The Food and Drug Administration (FDA) recently conducted a two-day hearing to begin the process of determining how it will go about creating review standards for the generic copies (biosimilars) of prescription drugs developed from biological materials (biologics). The health care reform legislation signed into law by President Barack Obama (D) directed FDA to establish a biosimilar approval process while also creating 12 years of patent exclusivity for original biologics. The agency will accept additional public comments until December 31, 2010.

According to news sources, stakeholder viewpoints generally divided along cost, safety and ethics lines. Those companies and industries already in the generics market supported the least amount of clinical support for biosimilar safety and efficacy; they favored extrapolating the safety and efficacy data of a given biologic from one indication to another. Brand-name companies, with patent protection for original drugs and the capacity to produce their own generics, called for more extensive testing. They reportedly contended that extrapolation could present risks and that new clinical trials would be required to assess whether a biosimilar would have the same effect across varying diseases and patient populations.

Those representing the patient perspective apparently expressed concerns over the already high cost of biologics and suggested that a streamlined biosimilar approval process would help those consumers who are cutting their doses in half or avoiding treatment altogether due to skyrocketing costs. Some witnesses were apparently skeptical that an abbreviated review process would make biosimilars less expensive, noting the difficulty in replicating biologics. It was reportedly suggested that drugmakers will likely avoid the biosimilar route to approval and submit an application for a branded biologic to secure 12 years of patent protection and higher prices.

The witnesses also sparred over naming copycat versions of biologics. Pharmacists suggested giving biosimilars unique names, while generic biologic companies called for using the same name to avoid patient confusion.

Some hearing witnesses reportedly discussed the European experience with biosimilars, noting that it established an approval pathway for them in 2005. Europe follows the “similar biological medicinal products” approach, under which a product will be considered a biosimilar if it demonstrates similarity to a reference innovator biologic, as well as comparable safety and efficacy. According to one witness, about half the biosimilars developed in Europe have had unexpected clinical outcomes in their development, pointing out the need for clinical trials.

Meanwhile, U.S. Senator Bernard Sanders (I-Vt.) submitted a letter to FDA Commissioner Margaret Hamburg claiming that the new law on biologics and biosimilars is flawed because it “legislatively mandates that an applicant for marketing approval violate the ethical standards set out in . . . Article 20 of the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects.”

According to Sanders, who has thus far been unsuccessful in amending the law, the Helsinki Declaration forbids clinical trials when “conclusive proof of positive and beneficial results” already exists. Sanders contends that the 12-year period of data exclusivity provided by the new law “would prevent an applicant for [FDA] marketing approval of a biosimilar or bioequivalent product from relying on existing data establishing the safety and efficacy of the product.” He argues that repeating clinical trials is not only unethical, but a waste of existing taxpayer-funded clinical trial data. See MedPage Today, Product Liability Law 360, November 2, 2010; The (Delaware) News Journal, November 3, 2010; BNA Life Sciences Law & Industry Report, November 5, 2010.