Biosimilars outlook brighter on CHMP EPO recommendations and US Senate moves

US Senate initiatives to introduce abbreviated approval guidelines for biosimilars and recent European recommendations for the approval of three biosimilar copies of erythropeitin have dramatically improved the outlook for this type of drug copy (Marketletters passim). However, even after approval, biosimilars' market penetration will vary depending on country-specific characteristics, as highlighted in a new multi-client study from Global Insight. Recently, the US Senate made progress on biosimilars, approving legislation by addressing the key contentious issues of immunogenicity, patent protection and interchangeability.

True to its reputation as the leader in biosimilars, the European Union is on its way to issuing final approval to several copies of eoetin alfa-a class of biologics associated with a high risk of immunogenic side effects. Europe will remain a testing ground for biosimilars market success, but the level of penetration in different countries will be tempered by specific factors, in addition to the general "barriers to market entry" that apply to biosimilars everywhere.

The USA remains by far the most attractive market for makers of biosimilar drugs, but a lack of regulations will postpone significant biosimilars penetration there for the time being, the study says.