The Approval Of The First Biosimilar Monoclonal Antibody In Europe Has Major Implications For 2014 And Beyond New Report from Decision Resources Identifies Key Clinical, Corporate and Regulatory Events Affecting the Biosimilars Market
BURLINGTON, Mass., Dec. 5, 2013 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, identifies key clinical, corporate and regulatory events affecting the biosimilar industry and finds that 2013 was a pivotal year for biosimilars. The Strategic Insights report entitled Biosimilars in 2013: Landmark Events and What They Mean for 2014 and Beyond notes the approval of the first biosimilar monoclonal antibody in Europe—Celltrion's Remsima and Hospira's Inflectra, a biosimilar version of Merck's Remicade (infliximab)—will have major implications for 2014 and beyond.
The report finds that while biosimilars in other product classes (i.e., human growth hormone, granulocyte colony-stimulating factors and erythropoiesis-stimulating agents) have been available in Europe for several years, overall biosimilars sales remain relatively modest. The advent of the first European biosimilar monoclonal antibody heralds a new dawn in the industry. This second wave of products is expected to bring more significant commercial rewards compared with the first wave of biosimilar products.
"Multiple biosimilars companies are scrambling to follow Celltrion's lead and tap into the significant biosimilar monoclonal antibody opportunity," said Decision Resources Group Senior Director of Biosimilars Research Andrew Merron, Ph.D. "However, outside developments in the biosimilar monoclonal antibody space, multiple other events have occurred this year that will also have significant implications for the wider industry in the short term and beyond."
Other biosimilar industry events and strategies addressed in the report include:
- The implementation of carefully considered partnerships for biosimilar development
- Regulatory success in biobetter development
- Trends toward development of biosimilars in emerging markets
- How these themes will shape the competitive, dynamic and commercially lucrative biosimilars market segment
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