We have a pipeline of 8 biosimilar products (produced by recombinant biotechnology in E.coli) at various stages of development, including 2 whose pre-clinical toxicity studies are completed, 2 in confirmatory clinical trials and 1 in pre-clinical toxicity studies.

Somatropin For Injection Ph.Eur

• PCT's have been filed and National Phase filings are under progress in various countries.
• Non-solvent (aqueous) based drug substance purification process
• Pre-clinical toxicity studies have been successfully completed as per schedule Y of Drugs & Cosmetics Act, India.
• Confirmatory safety & efficacy clinical trial (phase-III) is in progress and expected to complete by July 2011

Teriperatide Injection

• Drug: Biologically active N-terminal portion of Parathyroid Hormone.
• IN and PCT applications have been filed.
• Non-infringing Cloning, Fermentation and Purification technology
• Pre-clinical toxicity studies have been successfully completed as per schedule Y of Drugs & Cosmetics Act, India.
• Confirmatory Safety & Efficacy clinical trial (phase-III) is in progress and expected to complete by July 2011.

Platelet Derived Growth Factor (PDGF-BB) Gel

• Drug Class: Growth Factor
• INN: Becaplermin
• Novel cloning, Fermentation and purification technology
• Developed novel gel formulation; Indian patent is filed.
• Pre-clinical toxicity studies have been successfully completed as per schedule Y of Drugs & Cosmetics Act, India.

Filgrastim Injection (G-CSF)

• Drug Class: Colony stimulating factor
• Non-infringing Cloning, Fermentation and Purification technology
• Non-solvent (aqueous) based drug substance purification process
• Sentence has been removed
• Drug Substance is complying with Ph.Eur monograph specifications.
• Pre-clinical toxicity studies as per EMEA Biosimilar guideline for Filgrastim are completed using Neupogen® of Amgen, Germany as reference product.
• Confirmatory safety & efficacy clinical trial (phase-III) is about to start.

PEG-Filgrastim Injection (PEG-GCSF)

• Drug Class: Pegylated colony stimulating factor to increase the serum half-life.
• Non-infringing aqueous based pegylation and purification technology
• Physico-chemical comparability with Neulasta® of Amgen, Germany is established.
• PCT application has been filed.
• Pre-clinical toxicity studies as per EMEA Biosimilar guideline are underway using Neulasta® of Amgen, Germany as reference product and will be completed by Sept 2011.

For all the above products, the cell banks (MCB & WCB) are prepared and characterized as per ICH Q5B & Q5D guidelines. And also both the Drug substance and drug product are completely characterized as per ICH Q6B guideline and compared with the reference medicinal products.