The Biotechnology Industry Organization (BIO) thanks the European Medicines Agency (EMA) for the opportunity to submit comments on the "Guideline on Similar Biological Medicinal Products Containing Monoclonal Antibodies."
BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products, thereby expanding the boundaries of science to benefit humanity by providing better healthcare, enhanced agriculture, and a cleaner and safer environment.
The Guideline in general is useful and contributes guidance to those planning to develop biosimilar versions of existing originator monoclonal antibodies. The Guideline attempts to cover a very wide and diverse group of products, including some novel types of monoclonals not yet envisaged as potential biosimilars. For this reason it has to allow for a range of circumstance and be potentially very flexible. However, this partly limits the Guideline‟s usefulness and may leave sponsors requiring further specific scientific advice in many circumstances. It may be more appropriate to revisit the concept of having sub-class specific sections/appendices or providing additional details rather than referring to a case-by-case approach in so many places. We request that the EMA be clear with regard to informing applicants whether or not this is an overarching Guideline, to be followed by more detailed guidelines for specific mAbs, similarly to what has been done for less complex biosimilars. If more specific guidelines are not envisioned, then this one may require additional detail and boundaries in order to effect efficient development.