Home / The Intriguing World of Biosimilars
NZCR was delighted recently to learn that a drug tested in their ‘HEBE’ trial has recently been granted FDA (US Food and Drug Administration) approval – as well as being approved for sale in 37 other countries worldwide – including New Zealand.
The drug Selarsdi is a treatment for psoriasis and active psoriatic arthritis and works by reducing inflammation and thus pain. Both these medical conditions are quite prevalent worldwide with approximately 125 million people worldwide suffering psoriasis and over 9 million living with active psoriatic arthritis.
Selarsdi is part of a class of drugs known as ‘biosimilars’. These are organic drugs whose compound makeup is near or identical to the original drug (known as the ‘reference medicine’) and are usually developed by competing pharmaceutical companies once the original drug comes off patent or other legal protection.
Many of these off-patent drugs are known as “generic drugs”, however, if the drug is made from a living organism (as is the case in some vaccines and treatments for conditions such as cancer), they are called ‘biosimilars’. The key differences between a ‘generic’ and a ‘biosimilar’ are its molecular structure and a usually far higher cost and complexity involved in the development of a biosimilar. The multitude of paracetamol brands are a great example of ‘generic’ drugs, whilst the common treatment for breast cancer called Herceptin, is a reference drug for the ‘biosimilar’ brands of Herzuma and Ontruzant.
Like the drug it was based on, the biosimilar is a similar drug, manufactured by a different company. Drug approval organisations throughout the world rightly demand that the biosimilars go through the same medical testing and approval protocol as the innovative medicine, to prove efficacy, effectiveness and document any side effects.
Biosimilar studies therefore are usually more predictable in their outcomes and side effects than original investigational drug clinical trials. The treatment being trialled is expected to react in much the same way as the original innovator treatment reacted. For this reason, many medical trial participants feel very comfortable participating in a biosimilar study.
Biosimilars help bring down the cost of drugs to patients and thus increase access to millions more people.
The FDA approval of Selarsdi brings access to this life-improving biosimilar to 38 countries now (including NZ) and will be on the market in early 2025.
Thanks to all the HEBE participants for helping make this drug a reality and increasing access to drugs for more people worldwide. Read the published journal paper here.
