Table of Contents
An Addendum to “Specialty Physicians Discuss their Opinions of the United States Biosimilars Market”
•The arrival of biosimilars, or highly similar copies of biopharmaceutical products, to the US market is imminent. Although the products have been available elsewhere—including Europe—for several years, physicians and other key stakeholders in the United States have only recently begun to anticipate their arrival.
•This panel discussion was conducted to preview the thoughts and expectations of specialty physicians who would be expected to be among the first customers of biosimilars, with the objective of gaining insight into some of the major factors that could influence market uptake.
•Based on this representative sample of physicians, the overall adoption of biosimilars can be expected to experience a widespread uptake due to 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.
•Potential skepticism may be overcome with the help of convincing noninferiority clinical data for products from reputable companies that are highly experienced with biologics. Educational programs deemed to be unbiased that convey this data could help increase awareness and boost physician confidence in biosimilar products.
Frost & Sullivan assessed physicians’ willingness to prescribe biosimilars in the United States.
The objective of this research was to conduct a highly qualitative analysis of a representative sample of practicing specialty physicians in the United States in the spirit of an interactive roundtable discussion.
The primary goal was to encourage participants to freely express their opinions and ideas around all aspects of a topic, facilitating a free exchange about how biosimilars will impact their practice and the overall US healthcare market.
This research was not intended to produce quantitative data.
The biosimilar research panel consisted of preselected participants and was conducted via online moderated discussion boards over a three-day period (October 11-13, 2011). A series of questions was asked on current topics of interest to specialty physicians as well as pharmaceutical and biotechnology companies. Questions and discussions were designed to gauge both short-term and long-term trends and impacts.
The panel consisted of specialty physicians: seven oncologists, seven rheumatologists, and 6 hematologists. Panel participants were randomly selected from a pool of prescreened, qualified candidates and mainly represented hospitals and independent practices across the United States. Selection of specialty practices was based on the therapy area of those biosimilar agents anticipated to enter the US market in the foreseeable future.
Biopharmaceuticals and Biosimilars
•Biopharmaceuticals represent one of the most important innovations in medical history. However, these breakthrough therapies are extremely costly, owing to the magnitude of investment necessary in their discovery and development, driving a need for less-costly alternatives.
•While current regulations allow for the approval of generic copies of conventional pharmaceuticals at greatly reduced costs, until recently there has not been the technology nor regulatory pathway with which to introduce lower-cost versions of biologics.
•The US Congress has recently enacted legislation to enable and encourage the introduction of biosimilars/follow-on biologics, paving the way into an untapped market.
•However, many obstacles to a clear abbreviated regulatory pathway and market uptake in the US remain, such as guidance regarding clinical research requirements, naming convention, and end-user acceptance to name a few.
•While sponsors await final guidance from the Food and Drug Administration (FDA), Eli Lilly, and Boehringer Ingelheim have opted to file LY2963016, a biosimilar version of Sanofi’s Lantus (insulin glargine) through the 505(b)(2) pathway, and the application was recently accepted by the FDA in December 2013.
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