Recent approval of Zarxio (filgrastim-sndz) as first biosimilar by U.S. FDA has opened new opportunities for biosimilar manufactures. Patents for number of blockbuster bio-pharmaceuticals have either expired or are on the verge of expiration, which is majorly driving the growth of biosimilars industry. Changes in regulatory guidelines and convenient biosimilar drug approval processes have a major impact on the commercial growth of global biosimilars market. However, the high investment associated with research and development, longer development processes and requirements of economies of scale for profitability largely limit the growth of biosimilars market. The integration of developmental plan with regulatory guidelines and the adoption of optimal commercial strategies would play crucial role in commercial growth of biosimilars market.
Over 10 blockbuster biologics with annual sales of $60 billion are facing patent expiries in Europe and in the U.S. during the next four years. Top pharmaceutical manufacturing brands are repositioning their strategic agendas from approvals to product launches to gain market capitalization. "Biosimilars developers have been using emerging markets with less intellectual property protection as their launch pad for established markets" say AMR analysts. "With regulatory framework maturing in established markets, it will be easier for biosimilars manufacturers to quickly enter into such markets" analysts added, citing collaboration between Mylan and Biocon to commercialize biosimilar of trastuzumab in India and the approval of first biosimilar version of monoclonal antibody drug by Hospira in Europe. Due to lower intellectual property rights protection and higher activity of regional players, the Asia Pacific region has emerged as the leader in biosimilars market.
The commercialization of filgrastim biosimilars in the United States have brought the revolutionary changes in development of biosimilars. Pharmaceutical companies interested in investing into biosimilars market are now focusing on the agreement and acquisitions, in order to expand their presence in biosimilars market. Recently, the Pfizer has acquired Hospira, a global leader in biosimilars. This acquisition has strengthen the biosimilar portfolio of Pfizer. Also, it increases the global reach of Hospira through commercial capabilities, scientific expertise of Pfizer. The key companies profiled in the report are Novartis (Sandoz), Synthon Pharmaceuticals, Inc., Teva Pharmaceutical Industries Ltd., LG Life Sciences, Celltrion, Biocon, Hospira, Merck Serono (Merck Group), Biogen idec, Inc., and Genentech (Roche Group).
AMR analysis suggests that Erythropoietin biosimilars are the most promising products, anticipating substantial revenue generation from patented biologics. Granulocyte colony-stimulating factor biosimilars are following erythropoietin in terms of revenue generation during the forecast period. Biosimilars in oncology disorders are currently dominating the market due to high-priced patented drugs such as erythropoietin and monoclonal antibodies that are largely used in the oncology treatments. However, biosimilars for chronic and autoimmune diseases and blood disorders are the fastest growing applications and expecting a salutary growth during the analysis period.
The key players profiled in this report include Novartis (Sandoz), Synthon Pharmaceuticals, Inc., Teva Pharmaceutical Industries Ltd., LG Life Sciences, Celltrion, Biocon, Hospira, Merck Serono (Merck Group), Biogen idec, Inc., and Genentech (Roche Group).
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