Biosimilars 2.0

Bioanalytical strategy used in development of pharmacokinetic (PK) methods that support biosimilar programs

“…As a result the biosimilar manufacturer must demonstrate that the molecules are similar at the physiochemical and structural level, and must also conduct clinical studies to demonstrate that there are no effects on safety or efficacy as a result of analytically characterized differences that may be observed between the biosimilar and the reference product. 2,3,21,25 Product development plans for biosimilars within Amgen align with regulatory expectations by providing a comprehensive comparative data package from studies designed to thoroughly characterize the biosimilar and reference products with regards to their safety, purity and potency profiles. The plans include extensive analytical testing of the biosimilar and the reference product, often include a nonclinical toxicology study, and clinical studies that begin with a pharmacokinetic (PK) similarity study of the product(s), followed by a comparative clinical study to evaluate product safety and efficacy in the patient population.…”

The advent of biosimilars: challenges and risks

“…This is not surprising, given the knowledge gap that exists between the manufacturing of the originator product and the biosimilar. Despite these requirements, some of the biosimilars approved in the EU have exhibited different physical, chemical or immunogenicity profiles compared to their innovator products [22]. Examples were seen in a biosimilar filgrastim, which showed unexpected differences in exposure, and a biosimilar epoetin, which showed differences in titrated dosing [23].…”

“…However, for these two biosimilars, regulatory authorities ruled that these differences would not affect the overall safety or efficacy of the products. Nevertheless, the unexpected clinical findings in molecules that are supposed to be copies of the originators highlight an important point: clinical studies are a critical aspect of biosimilar development and evaluation, and are important for detecting clinical differences between structurally related molecules [22].…”

Are biosimilars the next tool to guarantee cost-containment for pharmaceutical expenditures?

“…While these findings provide the most recent estimates on biosimilar-related savings, they rely on heavy assumptions concerning outcomes of the German generic pharmaceutical market (extrapolated to other countries) and to large savings obtained within the monoclonal antibodies class (mAbs) for which biosimilars are not yet available on the market. For many countries, the hypothesis used by the authors can overestimate biosimilar-related savings as (1) the Germany generic market is more developed than that of other countries (and therefore overestimating uptake) and (2) for complex molecules (such as mAbs) it is not know whether biosimilars will enter the market immediately after that the originator patent expires [ 25 ].…”