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Indian Biosimilars Market

October 13, 2011 8:55 AM

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India is one of the biggest sources of generic industry and is one of the emerging markets with its high population and investment in technology. Although India does not have stringent regulations, the country has a big potential for biosimilars… 

If we have a look at the sales figures of Indian biosimilars, 200 million US dollars of sales was recorded in 2008. But according to the analysts, the market will grow to 580 mUSD in 2012, which means a CAGR +30%.

REGISTRATION OF BIOSIMILARS
As described, India is a semi-regulated market and no phase I/II studies are required for biosimilars. To conduct a phase III study is a mandatory step and minimum 100 patients are needed for this study.

Due to the legislation and the environment in the country, the development of a biosimilar can be between 10-20 mUSD in India, much cheaper than the fully regulated countries. And with this regard, the price of a biosimilar, can be 25-40% cheaper than the originator.

MARKET ENVIRONMENT 
Although none of the products can be considered as “true biosimilars“, there are more than 40 biosimilar products in Indian market. 15 epoetin, 8 G-CSF and 4 insulin so-called “biosimilars” are on the market and more than 10 companies are competing in this area.

Reditux, the world’s first biosimilar monoclonal antibody is a special initiative; it is registered as a copy version of Mabthera/Rituxan in India.

The anti CD20 monoclonal antibody was developed by Dr.Reddy’s and is launched with a price of approximately 50% less than the originator. Both Mabthera and Reditux have the same indications; they are used for certain lympohomas, leukemias and rheumatoid arthritis and after the launch of Reditux, the company seeked for approvals in other semi-regulated countries like Peru.

Dr.Reddy’s, the biggest biosimilars player in the Indian market, has several other biosimilars some of which are already approved and on the market:

Product name Original product Originator company Comments
Grafeel (filgrastim) Neupogen Amgen Approved in 2001 and sold in 7 countries
Reditux (rituximab) Mabthera/
Rituxan		 Roche/
Genentech		 Approved in 2007, sold in 7 countries and seeking approval in several others
Cresp
(darbepoetin alfa)		 Aranesp Amgen Launched in 2010 and the only darbepoetin alfa in India
Peg-grafeel (pelfilgrastim) Neulasta Amgen Launched in 2011 and is the only single source pegfilgrastim in the world

 

Reference: Sandhu G., Biosimilars: A strategic approach towards development and production requirements ; Generics and Biosimilars Strategies EMEA Conference; 2011 Sept 28; Istanbul, Turkey.
Source: www.drreddys.com

9 Comments

  • Arvind Kushwaha
    February 12, 2012
    4:09 AM

    The information about pegfilgrastim is not true. Intas Biopharmaceuticals was first to launch it (2007) and still captures more than half of indian market.

    Reply
  • Biosimilar News
    February 12, 2012
    2:09 PM

    It’s not mentioned as the “first pegfilgrastim” in India. Peg-grafeel is the only “single source pegfilgrastim” according to Dr.Reddy’s. Therefore, we are sorry to say this but there are no wrong information in this post.
    Thanks for your comment but we can not have the possibility to evaluate all products in the Indian market as they are not real “biosimilars”. As we all know, none of these products are developed according to the EU or WHO biosimilar guidelines, yet.
    Thanks once again,
    BSN

    Reply
    • Arvind Kushwaha
      February 12, 2012
      3:13 PM

      I beg to differ again. Intas has been approved by EMEA for filgrastim and as per their approval Clinical trials has been performed and Europe and has been successful.I also know other companies and products being approved by EMEA. Its complete wrong to say that “none of these products are developed according to the EU”.

      Secondly, can you explain what is single source pegfilgrastim? There is no word like this in technical arena. You should scrutinise the claims made by companies.

      Reply
      • Biosimilar News
        February 13, 2012
        9:31 AM

        We completely think different about the current situation. India does not have any stringent biosimilar guidelines which refer to the EMA or WHO. Therefore without getting the offical declaration from the companies or regulatory bodies, we can not say that Intas or any other companies have products which are developed according to the global biosimilar guidelines. As we all know, most of the Indian companies have different sites/processes for semi- and non-regulated markets.
        When any of these biologics are approved in the EU or US as a biosimilar, we sure can change our opinion but for the time being, neither Intas, nor Dr.Reddy’s do not have any biosimilars in the regulated markets.

        And for the claim: we are not responsible for the claims which we get from the companies. We just try not to give “wrong or misleading” information here. This post is written with a reference but we would also be pleased to get more information about Intas and any other Indian companies. If you can share your knowledge with us, it would be appreciated…
        Thanks once again for your comments.

        Reply
        • Arvind Kushwaha
          February 13, 2012
          11:36 AM

          It shall be more appropriate that someone from your team reads about indian biosimilar market and then write for this website. Also, one should read the biosimilar guidelines before publishing such a misleading line “Although none of the products can be considered as “true biosimilars”..” Thanks.

          Reply
          • Biosimilar News
            February 15, 2012
            7:56 AM

            We again think different and don’t think that there are wrong claims in our post but thanks for your valuable comments.
            We appreciate all.

  • Yamak Mehta
    June 7, 2014
    5:45 AM

    I like your articles many times and share also to my group but this time ,
    I agree with Mr. Arvind Kushwaha.

    You are just presenting Dr.Reddy’s products here that is a part of indian biosimilar market but not complete biosimilar market.

    Intas is only the first indian company , has launched 7 products in india. you can find that in below link.

    Source : http://www.intaspharma.com/index.php&option=com_content&view=article&id=95&Itemid=83

    Biocon has a very good products in market like Alzumab , Insuline , GCSF , EPO , Mabs and etc.

    Source : http://www.biocon.com/biocon_products_bio_biological.asp&subLink=bio

    same like above companies , Reliance , Shantha , Hospira, Lupin , Zydus , Cadila , Emcure , genova , SPARC , wockhardt , Cipla etc.

    http://www.nature.com/nbt/journal/v28/n9/fig_tab/nbt0910-883a_T1.html

    So please consider this in your next part of indian biosimilar market article and I am happy to share if you need any more information related to commercially available products of indian biosimilar companies.

    Reply
  • VITHALRAO KULKARNI
    July 18, 2014
    7:33 AM

    sir,
    I am suffering with acute pain of Rheumatoid Arthritis and depend on Remicade Injection but it is very very expensive( Taking at Hyd’bad India) I am waiting for other bisimilars coming to market(TNF Blocker)I heard that during this year following biologic medicines are getting realese around globe..
    1)BOW 015 FROM EPIRUS
    2) REMSIMA FROM CELLTRION
    is any latest update whether they(Infliximab) are aviable in india if so then when,Price etc
    I need help from Experts..
    VITHALRAO KULKARNI

    Reply

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