Government Regulations Propelling Biosimilars in US

Thursday 20 December 2012, Amsterdam

The regulatory environment in the US for biosimilars is very new and the country is taking a renowned interest in reforming and clearly stating the industry’s regulatory guidelines. At the end of March 2010, the United States enacted the Biologics Price Competition and Innovation Act (BPCIA), thereby creating a legislative pathway for biosimilars and follow-on biologics. The Act is enacted to increase a patient's access to expensive biologics, and it is also expected to aid reduction of healthcare costs. The approval of biosimilars will generally require submission of preclinical and clinical data that go well beyond bioequivalence studies required for generic drug products.

The 140-page report, "Global Biosimilars Market Forecast to 2015", states that biosimilars have gained significant acceptance and growth and will to continue this trend primarily due to the patent expirations of key biologics. Amongst the plethora of products, monoclonal antibodies (mAbs) are one of the largest and fastest growing segments. Oncology biosimilars have tremendous scope in the future, primarily due to their significant cost benefits over expensive branded biologics. The biosimilars market is in the nascent stage of the industry lifecycle and with around 40% of the biologic sales to be off-patent by 2015 and continued technological advancement, biosimilars represent a huge opportunity area for companies.

The study provides an extensive research and in-depth analysis of the current size and future outlook of the global biosimilars market. It includes the market analysis, key market segments, and geographical segmentation. Various types of biosimilars, such as erythropoietin, human growth hormone, G-CSF, monoclonal antibody, human insulin, and interferons have been analyzed in depth in the report. The biosimilars industry is highly varied in regulated and unregulated markets, and some of the key geographies in this regard have been analyzed. The study also analyzes the opportunities for companies in the market, in terms of key sub-segments and therapeutic areas. Overall, the research report aims at providing a balanced outlook on the market potentials.