Chemically synthesized proteins referencing biological medicinal products

A EuropaBio white paper

The current situation

Some proteins can be produced either by using a biological manufacturing process or through chemical synthesis.
After loss of exclusivity follow-on products could use one of the two manufacturing principles and, in EU, both chemically synthesized and biologically produced follow-ons are allowed to reference a biological originator.

EMA classifies a follow-on product as a small molecule or as a biological medicinal product  based on its own manufacturing process, rather than that of its reference product. This classification determines the available legal basis to be used for registration. Thus, today follow-ons produced by different methods will be classified differently, as biosimilars, hybrids or generics, even though they all reference the same biological original, and all are present on the entire, or parts of the EU market, simultaneously.

The problem

Follow-on products that have been classified differently have differing requirements for documentation, prescribing, dispensing and adverse event reporting despite referencing the same product and despite being present on the EU market simultaneously.

To address this, we suggest that all follow-on products to biological medicinal products be treated in a consistent manner following biosimilar principles for the review and registration in EU.

EuropaBio call for action

EuropaBio would welcome a dialogue with the European stakeholders on the best way of ensuring equal and transparent measures for assessment, traceability, adverse event reporting, prescribing and dispensing for all follow-ons of a biologic originator.

EuropaBio would also welcome a guideline for chemically synthesized proteins.