Glossary & FAQs

We work closely with several companies who are authorized to source reference medicinal product (RMP) in the marketplace and can provide you with their details.  It is critical from a regulatory perspective that the comparator molecule can be fully traced and authenticated.

The biosimilar testing guidelines state that at least 6-10 batches of your biosimilar should be compared to at least 6-10 batches of innovator product. This may be done over multiple comparability studies. Any fewer batches than this and it is difficult to make any statistical claims of biosimiliarity. Further information on designing your comparability study plan can be found here.

This is the question everyone asks! It is clear from regulatory guidelines that the primary protein structure (i.e. the amino-acid sequence) must be the same. However, it is anticipated that minor differences in post-translational forms or product-related impurities will exist. These differences should be investigated thoroughly during biosimilar testing with regard to their potential impact on safety and efficacy. The US FDA states that analytical characterization should show that the biosimilar is “highly similar to the reference product notwithstanding minor differences in clinically inactive components”.

The data from protein characterization studies are used to make crucial development decisions based on a thorough understanding of the structural attributes of a biopharmaceutical. For this reason, characterization or comparability studies are not performed to GMP, since they are not testing the product against a set specification. Characterization reports are supportive to a regulatory submission and therefore developers want to be confident that the data has been generated using scientifically sound protein characterization methods. Methods and instruments should be qualified and a meaningful and well-designed quality system should be implemented and followed. Standard Operating Procedures (SOP) should be in place and should be regularly monitored and updated.

Biosimilar development and approval rely heavily on data obtained from structural characterization and comparability studies performed firstly on batches of the reference medicine and subsequently in head-to-head comparisons against batches of the biosimilar candidates. Biosimilar testing will assess the structural, physicochemical, biophysical and functional properties of the molecules.