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This is the eleventh edition (week ending 19-Apr-26) of our Pharma Weekly – In case you missed it. Key developments in the past week:

1) Dr Reddy’s’ Semaglutide (Embeltah) registration request was rejected by Brazil’s ANVISA due to deficiencies in technical requirements. Meanwhile, Hetero Labs aims to sell ~1.5mn Semaglutide pens in the first year across markets and launch in >75 countries (including Canada in the next 18 months).

2) Amneal has launched gProAir (Albuterol) and gQVAR in the US, the company’s first two metered-dose inhalation (MDI) launches (read-through for Lupin and Cipla).

3) Eli Lilly plans a Type 2 Diabetes submission for Foundayo (Orforglipron) by the end of 2QCY26, even as the USFDA has requested additional liver safety data and post-marketing studies (relevant for Divi’s).

4) J&J has launched its psoriasis pill, Icotyde (Icotrokinra - oral IL-23 receptor antagonist), post Mar-26 approval with strong early uptake, positioning it alongside Tremfya as a key growth driver amid a sharp decline in Stelara sales (-60% YoY in 1QCY26) and supporting the company’s CY26 revenue outlook of ~USD100bn (we do not perceive Icotyde as a meaningful threat to Sun’s Ilumya; link to our note).

5) Sun Pharma’s UNLOXCYT has received the USFDA’s regulatory review period determination, paving the way for a potential patent term extension (~200 days).

6) J&J reported Rybrevant + Lazcluze sales of USD257mn (+80% YoY) in 1QCY26, with sequential growth of ~19% being driven by a strong uptake across markets and share gains in both first- and second-line treatment (readthrough for Cohance).

7) Evommune will advance EVO756 into Phase 2b for migraine, with top-line data for chronic urticaria expected in 2QCY26 and an atopic dermatitis readout expected in 2HCY26 (relevant for Piramal Pharma).

8) ADC updates: Piramal Pharma has partnered with Ajinomoto Bio-Pharma Services to support ADC development and manufacturing; BioNTech reported positive Phase 2 results for Trastuzumab Pamirtecan (a potential competitor to Enhertu) in HER2-expressing and advanced endometrial cancer, and has plans for a CY26 BLA filing; GSK is progressing its B7-H4-targeted ADC in platinumresistant ovarian cancer and advanced endometrial cancer into Phase 3, while Eli Lilly will acquire ADC-focused CrossBridge Bio in a deal worth up to ~USD300mn, adding preclinical dual-payload oncology assets to its pipeline.

9) The DCGI has proposed easing biosimilar approval norms with reduced emphasis on bioequivalence studies and more focus on characterization, to demonstrate equivalence, bringing its norms at par with the standards in regulated markets.

News flow – Indian Pharma

1) Dr Reddy’s’ Semaglutide (Embeltah) registration request was rejected by Brazil’s ANVISA due to failure to meet technical requirements on efficacy, safety, and quality. Cipla’s Liraglutide applications were rejected on similar grounds. 2) Dr Reddy’s (Aurigene) and Alveus Therapeutics have advanced their metabolic disease collaboration with the nomination of ALV-200, an AMYR3 peptide candidate, for development.

3) Sun Pharma and Germany’s Grünenthal are evaluating binding bids for Organon, with Sun pharma having secured commitments from a group of overseas banks.

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