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New Biologics Must Show Improvements in Efficacy, Safety and Cost-Benefit Compared with Currently Available Agents for Inclusion on Formularies in Argentina, Brazil and Mexico
Date:12/19/2013

BURLINGTON, Mass., Dec. 19, 2013 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that novel biologics must demonstrate improvements in efficacy, safety and cost-benefit compared with currently listed agents for a given disease to be included on both national and institutional formularies in Argentina, Brazil and Mexico. According to the new Strategic Insights report entitled Trends in Reimbursement of Biologics Across the Growth Markets: Focus on Argentina, Brazil and Mexico, numerous novel biological agents are in late-stage development for a range of oncology indications, rheumatoid arthritis and diabetes, and could reach these markets in the next two to three years.

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The report notes that the market for biologics is lucrative, and growth in this sector will outpace the overall oncology and rheumatoid arthritis drug markets, resulting in an increase share of biologics in these markets.

"While approval from the regulatory bodies of Argentina, Brazil and Mexico may be reached shortly after a drug's approval in the major pharmaceutical markets, it may precede inclusion on formularies in these markets by several years," said Decision Resources Group Analyst Natalia Reoutova, M.A., M.Sc. "Historically, authorization was sufficient for market access terms but today, it's only one step toward favorable market access."

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