Question 1

What GLP-1 biosimilars does Amogen manufacture?

Accepted Answer

Amogen manufactures semaglutide and liraglutide biosimilar APIs using Saccharomyces cerevisiae recombinant fermentation at Plant 1, Hyderabad. Semaglutide is currently in Phase 1 clinical development targeting Q4 2026 first patient.

Question 2

What is Amogen Pharma's manufacturing capacity?

Accepted Answer

Amogen operates 980 Kg total GLP-1 fermentation capacity at Plant 1, Hyderabad — comprising five 15KL fermenters and two 1KL fermenters, making it one of the largest dedicated GLP-1 API facilities in India.

Question 3

Which markets is Amogen open to partnering in?

Accepted Answer

Amogen is open to biosimilar API supply and licensing partnerships across India, GCC, ASEAN, Canada, selected Africa and CIS, selected LATAM, European Union and North America.

Question 4

Why does Amogen use Saccharomyces cerevisiae instead of E. coli?

Accepted Answer

Amogen's S. cerevisiae expression system mirrors the innovator's host system used by Novo Nordisk, delivering salt-free APIs with correct higher-order structure and solubility at commercial scale above 1000 Kg — advantages that E. coli and synthetic SPPS routes cannot replicate.

Question 5

What does Amogen provide to biosimilar partners?

Accepted Answer

Amogen provides drug substance API supply, drug product in pen or cartridge format, analytical packages for DS and DP, ICH-compliant pre-clinical toxicology reports, regulatory and market access support, and long-term volume-linked pricing with secured GLP-1 capacity.

GLP-1 & Peptide Biosimilar Development Pipeline

GLP-1 Receptor Agonists

Semaglutide

Liraglutide

Tirzepatide

Dulaglutide

Insulin Analogs

Insulin Degludec

Insulin Aspart

Insulin Degludec + Aspart

Insulin Degludec + Liraglutide

Immunology

Certolizumab

Anakinra

Oncology

Pembrolizumab

Nivolumab

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