EMA Solicits Comments on Product-Specific Bioequivalence Guidelines

Agency aims for consistent biosimilar evaluation procedures, while future in US remains unknown.

The European Medicines Agency (EMA) has released its first draft of a concept paper on developing product-specific bioequivalence guidelines, and is soliciting public comments on the document.

It intends to develop a consistent method for evaluating biosimilar applications for bioequivalence that applies to all methods of application permitted by the EMA.

The EMA released its concept paper on July 25, 2013, and began its public consultation period on August 1, 2013. Its deadline for comments is September 30, 2013. The EMA anticipates developing its first set of product-specific guidances during its October 2013 Committee for Medicinal Products for Human Use meeting, and then releasing it for further public comments.

Although the EMA did not explicitly state when it would be releasing additional guidances pertaining to each biosimilar medication class, its guideline paper stated that the first set of standards developed should cover immediate-release oral medications. According to the paper, the guidance’s basis should be the Guideline on the Investigation of Bioequivalence, which details the requirements for the design, conduct, and evaluation of bioequivalence studies.

It should also address several key fields, including the medication’s position within the EMA’s Biopharmaceutical Classification Scheme and elements of any bioequivalence studies (ie, administration schedule, study participants, administration conditions, medication strength, and number of necessary studies). Additional factors the guidance should cover include the clinical components necessary for demonstrating bioequivalence and criteria for determining bioequivalence assessments, such as pharmacokinetic variables and confidence interval width.

According to the concept paper’s anticipated impact statement, product-specific bioequivalence guidelines would create a uniform and transparent process for determining bioequivalence.

George Goodno, a spokesman for Biotechnology Industry Organization (BIO), a biotechnology trade organization, said the organization was unable to comment on the EMA guidance, citing a policy against commenting on items pertaining to drug development.

Despite the approvals within the European Union, no biosimilar products have yet been approved in the United States. Relatively few companies have actively pursued biosimilar development within the US, in part because of a slowly developing pathway to market the drugs.

The FDA issued 3 guidance drafts pertaining to biosimilar products in February 2012, although the question of biosimilar “interchangeability” remains unresolved. Several states, including Florida, Illinois, California, and Texas, issued legislation creating pathways for biosimilar substitution, whereas several manufacturers, including Amgen and Genentech, have supported a bill restricting biosimilar substitution.