The world market for biosimilars and their potential in the US

Home/Reports | Posted 26/10/2009 post-comment0 Post your comment

Kalorama Information published a new report on biosimilars, World Market for Biosimilars and the Potential for US Follow-on Biologics on 1 August 2009, based on interviews in the ‘biogeneric’ drug industry and an extensive literature study.


The report provides information on the current market size and forecasts for biosimilars in Europe and the rest of the world; a review of marketed biological drugs with expired patents; a review of marketed biological drugs with active patents; profiles of the major competitors in biosimilars (Apotex, Biocon, Biogenerix, BioPartners, Cangene Corporation, Dr. Reddy’s Laboratories, Dragon Pharmaceuticals, GeneMedix, Hospira, Merck Bioventures, Microbix Biosystems, Momenta Pharmaceuticals, Phage Biotechnology, Ranbaxy Laboratories, Sandoz, STADA, Teva, and Watson); a discussion of FDA and EMEA regulatory activity; pending U.S. legislation and projections for US markets; a coverage of patent trends, pricing trends, healthcare spending, intellectual property and other relevant issues and trends.

The report focuses on the market for products that have lost patents in key markets. Projections were made based on the progress that is occurring within the generic arena in terms of capabilities, capital, interest, and development of biopharmaceuticals.

Kalorama identified biopharmaceuticals that have lost patent protection, which are likely to be the first products that will be targeted by generic companies. Some of these products are relatively simple in structure (by biotech complexity), such as the insulins and human growth hormones, while others are extremely difficult to process.

Many of these products have sales of over US$10 billion (Euros 6.78 billion), presenting a ripe opportunity for generic manufacturers. However, because many of these products demonstrate sales of over US$1 billion (Euros 678.52 million) per year, it is anticipated that there will be considerable resistance from the biotech innovator companies in allowing generic capitalisation and consequently approvals.

The information and analysis presented in this report are based on an extensive survey among senior managers in the biosimilars drug industry. Background information was obtained from a comprehensive search of published literature and reports obtained from various government, business, medical trade, and international journals. Key information from published literature was used to conduct interviews with over 42 industry executives and product managers to validate and obtain expert opinion on current and future trends in the industry. Interviews were also used to confirm and/or adjust market size, as well as in formulating market projections. The geographic scope of the study is worldwide, with particular emphasis on Europe and the US.

Online PR News 30 September 2009. World Market for Biosimilars and the Potential for US Follow-on Biologics.

Bharat Book Bureau, The World Market for Biosimilars and the Potential for US Follow-on Biologics, August 2009.

Source: Online PR News; Bharat Book Bureau; Kalorama Information

comment icon Comments (0)
Post your comment
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010