand. The product is expected to be launched in Japan in 4QCY26 and in Germany in 1HCY27. Supernus Pharma reported Qelbree sales of ~$89mn in 2QCY26, up 15% yoy (relevant for Neuland).

9) Vertex Pharma’s Alyftrek revenue reached ~$575mn in 2QCY26, up 265% yoy, driven by continued Trikafta switching and strong US/Europe uptake (relevant for Laurus). Journavx revenue stood at $50mn, up 71% qoq (relevant for Laurus Labs and Anthem).

10) Acadia reported Daybue sales of $125mn in 2QCY26, up 30% yoy. The company raised CY26 Daybue guidance to $480-510mn and remains confident of reaching $700mn by CY28. ACP-211 is advancing in Phase 2 for a major depressive disorder (relevant for Sai Life).

11) Zoetis reported Simparica franchise sales of $442mn, flat yoy, with 19% international growth offset by a 6% decline in the US (relevant for Sai Life). Librela + Lenivia generated $105mn in sales in 2QCY26, down 8% yoy, although early response to the launch of Lenivia in Europe and Canada is encouraging, per the management (relevant for Syngene).

12) Insmed reported Brinsupri revenue of ~$310mn in 2QCY26; the company raised its CY26 revenue guidance to $1.25-1.4bn and peak sales expectations to >$7bn (read-through for Anthem)

News flow – Indian Pharma

1) Biocon launched Yesafili (Aflibercept), its interchangeable biosimilar to Eylea 2mg, in the US, enabling pharmacy-level substitution subject to state laws. The product had received USFDA approval and an interchangeable designation in May-24.

2) Sun Pharma initiated a precautionary withdrawal of several ophthalmic products in India, including Depopred, Brinolar, Brinzotim, Lotepred, Nepalact, and related eye drops; it instructed distributors to immediately stop billing and to return existing stocks.

3) Piramal Pharma Solutions launched a new spray drying suite at its Turbhe peptide facility. The closed-loop facility supports small-volume, high-potency batches and enables controlled processing to improve peptide stability, solubility, and bioavailability.

4) Gland Pharma and Neuland announced a long-term CDMO partnership, with Gland setting up a dedicated sterile API manufacturing suite at its Visakhapatnam facility for microparticle depot products, adding ~1,400kg annual capacity.

5) Dr Reddy’s has terminated its Feb-22 agreement with Novartis India for distribution and promotion of select brands, with the company continuing to commercialize the products till 30-Sep-26. Following termination, Novartis India will re-acquire exclusivity and market access for the covered products.

6) Gland Pharma signed a strategic Manufacturing and Supply Agreement (MSA) with a global pharma company for manufacturing and supply of 55 sterile injectable SKUs across three sites, covering oncology and non-oncology products in the vial, lyophilized, ampoule, and PFS formats. Technology transfer is expected to be completed within two years, with revenue starting from CY29, with annualized revenue potential of $90-100mn once all products are commercialized.

7) AstraZeneca Pharma India received CDSCO approval for an additional indication of Enhertu (Trastuzumab Deruxtecan) for adjuvant treatment of HER2-positive breast cancer patients with residual invasive disease, following neoadjuvant therapy.

8) Dr Reddy’s Laboratories registered a new Phase 1 trial for its proposed Abatacept biosimilar, evaluating auto-injector and prefilled syringe formulations for pharmacokinetic comparability, safety, and tolerability in 160 participants.

9) The Delhi High Court sought responses from Novartis, Astex Therapeutics, and the Controller of Patents on Natco Pharma’s challenge to a patent granted for Ribociclib, with Natco alleging double patenting and unlawful extension of patent protection.

10) The Indian Pharmaceutical Alliance (IPA) has asked pharma companies to identify legacy drugs marketed in India without clear CDSCO approvals, seeking their regularization by the regulator. Examples include sodium valproate modified-release tablets, carbamazepine tablets, and lithium carbonate prolonged-release tablets, where certain strengths are not reflected in CDSCO’s central approval records.

For More  Emkay Global Financial Services Ltd Disclaimer http://www.emkayglobal.com/Uploads/disclaimer.pdf & SEBI Registration number is INH000000354