Biological drugs are the treatment in areas such as oncology, diabetes or autoimmune diseases, among others. Consequently, biosimilars are a reality in the global health panorama.
Biosimilar drugs, particularly those from monoclonal antibodies, have a high growing potential due to a favorable context marked by robust regulatory frameworks and by the expected patent expiration for the coming years.
By 2020, the global biologic market is expected to grow to almost $400bn, by which time biologics will account for up to 28% by value of the global market for pharmaceuticals.11
This growth is principally due to:
- The launch of new biologic products.
- An increase in diagnosis of certain pathologies.
- Price increases.
Biosimilars are expected to be a cost-effective alternative to high-priced branded biologics, resulting in a positive impact for the main stakeholders:
- Opportunities to treat more patients with appropriate therapies (physicians).
- Cost savings and financial sustainability of healthcare systems (payers).
- Improved access to medicines (patients).
- Reasonable return of investment with the continued attractiveness of R&D investment in new medicines development (industry).12,13
Biosimilars can offer significant and much needed cost savings to both payers and patients.12
These savings should increase in line with the introduction of more biosimilars within the same therapeutic class.
By 2020 total savings across the main European countries and the US have been estimated to between €49bn and €98bn.11
Between 2011 and 2016 we have seen steady growth in the volume of biosimilars in development (from the pre-clinical phase to phase III) .14
From 71 in 2011 to approximately 289 in 2016 – a growth of 32% .14
The main therapeutic areas in terms of biosimilars development are oncology and inflammatory diseases.14
By 2025 several biologic patents will have expired in many countries, and this could translate into an opportunity to develop new biosimilars. Europe will be the region with more opportunities. 14
- Delivering on the Potential of Biosimilar Medicines. The Role of Functioning Competitive Markets. Available on: http://www.medicinesforeurope.com/wpcontent/uploads/2016/03/IMSInstitute-Biosimilar-Report-March-2016-FINAL.pdf.
- Ventola C. Biosimilars. Part 1: Proposed regulatory criteria for FDA approval.P&T.2013;38(5):270-87.
- GfK Market Access. 9th September 2014.
- Micklus A. Biosimilars Portfolio and Pipeline Trends, 2016. Hot Topic. Ref Code: DMKC0166679.