What are biologics and biosimilars?
Biologics and biosimilars are transforming the treatment of many conditions. They can provide an alternative to patients who have not benefitted from other treatments and can reduce strain on the current healthcare system.
Biologics and biosimilars are often thought of as pharmaceutical “copies”. They are made from a biological base, which means they are similar to, but not exactly the same as, existing pharmaceuticals that have already been licensed.
The TGA describes biologics as therapeutic goods that come from biological sources and are registered as medicines. A biosimilar, on the other hand, a version of an registered biologic that similar characteristics, efficacy and safety. These similarities are determined by comprehensive comparability studies. It is important to note that biosimilars are not generic biological medicines.
The biologic and biosimilar market
There is growing demand for biologics and biosimilars, as consumers and companies call for lower-cost healthcare solutions. The biosimilar market is expected to grow quickly over the next five years, as around US$70-80 billion worth of biologics is expected to lose exclusivity in this period and enable biosimilar development1.
More than 250 biosmilars are being developed globally (Biologic and Biosimilar Medicines 2020), and an increased availability of biologic and biosimilar medicines has the potential to make a meaningful, positive impact in Australian healthcare. 63% of respondents to PwC’s Challenges and Change 2015 pharmaceutical industry survey planned to develop biosimilars in the next two years.
Biologics and Biosimilar Medicines 2020
The Biologic and Biosimilar Medicines 2020 Forum was held on 23 June 2016 to bring together a broad range of representatives of the Australian healthcare industry to discuss the many opportunities and challenges presented by the availability of biologic and biosimilar medicines. The Forum formed the basis of Biologic and Biosimilar Medicines 2020: Making the most of the opportunities, a report that represents the perspectives of a diverse group of stakeholders, including patients, industry, pharmacists, prescribers and clinicians. AusBiotech was proud to be a member of the Forum’s Organising Committee.
Read the report, Biologic and Biosimilar Medicines 2020.
- Frost & Sullivan (2016). Global Generic Pharmaceuticals Market, Mountain View.