Biosimilars

Cutting-edge products that save life

Biosimilars Program

Biogenomics has a very active Biosimilars development program. Our recombinant DNA based technology platform can be adapted to a wide range of biopharmaceuticals. The first phase of the Biosimilars Development Program at Biogenomics has generated a pipeline of eight Biosimilars. A second development phase is due to produce seven more products.

The entire process development is conducted completely in-house. At Biogenomics, a typical time frame for product development - from concept to scale-up is six months or shorter. Biogenomics is the first Indian company to successfully develop an indigenous Recombinant Human Insulin Program that relies entirely on proprietary clones/cell lines/technology for its drug development program in Biosimilars

Our microbial-platform-based Biosimilars program has been successfully scaled up at Puducherry, where a state-of-the-art manufacturing facility for E.coli based biopharmaceuticals is located. The platform technology for each of the biosimilars typically begins with fermentation where there is over expression of the desired target protein. The cells are harvested and lysed to release expressed recombinant protein in the form of inclusion bodies. The inclusion bodies are washed, solubilized and folded. These solubilized folded inclusion bodies containing primarily, the target protein, is purified using column chromatographies, enzymatic conversions, and lyophilizations.

Our expertise in developing Recombinant Proteins ranges from synthesizing the coding sequence, using our indigenous process, formulation and aseptic fill-finish. Biogenomics has completed the development of Recombinant Human Insulin and it analogs (long acting and short acting), granulocyte colony stimulating factor and its PEGylated forms, Interferon-2a and its PEGylated version amongst various other products.

Biosimilars Products

Recombinant Human Insulin

Recombinant Human Insulin decreases the levels of glucose in the blood and regulates the metabolism of glucose, fats and proteins Used in the treatment of type I and type II diabetes . Biogenomics’ Recombinant Insulin product is a steriletherapeutic protein manufactured at its state-of-the-art facility by indigenous rDNA platform technology from E.coli bacterial cell right from clone development to end product for its commercialization.

Recombinant Insulin is clear colourless sterile formulation and will be available in 10 mL vial (40 IU/ml, 100 IU/mL) and 3 mL cartridges (100 IU/mL).

The ingredients used to manufacture the API and sterile formulations, is fully Animal Origin Free so as to avoid adventitious agents posing the risk of TSE/ BSE for any irreversible fatal effects on human health.

Biogenomics’ Insulin is currently being tested against reference product for pre-clinical evaluation as approved by Indian regulatory authority.

Recombinant Insulin Aspart

Insulin Aspart protein is homologous with regular human insulin with the exception of a single substitution of the amino acidproline by aspartic acid at position B28. In comparison with human insulin when using the same basal insulin, Insulin Aspart provide comparable glycaemic control with a reduced risk of hypoglycaemia.

Used in Diabetes mellitus for the control of hyperglycaemia. Biogenomics’ Insulin Aspart is a steriletherapeutic protein manufactured at its state-of-the-art facility by in-house rDNA platform technology from bacterial E.coli cells right from clone development to end product for its commercialization.

Insulin Aspart is clear colourless sterile formulation and will be available in 10 mL vial (100 U/mL) and 3 mL cartridges (100 U/mL).

The ingredients used to manufacture the API and sterile product, is fully Animal Origin Free so as to avoid adventitious agents posing the risk of TSE/ BSE for any irreversible fatal effects on human health. Biogenomics’ Insulin Aspart is currently being tested against reference product for pre-clinical evaluation as approved by Indian regulatory authority.

Recombinant Insulin Lispro

The unique structure of Insulin Lispro analog, compared to regular human insulin, results in a faster rate of absorption from subcutaneous sites of injection, a more rapid effect and a shorter duration of action, more closely mimicking the normal physiological response.

Insulin Lispro is indicated to improve glycemic control in adults and children with diabetes mellitus.

Biogenomics’ Recombinant Insulin Lispro is a steriletherapeutic protein manufactured at its state-of-the-art facility by indigenous rDNA platform technology from bacterial E.coli cells right from clone development to end product for its commercialization.

Insulin Lispro is clear colourless sterile formulation and will be available in 10 mL vial (100 IU/mL) and 3 mL cartridges (100 IU/mL).

The ingredients used to manufacture the API and sterile product is fully Animal Origin Free so as to avoid adventitious agents posing the risk of TSE/ BSE for any irreversible fatal effects on human health. Biogenomics has tested Insulin Lispro against the reference product for pre- clinical evaluation and further regulatory approval is under process.

Recombinant Insulin Glargine

Insulin Glargine is identical inprimary structure of human insulin, only differing in amino acid sequence at position 21 inthe A-chain and in the B chain containing 2 additional amino acids at the C-terminal end. InsulinGlargine release profile is flat compared to Insulin formulations. Insulin Glargine is used in paediatrics and adults with Type I diabetes mellitus (DM). It is also used for adults with Type II DM who require long- acting basal insulin replacement.

‘Biogenomics’ Recombinant Insulin Glargine is a steriletherapeutic protein manufactured at its state-of-the-art facility by indigenous rDNA platform technology from bacterial E.colicells right from clone development to end product for its commercialization.

Insulin Glargine is clear colourless formulation and will be available in 10 mL vial (100 IU/mL) and 3 mLcartridges (100 IU/mL).

Biogenomics’ Insulin Glargine is currently being tested against reference product for pre-clinical evaluation as approved by Indian regulatory authority.

Recombinant Interferon Alpha 2a

Interferon alfa-2amediates the response of host cell’s immune system to the invasions by bacteria’s, viruses, tumourous cells and any foreign particles. It therefore acts as an antiviral and a cellular growth suppressing agent. The product is used in the treatment of chronic hepatitis C, hairy cell leukemia, AIDS-related Kaposi's sarcoma, and chronic myelogenous leukemia.

Biogenomics’ Recombinant Interferon Alpha 2a is a steriletherapeutic protein manufactured at its state-of-the-art facility by indigenous rDNA platform technology from bacterial E.coli cells right from clone development to end product for its commercialization.

Interferon Alpha 2a is clear colourless formulation available inprefillable syringe of 3 MIU /0.5 mL.

Biogenomics’ has testedInterferon Alfa-2a against the reference product for pre-clinical evaluation. Currently being tested for Clinical Trial as approved by Indian regulatory authority.

Recombinant Human PEG-Interferon Alpha 2a

Recombinant Pegylated Interferon Alpha 2a (Pegylated with a branched 40 kDa PEG chain) is an antiviral drug and has a dual mode of action, both antiviral and on the immune system. The addition of polyethylene glycol to the interferon, through a process known as pegylation, enhances the half-life of the interferon when compared to its native form used for the treatment of chronic hepatitis C.

‘Biogenomics’ Peginterferon Alfa-2a is a steriletherapeutic protein manufactured at its state-of-the-art facility by in-house rDNA technology using bacterial E.coli cells from clone development to end product for its commercialization.

Peginterferon Alpha 2a is clear colourless formulation available as 135 mcg/ 0.5mL and 180 mcg/0.5mL.

Biogenomics has tested Peginterferon Alfa-2a against the reference product for pre-clinical evaluation. Currently being tested for Clinical Trial as approved by Indian regulatory authority.

Recombinant Human Granulocyte Colony Stimulating Factor (rHu-GCSF)

Recombinant Human Granulocyte Colony Stimulating factors rH-GCSF preferentially promotes proliferation and differentiation of progenitors of polymorphonuclear leucocytes and induces terminal differentiation of some myeloid leukemia cells.

It is used for treating neutropenia caused by cancer chemotherapy. In addition to its effect on hematopoiesis, G-CSF also enhances neutrophil functions against bacteria, fungi and tumor cells mediated by ADCC.

rH-GCSF is a sterile therapeutic protein manufactured at its state-of-the-art facility by in-house rDNA platform technology from bacterial E.coli cells right from clone development to end product for its commercialization.

rH-GCSFis clear colourless formulation packed in prefillable syringe 300 mcg/0.5mL.

Biogenomics’ rH-GCSF is currently being tested for pre clinical evaluation as approved by Indian regulatory authority.

Recombinant Human Pegylated Granulocyte Colony Stimulating Factor

Pegylation of GCSF proteins increases half-life, reduces antigenicity, increases solubility and reduces degradation by proteolysis without losing any biological activity.

Used for treatment of neutropenia caused by cancer chemotherapy. PEG-GCSF is a sterile therapeutic protein manufactured at its state-of-the-art facility by in-house rDNA platform technology from bacterial E.coli cells right from clone development to end product for its commercialization.

PEG-GCSF is clear colourless formulation packed in prefillable syringe of 6 mg/0.6 mL.

Biogenomics’ PEG-GCSF is currently being tested against reference product for pre clinical evaluation as approved by Indian regulatory authority.

Biosimilars Strategy

ACTIVE PHAMACEUTICAL INGREDIENTS (APIs)

Biogenomics has a state-of-the-art facility for manufacturing of bulk APIs. These APIs are of highest quality and meet compendia qualitites (wherever applicable).

BULK PRODUCT FORMULATION

Biogenomics facility is equipped to supply bulk formulations of Biosimilars so that these could be fill-finished at appropriate facilities.

FINISHED PRODUCT FORMULATION

Biogenomics facility has Aseptically Processed Injectable Formulations (APIF) facility in Puducherry, India for undertaking clinical trial production as well as commercial production of small volume parenteral products derived from biotech processes for local as well as export submissions / markets.

The key objectives behind the facility are as follows.

The facility is designed for producing vials; pre filled syringes as well as cartridges on campaign basis.

The facility is designed for biotech derived products. This formulation portions is being located adjacent to the main biotech API facility. The facility is designed for with full flexibility to produce all the presentations of pipeline products.

With fully integrated ‘Bench to Manufacturing’ facilities, BioGenomics ensures a quick turnaround, adaptive technology and is capable of full-scale manufacturing.

Biogenomics is consistently able to meet and exceed all regulatory standards in its products, processes and facilities.

Biosimilars Commercialization Strategy

Biogenomics is actively seeking global partners for the development and commercialization of our Biosimilars. Our strategy is to establish proof-of-concept in man in Indian clinical trials and generate data to satisfy global regulatory and commercial standards in partnership or licensing agreements with strategic partners.

Please contact business.development[at]biogenomics.co.in for further information.