Clinical Pharmacology Data to Support a Demonstration of Biosimilarity
to a Reference Product, http:// www.
55) Unlike a showing of biosimilarity
, a showing of interchangeability permits the follow-on biologic to be substituted for the innovator biologic without consulting the prescribing healthcare provider.
Following similar idea, the biosimilarity
of biosimilar products can be assessed using the two-parameter approach by taking the possible variation into account.
First, the BPCIA itself defined biosimilarity
to mean "the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components," and that "there are no clinically meaningful differences between the [biosimilar] biological product and the reference product in terms of the safety, purity, and potency of the product" [emphasis added].
This edition has been updated to include new findings in drug delivery and dosage form design and revised worldwide regulatory requirements, as well as new topics like the history of generic pharmaceuticals, new guidelines for submissions related to bioequivalency studies, models of noninferiority, the biosimilarity
of large molecule drugs, the bioequivalence of complementary and alternative medicines, biosimilar therapeutic proteins and monoclonal antibodies, new FDA guidelines for bioanalytical method validation, outsourcing and monitoring bioequivalence studies, and the future of the field.
His topics include bioequivalence experience for small-molecule drug products, statistical methods for assessing average biosimilarity
, non-inferiority versus equivalence/similarity, issues on immunogenicity studies, stability analysis of biosimilar products, and assessing biosimilarity
using biomarker data.
This protein has all the criteria as a good candidate for biopharmaceutical interest since it demonstrates biosimilarity
to Forteo, one of the well defined biopharmaceutical proteins which is available in the market.
Under their amendment, the competent authorities would not have to re-evaluate the essential elements, such as the bioequivalence of generics or the biosimilarity
of biosimilar medicines.
The key of the three documents is titled "Scientific Considerations in Demonstrating Biosimilarity
to a Reference Product," and establishes the three categories of information the FDA will require: physical/structural analyses, animal testing and clinical studies.
At the core of biosimilarity
is the initial need to define and establish structural similarity for therapeutic proteins using appropriate analytical techniques.
The ruling was based on questions concerning CMC (Characterization, Manufacturing and Control) and biosimilarity
that have not yet been resolved to the extent the CHMP believes necessary for a biosimilar.
Read BIO's comments on Scientific Considerations in Demonstrating Biosimilarity
to a Reference Product: www.