Biotech Values

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Pharmaview article - Key competitors (thx torques)
Who will be the key competitors in the biosimilars market?

Although major generics companies continue to strategize to gain a stronghold in the biosimilars market, interest is increasing among big pharma, biotech and companies in emerging markets (especially India) in competing in the biosimilar market.

Success within the biosimilars market will require a unique combination of capital investment and in-house experience, above and beyond what is expected of traditional generics manufacturers. Companies participating in the biosimilars market will face significant additional costs relating to biologics manufacturing and production, substantial clinical development programs and product sales and marketing. These challenges suggest that the top companies of tomorrow will more closely resemble biotech and specialty pharma companies than generics companies. Indeed, they may be today’s top companies—pharmaceutical giants like Pfizer have publicly announced plans to develop biosimilars and have been acquiring additional biologics know-how.

The companies poised to capture the majority of early biosimilar sales have biosimilars already marketed in the EU.

Teva has a biosimilar G-CSF approved, has numerous biosimilars marketed in non-Western countries and has a pipeline of undisclosed molecules from simple recombinant proteins to (likely) monoclonal antibodies. Teva has also been steadily investing in biologics capabilities: in 2007, it acquired CoGenesys and, in 2008, the company completed the acquisition of fellow generics giant Barr (which had acquired the biotech Pliva for its biosimilars capabilities). In the process, Teva may have created the premier biosimilar player of the moment.

Sandoz has also established itself as a major biosimilars player: it had the first biosimilar approved in the EU and the United States (Omnitrope) and another biosimilar ESP launched in the EU in 2007. Sandoz also has a pipeline of 24 undisclosed molecules in development, including complex biosimilars. With access to Novartis’ branded sales and marketing channels, and global reach, Sandoz has a distinct advantage over pure generics companies, which have to partner or invest to obtain similar capabilities.

BiogeneriX (ratiopharm), Bioceuticals (Stada), Biopartners (Bioton) and Hospira all have biosimilars marketed or approved in the EU. Of these four companies, Biopartners has the most advanced program; it has several biosimilars already marketed in Eastern Europe and other non-Western regions.

Among emerging players, United States-based Insmed is emerging as a future acquisition or partnering opportunity; it has four biosimilars in its development pipeline and strong public visibility through its U.S. lobbying efforts and educational outreach programs.

Meanwhile, Indian biotech and generics manufacturers, many of which already market biosimilars locally, are looking to the lucrative Western markets for expansion. Dr. Reddy’s currently markets a biosimilar G-CSF and a biosimilar monoclonal antibody in India (Reditux, biosimilar rituximab) and has numerous undisclosed molecules in development. Wockhardt, Biocon and Intas Biopharmaceuticals are also key players to watch; each of these companies develops and markets biosimilars in India and each recently acquired or established local partnerships in Western markets.

Conclusion

Market forces dictate that biosimilars are an increasing reality. A clear understanding of biosimilar targets (and their commercial status), the regulatory framework and key stakeholder attitudes is paramount in recognising how the market will unfold—and then in developing and implementing an effective medium-term strategy.