Fitch: Targeted Therapies Drive Record US Biologics Approvals

NEW YORK & CHICAGO--(BUSINESS WIRE)-- Link to Fitch Ratings' Report: Global Pharmaceutical R&D Pipeline (2015 - Strong Year for Approvals)

https://www.fitchratings.com/creditdesk/reports/report_frame.cfm?rpt_id=877114

The global pharmaceutical industry's increased focus on more targeted biologic therapies drove a record number of new biologic approvals during 2015, particularly in the areas of cancer, immunology and cardiology, according to Fitch Ratings.

In many cases, biologics offer innovative pharmaceutical product developers the ability to more precisely target causative factors of disease. This specificity can lead to more effective and safer treatments. We expect the industry will continue to pursue the development of biologics in addition to small molecule opportunities.

The FDA approved a record number of new biologics during 2015. Of the 12, four were cancer therapies and two were cholesterol-lowering agents. The other six received approval to treat the following: asthma, hypoparathyroidism, hypophosphatasia, lysosomal acid lipase deficiency and psoriasis. The FDA granted priority review to 6/12 (50%) of approved biologics compared with 18/39 (46%) of small molecules approved.

Innovative pharmaceutical developers made significant strides in advancing new therapies that offer clinical advantages over older therapies. However, various stakeholders are pushing back against the industry regarding costs and/or pricing. This was particularly evident with treatments for cancer, hepatitis C and high cholesterol. This tension is not new, but it has increased during the past year. The industry will increasingly need to demonstrate the value of their innovative therapies to payers.

New molecular entity approvals increased by nine last year compared with 2014. The FDA cleared 45 novel medicines for marketing during the 2015 compared with 36 in 2014. Biologics accounted for 12 (27%) of the 2015 approvals versus 10 (29%) during 2014. Of the approvals this year, more than one-half were drugs to treat cancer (33%), cardiovascular disease (17%) and infections (8%).

For more information, please see our special report titled "Global Pharmaceutical R&D Pipeline: 2015 - Strong Year for Approvals," dated February 2016, which is available on our website at www.fitchratings.com.

Additional information is available on www.fitchratings.com.

The above article originally appeared as a post on the Fitch Wire credit market commentary page. The original article can be accessed at www.fitchratings.com. All opinions expressed are those of Fitch Ratings.

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Source: Fitch Ratings

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