Biosimilars: Advancements, Future and the Role of Indian Pharma Market

Dr. Piyush Gupta
Associate Director
GNH India

Biosimilars is a fairly new area in pharma as the guidelines and procedures are yet to be set by FDA. Since, they are prepared with the help of living cells, just like biologics, it becomes important to understand the composition and if it is suited for the stated ailment.

Biologics are drugs regulated by the Food and Drug Administration (FDA) used to treat chronic diseases. These are large molecule drugs and made up of living cells which make them unique and more complex than a chemically synthesized drug that is made up of small molecules. Due to the complexity of large molecules, characterization of biologics becomes difficult. Slight differences in these products are normal and are accepted by the FDA within certain limits however, it becomes important to maintain and control within -product variations so as to maintain the right amount of active ingredients in the drug.

In order to reach a larger base of patients that need biologics, their identical copies are manufactured with similar bioactivity and structure. These drugs are called biosimilars. These are drugs that are highly similar to biologics in function and structure in addition to being inter-changeable with a FDA- approved biological product. High-end technological support is needed to compare characteristics of a reference product and a biosimilar that includes chemical identity, bioactivity and structure.

The existence of an alternative pathway paves way for providing more treatment options, extended access to important lifesaving medicines and fundamentally lower costs as a result of increased possibilities in front of pharmaceutical companies. Biosimilars are at a nascent stage today with an estimated market size of $2.2 billion out of the total $32 billion Indian pharma market.

It is a fairly new area in pharma as the guidelines and procedures are not set by the FDA for biosimilars. Since, they are prepared with the help of living cells, just like biologics, it becomes important to understand the composition and if it is suited for the stated ailment. A biological product might be different than a biosimilar in terms of application as the suitability matters for the patients. Hence, biosimilars when developed are clinically tested to test the suitability for a particular patient in question.

Role of Biosimilars
Biological products are very complex in nature as they are produced in a living environment that could be yeast, bacteria or a cell. These products have transformed treatment methods for various serious diseases including cancer, dermatological conditions, rheumatoid arthritis, etc. In developing a biological product, vast amount of research and innovation is essential for the end-product. To solve this, biosimilar can play an important role. Generic drugs are copies of small molecule drugs whereas biosimilars can be similar to or sometimes interchangeable with an FDA approved biological product.

They provide the following advantages in the long run:

  • More treatment options
  • Increased access to medication to save lives
  • Economies of scale
FDA's Abbreviated Pathway
Biosimilars are safe and effective, approved by the FDA and cost-competitive . Biosimilars could provide enormous savings to consumers through more product competition. Inherent variability in case of biosimilars can exist because of their biological nature. The molecules are bigger than that of a chemically synthesized product. Biological products did not have an abbreviated approval pathway that made it difficult for them to be manufactured at low costs as the requirement was of a full data package. This gets reflected in the cost of these products in the marketplace. Data packages between a biosimilar product and the originator product are different and that is where abbreviated approval pathway comes into picture .

Steps to ensure usefulness of a Biosimilar
A biosimilar has to be highly similar with no clinically meaningful differences as compared to a reference product in terms of structure and functions. Following are the two steps that a biosimilar goes through in the tests against reference or originator drug.

1st Step:Analytical comparison for structural and functional usages-The biosimilar should have the same primary sequence and quaternary and tertiary structure that assists the functions.

2nd Step:To see for no clinically meaningful differences - Pharmacokinetics - Exposure in the body, release of drug in the body, its circulation in the body, if the transit is similar to that of the reference drug.

Safety profile of the drug also needs to be monitored to ensure it has the same profile between the products. Hence, conclusively it is determined if the product is safe and effective and it will work the same way in the body whether it's a biosimilar or a reference product. It also needs to be ensured that the same clinical result is achieved in any given patient; the application needs to include data or information that supports this. Also, medication given more than once and the impact of switching back and forth between the interchangeable products is evaluated with the switching study .

Indian Pharma market
Indian pharma market holds a prominent position in the global market scenario dominating branded generics and making up around 80% of the retail market, according to a report by Mckinsey. Due to the intense competition present in this industry, the price levels tend to be low making it further favorable to the patients. The pharmaceutical industry in India ranks 3rd in the world in terms of volume and 10th in terms of value. The industry has given rise to numerous innovations in products, infrastructure and processes . India's indigenous manufacturing methods have paved way for the development of another set of generics, this time biogenerics or biosimilars .

According to an Assocham report in 2017, the domestic biosimilars market is expected to reach $40 billion by 2030. With a CAGR of approximately 30%, biosimilars are slated to become popular very soon, as the more affordable version of biologics. Development of a biosimilar might take approximately 5 -9 years to be fully developed with a cost that is only 1/26th the cost of developing a biologic. Hence, it has the potential of providing treatment options at a significantly lower cost.

Open Market Sourcing for clinical trials
Open Market Sourcing for clinical trials Biosimilars face stringent clinical timelines and it becomes important for companies to fast-track the development process of a biosimilar for a release that is well before the market gets crowded. Open market sourcing is considered as an effective strategy to support the growth of the biosimilars market. Open market strategy proves beneficial to the biosimilar makers as the clinical trial data can be kept discreet. In addition to this, the biologics are made available at shorter lead times due to the availability of stock with the wholesaler or at a known manufacturing site.

Further, to support these clinical trials, a greater emphasis needs to be given in choosing the appropriate Comparator Sourcing Organization (CSO). The requirements range from the ability to source and transport products worldwide to validated storage/shipping systems. GNH India is an organization with industry experience of over 12 years in comparator sourcing with exports to close to 180 countries around the world. Their validated shipping and storage shipments account for more than 135,000 products in their portfolio that present a great opportunity domestically in front of the market.

Future of Biosimilars in the Indian pharma market
With the rising acceptance of this biogeneric, it is fast gaining popularity among pharmaceutical companies in India and abroad. The guidelines and procedures are moving towards providing biosimilars with the status that the industry has been waiting to attain. Adding to the catalysts is the recent USFDA approvals to various pharmaceutical organizations like Pfizer, Biocon, etc. With these progressions, the industry is fast striding forward. Biosimilars are drugs aimed at the treatment of serious and life-threatening diseases.

The Indian pharma companies are focusing all their efforts in developing their portfolio in this segment with the country's large pharma players investing in huge numbers for the Research and Development of Biosimilars. As patents of many biologics are expiring in the next few years, this aspect presents a great opportunity for the companies in India to focus their resources on the development of biosimilars.

India has a robust pipeline for biosimilar drugs that is in line with the Indian government's plans to offer grants to Indian biosimilar manufacturers . According to Decision Resources Group's analysis, more than 40 biosimilars are in the clinical development phase in India; a number higher than that in the US and almost similar to those in development in the European Economic Area (EEA). Another trick of the trade lies in strategic partnerships with companies outside of the Indian market to uplift their profiles in the world markets. Differential pricing strategies present another set of opportunity in market expansion. This could work by targeting different economical sections of consumers with differentiated pricing strategies.