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Biopharmaceuticals

- Biosimilars

Biocon has leveraged its core strength of fermentation technology to develop a wide portfolio of generic Insulins and Analogs, biosimilar Monoclonal Antibodies (MAbs) and recombinant proteins. We have emerged as a significant global player by reinforcing our scale, competence and pioneering technology capabilities.

As the Biosimilars opportunity unfolds, Biocon is at the right place, at the right time. We are rapidly growing our development, regulatory and clinical expertise, along with world class manufacturing capabilities, to make therapies affordable to patients, on a global scale. We are well positioned to contribute towards lowering costs and increasing access to this highly innovative class of drugs.


The Biosimilars opportunity is set to expand as patents expire on leading biologics and patients demand lower priced drugs. A number of top-selling biologics are due to lose product patent protection over the next 5-7 years, opening up a wealth of new possibilities for biosimilars players. Key therapy areas such as cancer, diabetes and rheumatoid arthritis will spearhead this new wave of biosimilars. Biocon is well placed to leverage many of these opportunities. Building on our India experience, we have begun unlocking value in other emerging markets with Recombinant Human Insulin (rh-Insulin), Insulin Analogs and Monoclonal Antibodies (MAbs), key products of our Biosimilars portfolio.

Generic Insulins & Analogs
At Biocon, we are developing a range of affordable basal, rapid and intermediate acting generic insulins for patients worldwide. The portfolio comprises Recombinant Human Insulin (rh-Insulin), Insulin Glargine, Insulin Aspart and Insulin Lispro. Our generic insulins portfolio targets a US$20 billion market opportunity as per 2014 sales of innovator reference products.


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Human Insulin

Insulin exerts effect on glucose metabolism by binding to Insulin receptors throughout the body. Upon binding, Insulin promotes the cellular uptake of glucose into fat and skeletal muscle and inhibits hepatic glucose output, thus lowering the blood glucose. Based on the time-action profile of Insulin, Biocon has developed two kinds of insulin:

1. Short acting - Insulin Regular - Used to control post-meal     surge in glucose level
2. Intermediate/Longer acting- Insulin NPH- Used to control     fasting glucose levels.

Insulin therapy involves patients taking these two types of Insulin one or many times during the day depending on the type and stage of diabetes. To enhance the convenience of therapy, we have combined the above types of Insulin, e.g. Insulin 30/70 containing 30% regular insulin and 70%, Insulin NPH and Insulin 50/50 containing 50% regular Insulin and 50% Insulin NPH.


Indications:
- Type 1 diabetes mellitus
- Type 2 diabetes mellitus uncontrolled on maximal combination    therapy with oral agents
- Gestational diabetes
- Hyperglycemic emergencies such as diabetic ketoacidosis and   hyperosmolar Non-ketotic coma
- Total pancreatectomy patients
- Acute or chronic hyperglycemia provoked by:
  - Infection or trauma
  - Chronic medical illnesses
- Major surgery - Other types of secondary diabetes.

Biocon is the 4th largest producer of Recombinant Human Insulin using proprietary technology. Biocon’s Insulin is produced by DNA recombinant technology using a yeast, Pichia pastoris.


Insulin Glargine

Insulin Glargine is long-acting biosynthetic human insulin analog. This analog results from elongation of the C-terminal end of insulin B chain by 2 positively charged amino acid residues, as well as a substitution of an amino acid residue at a certain point. These modifications lead to a shift in the isoelectric point, rendering the insulin analogue less soluble at physiological pH levels. Therefore the insulin analogue retains its glucose lowering property for 24 hours without a pronounced plasma peak with just one injection. Due to this nature, the insulin analogue is preferred for maintaining the basal insulin level throughout the day.

Insulin Glargine is manufactured from recombinant DNA technology using the yeast, Pichia Pastoris. The mode of action is the same as that of Insulin. Insulin analogue binds to receptors and promotes cellular uptake of glucose into fat and skeletal muscle and inhibits hepatic glucose output, thus lowering the blood glucose.

Indications:
- Type 1 diabetes mellitus
- Type 2 diabetes mellitus


Insulin Lispro

Insulin Lispro is a short-acting human insulin analogue obtained by altering the normal form of insulin. Switching the amino acids at 2 positions on the insulin B chain prevents the analogue from self aggregating in solution and therefore is more rapidly absorbed than human regular insulin. The onset of action is 10-20 minutes with peak of 1-3 hours and lasts 3-5 hours. It is taken 5-10 minutes before a meal to stabilize post meal glucose levels. Due to its rapid onset of action, it affords a more flexible treatment regime with a lower risk of developing hypoglycemia. And hence, short acting analogues are fast becoming the preferred mode of insulin control.

Insulin Lispro is manufactured from recombinant DNA technology using the yeast, Pichia Pastoris. The mode of action is the same as that of Insulin. Insulin analogue binds to receptors and promotes cellular uptake of glucose into fat and skeletal muscle and inhibits hepatic glucose output, thus lowering the blood glucose.


Indications:
- Type 1 diabetes mellitus
- Type 2 diabetes mellitus


Insulin Aspart

Insulin Aspart is a short-acting human insulin analog obtained by altering the normal form of insulin. Substituting the amino acid at a certain position by a more negatively charged amino acid on the insulin chain, prevents the analog from self aggregating in solution and therefore is more rapidly absorbed than human regular insulin. The onset of action is 10-20 minutes with peak of 1-3 hours and lasts 3-5 hours. It is taken 5-10 minutes before a meal to stabilize post meal glucose levels. Due to its rapid onset of action, it affords a more flexible treatment regime with a lower risk of developing hypoglycemia. And hence, short acting analogues are fast becoming the preferred mode of insulin control.

Insulin Aspart is manufactured from recombinant DNA technology using the yeast, Pichia Pastoris. The mode of action is the same as that of Insulin. Insulin analogue binds to receptors and promotes cellular uptake of glucose into fat and skeletal muscle and inhibits hepatic glucose output, thus lowering the blood glucose.


Indications:
- Type 1 diabetes mellitus
- Type 2 diabetes mellitus


Monoclonal Antibodies & Other Biologics

Biocon has gained global recognition for being one of the key players in developing Monoclonal Antibodies (MAbs) and recombinant proteins. We have made significant investments in clinical development and manufacturing and strategic partnerships over the years.

Biocon and Mylan have one of the longest-standing partnerships in the global biosimilars space with a strong position in a promising industry. The Biocon-Mylan partnership includes six biosimilar programs (Trastuzumab, Pegfilgrastim, Adalimumab, Bevacizumab, Etanercept and Filgrastim).


Biocon's Oncology Portfolio


The quest for a cost-effective treatment for one of the most prevalent forms of cancer in India led Biocon to develop a novel biologic, Nimotuzumab, for head and neck cancer. Thousands of patients have benefited from this product, sold under the brand name BIOMAb EGFR®, in less than a decade since its introduction in India.

Biocon, in collaboration with our global partner Mylan, also successfully developed the world's first follow-on Trastuzumab, which we launched in India as CANMAb™ in 2014. CANMAb™ provides an affordable treatment option for HER2-positive metastatic breast cancer patients. The clinical trials for our Trastuzumab targeted at receiving global approvals are making good progress.

Biocon, in collaboration with Mylan has received approval for its biosimilar Trastuzumab by the US FDA. This is the first Biosimilar from India to be approved in the US. OgivriTM is the first FDA-approved biosimilar to Herceptin and the first biosimilar from Mylan and Biocon´s joint portfolio approved in the U.S. This approval is thus a huge validation of the strength of our science, quality of our teams and our ability to execute science programs for hard-to-make and complex products like biosimilars.

In addition to Trastuzumab, our biosimilars portfolio includes two other oncology targeting molecules which are in the clinic, namely Pegfilgrastim and Bevacizumab.


Biocon’s Immunology Portfolio


Biocon’s focus on autoimmune diseases encompasses the development of novel biologics as well as biosimilars.
We successfully developed and launched ALZUMAb, the world’s first anti-CD6 MAb for psoriasis, in India in 2013. It is our second approved novel biologic which we believe holds immense potential for several other autoimmune conditions and is under development for some of them.

Our partnered biosimilar Adalimumab, currently in global Phase III clinical trials, will also provide a high-quality biosimilar alternative to patients suffering from various autoimmune diseases across the world.

Today, Biocon has one of the largest portfolios of generic insulins and biosimilar therapeutics in advanced stages of development for approvals in the developed markets.

We are confident that, together with our partners around the world, we can build a strong global presence in biosimilars to address the huge need for affordable access to these life-saving and life-enhancing biologics.



 

 
 
 
 
 
     
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