Fitch: Biologics Grab Larger Share of Drug Development

NEW YORK--(BUSINESS WIRE)-- FDA approvals for biologics accounted for 28% of all new drug approvals in the last 21 months, up from 17% over the 2010-13 period, according to Fitch Ratings' latest Global Pharmaceutical R&D Pipeline report.

"Biologics will continue to take a larger share of new drug development in the next few years, although their impact on sponsor companies remains uncertain," said Robert Kirby, Director.

Since August 2015, two biologics to address high cholesterol have been approved, Repatha (Amgen) and Praluent (Sanofi), marking biologics' entrance into the cardiovascular market. As with other drugs approved for hard-to-treat patients, debates about their pricing continue.

Fitch believes the FDA will continue to focus on priority drug reviews for drugs that satisfy unmet medical needs. The number of new molecular entities approved by the FDA in the first nine months of 2015 decreased by four relative to the same period last year.

Fitch's Global Pharmaceutical R&D Pipeline report examines the research and development activities of 13 global pharmaceutical companies in Fitch's portfolio.

The full report, 'Global Pharmaceutical R&D Pipeline: Insights on Approvals,' is available at www.fitchratings.com.

Additional information is available on www.fitchratings.com

Global Pharmaceutical R&D Pipeline (Insights on Approvals)

https://www.fitchratings.com/creditdesk/reports/report_frame.cfm?rpt_id=874200

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View source version on businesswire.com: http://www.businesswire.com/news/home/20151204005524/en/

Fitch Ratings
Bob Kirby, CFA
Director
+1-312-368-3147
[email protected]
Fitch Ratings, Inc.
70 W. Madison St.
Chicago, IL 60602
or
Media Relations
Alyssa Castelli, +1-212-908-0540
[email protected]

Source: Fitch Ratings

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