In recent years, the EDQM has published a series of documents on anti-TNF-alpha antibodies, a class of biologics used in the treatment of a wide range of inflammatory conditions such as rheumatoid arthritis, Crohn's disease and psoriasis. The texts include monographs for etanercept and infliximab, sold respectively as Enbrel and Remicade, and a general chapter on determining the potency of the antibodies using a cell-based assay.
Now, the EDQM has released a monograph for golimumab, another one of the five anti-TNF-alpha antagonists approved for use in the European Union. Golimumab is sold by Johnson & Johnson as Simponi. China’s Bio-Thera Solutions is working on a biosimilar copy of the J&J blockbuster.
Legally binding standard
The EDQM is accepting feedback on the draft until the end of September. Once adopted, the monograph will become a legally binding standard for golimumab products in all member states. The EDQM said it is “extremely important” that users provide feedback, adding that information shared after the adoption of text will be too late to consider.
“Users may then be in a position where their product is not compliant with the Ph. Eur. monograph, which is a legal standard in Europe. This could ultimately lead to a situation where a product can no longer be marketed in Europe,” wrote the EDQM.
The golimumab monograph is the result of the P4 Bio Procedure that the EDQM initiated in 2008 to ensure suitable public standards are in place when biologics come off patent. Through P4 Bio, EDQM seeks to work closely with the manufacturer of an on-patent biologic to elaborate monographs for products that will face biosimilar competition in years to come.
From 2014 to 2018, the EDQM implemented six monographs through the pilot phase of the procedure. Biologics addressed in the pilot phase of the initiative include insulin glargine and etanercept, the active ingredient in Amgen’s Enbrel.
The decision to create a monograph for golimumab was made in 2018, after the EDQM concluded the pilot phase and made the procedure an established mechanism for setting public standards for biotherapeutic proteins.
Ustekinumab, the active ingredient in J&J’s autoimmune drug Stelara, was added to the list of P4 Bio projects last year. Work on the ustekinumab monograph is advancing in parallel to efforts to develop biosimilar versions of the blockbuster biologic.