What are biomimics, you might ask. I did the same thing. Well, with the proliferation of biosimilars, we should be able to tell the one from the other.
Dr.Martínez (@MtzReuma) already has tweeted about a year ago: “… Biosimilars are NOT "biomimics" (AKA intended copies) …” (https://twitter.com/mtzreuma/status/569270634057871360). I won’t leave you with this statement though it already tells you what biomimcs are, but I’ll try to go a little deeper in the subject. “Biomimics, also known as intended copies, are non-originator biologicals that have received marketing approval before biosimilar regulations were put in place. They are currently available in some Asian and Latin American countries.” Link: http://www.gabionline.net/layout/set/print/Biosimilars/Research/Approval-of-biosimilars-in-rheumatology.
Yisaipu (益赛普) is an etanercept biomimic from China which is also sold as Etanar/Etart/Etacept in Colombia, Mexico, and India. Yisaipu wasn’t compared to innovator Etanercept. Infinitam is another etanercept biomimic, manufactured and marketed by Probiomed, a Mexican company.
Reditux® is biomimic marketed by Dr Reddy's Laboratories in Bolivia, Chile, India, Iran, and Peru; Wikipedia uses the classification as a “non-comparable biologic (NCB) version of rituximab”; link: https://en.wikipedia.org/wiki/Reditux. Also marketed in Paraguay by Farmasa as Tidecron®. Kikuzubam®, another biomimic of rituximab, is marketed by Probiomed in Bolivia, Chile, Mexico, and Peru.
A biosimilars must demonstrate equivalent efficacy and safety in head-to-head clinical studies with the originator biological. Biomimics fail to prove biosimilarity. Maybe Reditux® could prove to be a biosimilar to originator rituximab, but hasn’t done so as it has been approved in 2007 in India and won’t try to go to European or Northern American markets; until then it should be called a biomimic (I wouldn’t use the term “non-comparable biologic (NCB)”).
Take away message: Biomimics, also known as intended copies, are non-originator biologicals, that failed to prove biosimilarity.
Gilberto Castañeda-Hernández and colleagues: Biosimilars in rheumatology: what the clinician should know. http://rmdopen.bmj.com/content/1/1/e000010.full