Biosimilars are like generic medicines in their ability to reduce healthcare costs and increase patient access to life changing medicines
- The relatively new but growing class of biologic medicines brings significant clinical improvement to patients, especially in the area of cancer. The term “biologics” most often refers to therapeutic proteins manufactured by recombinant technologies and include, for example, growth hormone, insulin, erythropoietin and antibodies. In contrast to chemical molecules, biologics are much bigger, more complicated to produce, have certain immunogenicity concerns and display a generally higher variability since they are produced by living cells.
- Like all medicines, biologics have a time-limited patent protection and once exclusivity expires, other companies can produce follow-on versions with the promise of lower costs to the health care system and increased patient access to these life changing medicines.
- For biologics, these are called “biosimilars” and correspond in principle with generics for chemical medicines – with one major difference. While generics can be 100% identical to the original molecule, this cannot be proven with biosimilars as ALL biologics include an inherent amount of variability. This can be the result of batch-to-batch variability, as well as manufacturing changes, among others. Biosimilars are approved biologics that have been demonstrated to be highly similar to a reference product.
- When a biosimilar is approved by the TGA as a clinically comparable version of the reference product, the biosimilar should generally be considered as interchangeable. This means that a patient can expect an equivalent outcome with either treatment with regard to safety and efficacy.
- The scientific principles for establishing biosimilarity are the same as those for demonstrating comparability after a change in the manufacturing process of an already licensed biological.
- Structural variances between a biosimilar and the originator are only acceptable within the heterogeneity pattern of the molecule. Any variances need to be explained and justified with regard to the potential impact on clinical performance.
- Biosimilars have been used safely and effectively in the EU since 2006 and Australia since 2011 with over 1.5m patient days in Australia and 400 million in the EU.