Biosimilars are pharmaceutical products that are almost identical copies of existing medicines.
Cancer Alliance publishes the first fact sheet on biosimilars in South Africa. The approval and availability of biosimilars will influence access and affordability of lifesaving medicines. Patients, clinicians and funders need to informed about these new opportunities to ensure that patients always have access to affordable, safe, efficacious and quality medicines. The approval of the first significant biosimilar for trastuzumab opens the opportunity for competition in the market. This will certainly pave the way for other biosimilars.
It took 5 years for the first biosimilar to be authorised for use in South Africa, when Cipla, in collaboration with Teva Pharmaceutical Industries Ltd launched Filgrastim Teva in 2018.
The first monoclonal antibody biosimilar to be registered in South Africa was for trastuzumab, when Biocon’s Ogivri®, with Mylan as the Applicant, was approved by SAHPRA on 15 May 2019.
This has opened up competition and will begin to effectively shape South African market access for the future.