August 5, 2013 / 8:48 PM / 4 years ago

Fitch: Biosimilar Developers Forging Ahead

(The following statement was released by the rating agency) CHICAGO, August 05 (Fitch) The foundations of the biosimilar drug market continue to take shape as drugmakers move forward with their varied and evolving strategies for biosimilar pharmaceutical development, according to a new Fitch Ratings report. The opportunities afforded by the nascent biosimilars market are significant as eight of the 20 best-selling pharmaceutical products in the world are biologics set to lose patent protection by 2020. Fitch expects the market for biosimilars to accelerate rapidly, particularly once the first of these products are launched in the U.S. -- likely in 2015. To date, few firms have demonstrated that they have sufficient financial resources, risk tolerance, and unique capabilities necessary to develop and commercialize biosimilars on their own. Consequently, many firms have partnered in their development of biosimilar drug development in order to share costs, mitigate risk, and leverage core competencies. Fitch expects most firms to continue the strategy of developing biosimilars within the context of corporate partnerships, at least through the early stages of the market's formation. Fitch expects market dynamics to materially benefit the first companies to successfully launch a biosimilar for a particular reference drug. Biosimilar drug products could conceivably capture 20%-40% of the market at a price only 20%-30% less than that of a particular reference drug. These figures compare to a near-100% market share gain and pricing discount of 70%-90% for traditional small molecule generics. However, first movers will bear costs and risks on behalf of all future biosimilar developers, including fleshing out the untested application process, educating physicians and payors, and resolving potential patent litigation. The full report, 'Trekking the Path to Biosimilars - Forging Ahead' is available at 'www.fitchratings.com'. This is the third in a series of reports dedicated to the burgeoning global biosimilars market. Contact: Jacob Bostwick, CPA Associate Director +1-312-368-3169 Fitch Ratings, Inc. 70 W. Madison Street Chicago, IL 60602 Bob Kirby, CFA Director +1-312-368-3147 Media Relations: Brian Bertsch, New York, Tel: +1 212-908-0549, Email: brian.bertsch@fitchratings.com. Additional information is available at 'www.fitchratings.com'. Applicable Criteria and Related Research: Trekking the Path to Biosimilars -- Forging Ahead here ALL FITCH CREDIT RATINGS ARE SUBJECT TO CERTAIN LIMITATIONS AND DISCLAIMERS. PLEASE READ THESE LIMITATIONS AND DISCLAIMERS BY FOLLOWING THIS LINK: here. IN ADDITION, RATING DEFINITIONS AND THE TERMS OF USE OF SUCH RATINGS ARE AVAILABLE ON THE AGENCY'S PUBLIC WEBSITE 'WWW.FITCHRATINGS.COM'. PUBLISHED RATINGS, CRITERIA AND METHODOLOGIES ARE AVAILABLE FROM THIS SITE AT ALL TIMES. FITCH'S CODE OF CONDUCT, CONFIDENTIALITY, CONFLICTS OF INTEREST, AFFILIATE FIREWALL, COMPLIANCE AND OTHER RELEVANT POLICIES AND PROCEDURES ARE ALSO AVAILABLE FROM THE 'CODE OF CONDUCT' SECTION OF THIS SITE. FITCH MAY HAVE PROVIDED ANOTHER PERMISSIBLE SERVICE TO THE RATED ENTITY OR ITS RELATED THIRD PARTIES. DETAILS OF THIS SERVICE FOR RATINGS FOR WHICH THE LEAD ANALYST IS BASED IN AN EU-REGISTERED ENTITY CAN BE FOUND ON THE ENTITY SUMMARY PAGE FOR THIS ISSUER ON THE FITCH WEBSITE.

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