SOURCE: Frost & Sullivan

Frost & Sullivan

December 14, 2011 08:00 ET

Frost & Sullivan: Specialty Physicians Are Poised to Embrace Biosimilars Arriving Imminently to the U.S. Market

The Food & Drug Administration Is Scheduled to Release Guidelines for the Approval of Biosimilars by the End of 2011

MOUNTAIN VIEW, CA--(Marketwire - Dec 14, 2011) - The U.S. biosimilars market is a fast approaching reality. For example, the Patient Protection and Affordable Care Act of 2010, better known as the healthcare reform introduced by President Barack Obama, includes a provision for the establishment of a Food & Drug Administration (FDA) approval pathway for biosimilars. However, much uncertainty lies ahead, including the market potential as a function of physician adoption of biosimilars, as well as the fact that Amgen's new Enbrel patent could delay a biosimilar version for 17 years.

New analysis from Frost & Sullivan's ( Specialty Physicians Discuss their Opinions of the United States Biosimilars Market research includes an overview of a panel discussion with specialty physicians who are expected to be among the first users of biosimilars in the U.S. This research previews the thoughts and expectations of practitioners to gain insight into some of the major factors which could influence market uptake.

If you are interested in more information on this research, please send an email to Britni Myers, Corporate Communications, at, with your full name, company name, title, telephone number, company email address, company Web site, city, state and country.

"Based on this representative sample of physicians, the overall adoption of biosimilars can be expected to experience widespread uptake," said Frost & Sullivan Industry Manager Jennifer Brice. "This is in light of anticipated access to comparable therapeutic options at a lower cost versus high-cost biologics."

Main factors with the potential to influence the rate and extent of uptake include cost, safety and efficacy data (including testing in specific patient populations), and reputation of the manufacturer. Biosimilars produced by companies that lack experience in developing and manufacturing biologics may be met with skepticism as opposed to companies with experience and a strong track record in the biologics sector.

"Physicians generally agreed that those companies with a solid reputation and strong track record of producing high-quality products would likely be trusted to bring a quality biosimilar product to market, regardless of geographic location," said Frost & Sullivan Senior Industry Analyst Debbie Toscano. "Experience with biologics, as opposed to experience with generics, is key. However, many physicians will likely be skeptical of companies based in developing countries such as India or China that lack a strong reputation due to negative past experiences."

Patients may perceive biologics, as opposed to biosimilars, as superior products simply due to their cost, as many people associate price with quality. A clear explanation of the financial advantages of developing a biosimilar, coupled with strong clinical data to support non-inferiority, may help to improve any negative perceptions of biosimilars. This positive clinical data from well-designed clinical trials may also increase the confidence level of physicians and help alleviate the concern of being forced to prescribe an inferior product. Strong clinical data will be the main driver of initial practitioner acceptance of biosimilars and biobetters.

"Potential skepticism may be overcome with the help of convincing clinical data for products from reputable companies highly experienced with biologics," said Brice. "As positive real-world experience is gained, uptake is expected to gradually increase."

Specialty Physicians Discuss their Opinions of the United States Biosimilars Market is part of the Pharmaceuticals & Biotechnology subscription, which also includes research in the following markets: Biosimilars and Follow-On Biologics Americas Conference: The Frost & Sullivan Perspective; Biosimilars -- An Emerging Market in Europe; Strategic Analysis of the Indian Biosimilar Market; and Biobetters -- Advent of a New Concept. Research included in subscriptions provides detailed market opportunities and industry trends evaluated following extensive interviews with market participants.

About Frost & Sullivan
Frost & Sullivan, the Growth Partnership Company, enables clients to accelerate growth and achieve best-in-class positions in growth, innovation and leadership. The company's Growth Partnership Service provides the CEO and the CEO's Growth Team with disciplined research and best-practice models to drive the generation, evaluation, and implementation of powerful growth strategies. Frost & Sullivan leverages 50 years of experience in partnering with Global 1000 companies, emerging businesses and the investment community from more than 40 offices on six continents. To join our Growth Partnership, please visit

Specialty Physicians Discuss their Opinions of the United States Biosimilars Market

Contact Information