As one of the earliest players in the realm of biologics in India, we had forayed into novel biologics ahead of our entry into the biosimilars segment. Today, we have created a rich pipeline of novel and biosimilar assets aimed at addressing local as well as global unmet medical needs associated with both chronic and acute conditions. We have a rich pipeline of biosimilar molecules as well as novel biologics.
Biocon has one of the largest global biosimilars portfolios, spanning recombinant human Insulin (rh-Insulin), insulin analogs, monoclonal antibodies and other biologics for diabetes, oncology and immunology. We have built multiple commercial scale manufacturing platforms with capacities to support a global play and have successfully commercialized several of our biosimilars in various markets across the globe.
We are at an advantageous early mover position as the global markets have begun to accept biosimilars and the role they are expected to play in increasing access to high quality and yet affordable products and improve quality of life for patients around the world.
Biocon’s Global Biosimilars Portfolio
Insulins & Analogs
As a credible, global insulins player, we are committed to addressing the growing healthcare challenges associated with diabetes. To deliver on this commitment, we have made significant investments in developing a range of affordable basal, rapid and intermediate acting biosimilar insulins for patients worldwide. The portfolio comprises Recombinant Human Insulin (rh-Insulin), Insulin Glargine, Insulin Aspart and Insulin Lispro along with delivery devices.
Biocon has today emerged as the largest insulin producer in Asia. It is also among the Top 3 biosimilars players globally in both rh-Insulin and Insulin Glargine in terms of volume market share.
Biocon’s high quality, affordable biosimilar insulins provide cost-effective alternatives to expensive branded products, giving patients, physicians and payors a wider option of treatment choices, enhanced access to insulin and improved diabetes management.
In 2004, Biocon introduced the first indigenously developed and produced rh-Insulin, Insugen®, in India. Insugen® provided access to a safe, effective yet affordable alternative to imported insulins for people with diabetes in India and is today the largest generic insulin brand in the country. Biocon’s rh-Insulin now provides affordable access to insulin therapy for patients and partners in several countries across the world, with millions of people with diabetes benefitting from this product and living a better life. The Company is currently working on its rh-Insulin product targeted at the U.S. market.
In 2009, the company developed and launched a long-acting basal Insulin Glargine, Basalog®, for patients in India. We also worked diligently to take our Insulin Glargine to more markets across the globe. We achieved a major milestone with the approval and launch of our Insulin Glargine in Japan in 2016. Biocon’s Insulin Glargine was the first biosimilar from India to be approved in Japan and helped establish our credibility as a serious player in the biosimilars sector.
This credibility was further enhanced when Biocon, along with its partner Mylan, received approval from the European Commission in 2018 to sell Semglee™ (Insulin Glargine) in all 28 European Union (EU) member states and the European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein. Our biosimilar Insulin Glargine has also been approved in Australia, Russia, Mexico, South Korea, Malaysia and over 25 other countries.
Monoclonal Antibodies & Other Recombinant Proteins
Biocon and Mylan are co-developing a high-value portfolio of three monoclonal antibodies (Trastuzumab, Bevacizumab, Adalimumab) and three recombinant proteins (Pegfilgrastim, Etanercept, Filgrastim), targeting chronic diseases such as cancer and a range of autoimmune disorders.
We are now the first company from India to get our biosimilars for Trastuzumab and Pegfilgrastim approved by the U.S. Food and Drug Administration (FDA). We are also the first Indian company to launch a biosimilar in the U.S., through the commercialization of Fulphila™ (biosimilar Pegfilgrastim) by our partner Mylan.
We created history in December 2017 when our biosimilar Trastuzumab won approval from the U.S. FDA. Ogivri™ is the first biosimilar Trastuzumab (trastuzumabdkst) to be approved in the U.S. It defines an inflection point in Biocon’s biosimilars story as Ogivri™ is not only the first biosimilar from our joint portfolio with Mylan to get a regulatory approval from the U.S. FDA but has also made us the first Indian company to have a biosimilar approved in the U.S.
Fulphila™ is the first biosimilar Pegfilgrastim (pegfilgrastim-jmdb) to be approved by the U.S. FDA in June 2018.
The approval and launch of Fulphila™, ahead of major global biotechnology competitors, demonstrates our scientific depth, quality of the teams and our ability to execute on difficult-to-develop and manufacture, complex products like biosimilars. These developments have not only placed us in an exclusive league of global biosimilars players, but have also established us as a credible biologics player from India that can compete with the best in the world.
In keeping with our vision to make a difference by enhancing affordable access to world-class, cutting-edge biologic therapies for patients in India first, Biocon successfully launched a high quality, world-class biosimilar Bevacizumab as KRABEVA® for patients of various types of cancer in India in 2017.
KRABEVA®, prescribed for metastatic colorectal cancer (mCRC) and several other types of lung, kidney, cervical, ovarian and brain cancers, is our second oncology biosimilar in India after Trastuzumab. Our introduction of CANMAb™ in India in 2014 as the world’s first biosimilar Trastuzumab had opened the doors for the patients to access an affordable therapy, which is now the No. 1 brand of Trastuzumab in the country.
We are also the first to get regulatory approvals for biosimilar Trastuzumab in Brazil and Turkey, two of the Top 4 emerging markets globally for this key breast cancer drug.
Prepared to Make a Difference Globally
Biocon has attained a strong competitive edge in the marketplace and become one of the leading global players for biosimilars, which are expected to help reduce financial burden on healthcare systems globally, allowing them to afford and hence expand access of new advanced treatments to their patient populations. Our conviction that our success would enable us to make a very significant change in managing both chronic and acute conditions continues to push us forward.
Partnering to Win
To take our biosimilars to a global patient pool, we partnered with U.S.-based Mylan for the co-development of a high-value portfolio of biosimilars for oncology and autoimmune indications in 2009 and then expanded it to include insulin analogs in 2013. This partnership, structured as a sharing of risks and rewards, leveraged the complementary strengths of each partner and was a forerunner of many global partnerships that exist today in the biosimilar space, including those involving many innovator companies.
With one of the longest-standing partnerships in the global biosimilars space, Biocon and Mylan have achieved a leadership position in the nascent industry. By leveraging mutual strengths we have successfully built one of the largest and most diverse biosimilar pipelines.
We have also agreed to extend the Mylan partnership to include two new assets, which target opportunities that are expected to open up in the middle of next decade.
After successfully collaborating with Mylan, we have partnered with Sandoz, a Novartis division and a global player in biosimilars. This collaboration is targeted at developing a next-generation biosimilars portfolio which will help patients worldwide gain access to a range of high quality, affordable immunology and oncology biologics. Biocon and Sandoz will strategically leverage their combined strengths to address the next wave of the global biosimilars opportunities.
At the same time, we continue to work independent of these partnerships towards augmenting our portfolio with more biosimilar candidates under development.
As practitioners of frontier science, we have built a pipeline of novel biologics that can address unmet needs in diseases such as diabetes, cancer and autoimmune conditions. Our basket of novel assets under development represent an interesting combination of early and advanced stage programs. Our foray into novel biologics predates our entry into the biosimilars segment. We are the pioneers in developing, manufacturing and launching a couple of novel biologics in India, including BIOMAb-EGFR®, India’s first indigenously produced novel monoclonal antibody for the treatment of head and neck cancer. We also launched ALZUMAb™, the world’s first novel anti-CD6 monoclonal antibody, in India, for psoriasis.
Our existing novels portfolio has diverse assets acquired through early stage partnerships. These include an oral insulin molecule; monoclonal antibodies against novel targets like CD6, against established targets like CD20 and EGFR; a pipeline of bispecific fusion antibodies that exploit the recent understanding of the role of checkpoint inhibitors; and a siRNA-based molecule.
We have generated encouraging and exciting data, garnering a great deal of licensing and partnering interest. The endorsement of our approach is evidenced by the financial and scientific participation of credible organizations like JDRF (U.S.) in the development of Insulin Tregopil for people with Type 1 diabetes. Such partnering, combined with a prudent stage gate approach to development, help mitigate our financial exposure in these high risk but high reward initiatives.
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.
- 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 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.
- Type 1 diabetes mellitus
- Type 2 diabetes mellitus
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.
- Type 1 diabetes mellitus
- Type 2 diabetes mellitus
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.
- Type 1 diabetes mellitus
- Type 2 diabetes mellitus