Review on the Current and Future Trends of Biosimilar Market in USA and India

Review on the Current and Future trends of Biosimilar Market in USA and India

Pankaj Goel1

1Business Development Department, Stellarix Consultancy Services Pvt. Ltd., India

1 pankaj.goel@stellarix.com | (+91) 141-511-1443

1. Quick Facts on Biosimilars

1.1 Generic version of the biopharmaceutical products that have equivalent implications and efficacy are considered as Bio-similars or follow-on biologics.

1.2 Patents on the biological products expire after limited period of time which gives an opportunity to other companies to manufacture similar products and if approved by FDA or EU they can be used to treat the diseases. In other words they become the subsequent versions of the innovator product

1.3 The cost of research, production of the bio-pharmaceuticals (e.g. insulin, human growth hormone, interferons, erythropoietin etc) as well as various subsequent factors like escalating manufacturing expenditure, patent filling and its maintenance fee etc. makes them expensive.

1.4 So, once the term period of patents of these life-savers is over, the similar products can be manufactured by other companies (breaking the monopolistic market as well) and can market them by the name of Biosimilars.

2. Companies marketing Innovator product and their upcoming Biosimilars in market

Table 1: Companies marketing Innovator product and their upcoming Biosimilars in market

Company producing innovator product

Innovator Product

Biosimilars producing companies

Biosimilar Products Launched

Approval year

Pfizer

Genotropin

Sandoz

Omnitrope

2006

Eli Lilly

Humatrope

Biopartners

Valtropin

2006

Janseen- Cilag (subsidiary of J&J)

Eprex/Erypo

Sandoz

Binocrit

2007

Johnson & Johnson

Eprex

Stada

Silapo

2007

Amgen

Neupogen

Teva

Tevagrastim

2008

 

This gives the opportunity to other manufacturers to create similar biopharmaceuticals (i.e. Biosimilars) and sell them in the market. Even, the sales of Biosimilars going off patent in US has been projected to exceed to those of conventional ones. Moreover, the potential market for Biosimilars is projected to grow in next 6 years as more Biosimilars come off patent.

3. Biosimilar market in USA

The expiration of the patents protecting the pharmaceuticals has opened the door to the creation of Biosimilars. Patents for many products are about to expire in 2012 and some of them have been listed in table below.

Table 2: List of innovator products about to go off-patent in year 2012

Drug name

Company

Patent expiry date

Crestor

AstraZeneca

2012

Symbicort

AstraZeneca

2012

Lexapro

Forest Laboratories

2012

Avandia

GlaxoSmithKline

2012

Singulair

Merck

2012

Zometa

Novartis

2012

Diovan

Novartis

2012

 

This gives the opportunity to other manufacturers to create similar biopharmaceuticals (i.e. Biosimilars) and sell them in the market. Even, the sales of Biosimilars going off patent in US has been projected to exceed to those of conventional ones. Moreover, the potential market for Biosimilars is projected to grow in next 6 years as more Biosimilars come off patent.

4. Comparison between projected sales of expiring products and Biosimilars

Graph 1: Comparison between projected sales of expiring products and Biosimilars

5. Biosimilar Market in India

Response of Indian Companies also looks good with more than 10 Biotechnology companies competing in this area and more than 40 Biosimilar products available in the Indian market. Amongst current competitors, Dr.Reddy’s has many Biosimilar products to its name and also the biggest Biosimilar player in the Indian market. E.g. Reditux, the world’s first Biosimilar monoclonal antibody is registered to it as a copy version of Mabthera/ Rituxan in India and was launched at 50% less price than the originator.

Table 3: Indian Companies in Biosimilars Market

Indian Company

Biosimilar Product

Dr Reddy’s Lab

Grafeel, Reditux, Cresp

Intas

Neukine, Neupeg, Intalfa, Epofit

Shantha Biotech/Merieux Alliance

Shanferon,Shankinase,Shanpoietin

Reliance Life Sciences

ReliPoietin, ReliGrast, ReliFeron, MIRel

Wockhardt

Wepox, Wosulin

Biocon

Eripro, Biomab, Nufil, Myokinase, Insugen

 

The cost involved in the development of Biosimilars in India can be between 10-20 million USD due to legislation and environment in the country. Also Biosimilars in India need not undergo phase I/ II studies but phase III is a mandatory step and minimum 100 patients are needed for this study. Thus they can be launched at 25-40% lesser price than the originator too.

Sales figures of Indian Biosimilars in 2008 were recorded to be 200 million USD and looks promising for the upcoming years too as market for 2012 has been forecasted to 580 million USD, which means a CAGR of +30%.

6. Future of Biosimilars

Graph 2: Global revenue forecasts of Biosimilar market

Apart from India and USA, companies in many other European and Asian countries are coming up with more biosimilar products in biological market and the chances of availability of products are increasing.

This endeavour is expected to take the competitiveness amongst companies to new heights. They will have to meet the challenge of making biologically similar products which are effective and economical in order to establish themselves in the market.

It is inevitable that Biosimilars will soon have a substantial impact on the biologics market. The market research analysts reported that the revenue of biosimilars in global market was $66m in 2008 and is expected to increase to $2286m in 2015 at compound annual growth rate (CAGR) of 65.8%.

7. References

7.1 Nature

7.2 Biospectrum

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