Globally, the availability and affordability of medicines are two of the most crucial factors for an effective healthcare system.
This is expressed in our constitution, which elevates access to basic healthcare services as one of the fundamental human rights.
In keeping with this constitutional obligation and the essence of equitability of medicines for the functioning of national healthcare systems, the competition commission has consistently addressed anticompetitive practices in the healthcare industry to improve the affordability and accessibility of medicines for all.
The commission's team of economists recently completed a working paper that sought to unpack the growing interest in more technologically advanced and clinically effective medicines such as biologicals and biosimilars, and the potential impact of this on our competition regulation efforts in this sector.
Working papers deal with topical issues and describe preliminary research findings that contribute to the development of new analytical or empirical approaches incorporated during the analysis processes (working papers are solely intended to elicit comments and stimulate debate).
According to their research, in the last decade there has been an increasing interest in more technologically advanced and clinically effective medicines such as biologicals and biosimilars.
Traditionally, most medicines are chemical-based and synthetically produced, and consist of small molecules.
A biologic, on the other hand, is protein-based. Similar to traditional medicines where the originator has a generic version, biologicals have an equivalent that is more affordable and equally effective, namely biosimilars.
A biosimilar is marketed once the patent for a biological has expired, and the biosimilar must contain the same protein of the biological. Biosimilar medicines are different from generic medication as they are not identical but similar to biologicals or originators in terms of safety, quality and effectiveness.
Therefore, it is imperative that biosimilars enter a market when the patent for the biological has expired to create price competition in the market and, simply explained, increase access to essential medicines. In July 2024, the commission identified anticompetitive practices by a pharmaceutical company that sought to limit the entry of generic tuberculosis medication through secondary patenting.
Given the positive impact that biosimilars have on price competition, our research team underscored findings that the biosimilar enters at a lower price than the biological, and secondly, that the biological usually decreases its price in response to the entry of the biosimilar.
It is evident that the entry of biosimilars encourages price competition which benefits consumers in the form of lower prices and increases access to essential medicines, as well as generating savings for the healthcare system.
The regulatory framework and guidelines also play a pivotal role in creating competition in the market. On the global front and in SA, there have been recent policy interventions and developments aimed at increasing uptake and greater access to biosimilar medicines.
The study also highlighted the positive developments in biosimilar manufacturing capacity expansion and localisation in SA, but there is scope for further biosimilar localisation, including development and manufacturing, to ensure efficient access of biosimilars in the SA market. Scaling-up of local biosimilar manufacturing capacity will, therefore, be important in ensuring that there is development and availability of more biosimilar medicines in the future. Visit www.compcom.co.za for more information about this white paper.
* Makunga is spokesperson for the competition commission of SA
SowetanLIVE
SIYABULELA MAKUNGA | Commission ensures affordable medicines
The entry of biosimilars encourages price competition, which benefits consumers
Image: 123RF
Globally, the availability and affordability of medicines are two of the most crucial factors for an effective healthcare system.
This is expressed in our constitution, which elevates access to basic healthcare services as one of the fundamental human rights.
In keeping with this constitutional obligation and the essence of equitability of medicines for the functioning of national healthcare systems, the competition commission has consistently addressed anticompetitive practices in the healthcare industry to improve the affordability and accessibility of medicines for all.
The commission's team of economists recently completed a working paper that sought to unpack the growing interest in more technologically advanced and clinically effective medicines such as biologicals and biosimilars, and the potential impact of this on our competition regulation efforts in this sector.
Working papers deal with topical issues and describe preliminary research findings that contribute to the development of new analytical or empirical approaches incorporated during the analysis processes (working papers are solely intended to elicit comments and stimulate debate).
According to their research, in the last decade there has been an increasing interest in more technologically advanced and clinically effective medicines such as biologicals and biosimilars.
Traditionally, most medicines are chemical-based and synthetically produced, and consist of small molecules.
A biologic, on the other hand, is protein-based. Similar to traditional medicines where the originator has a generic version, biologicals have an equivalent that is more affordable and equally effective, namely biosimilars.
A biosimilar is marketed once the patent for a biological has expired, and the biosimilar must contain the same protein of the biological. Biosimilar medicines are different from generic medication as they are not identical but similar to biologicals or originators in terms of safety, quality and effectiveness.
Therefore, it is imperative that biosimilars enter a market when the patent for the biological has expired to create price competition in the market and, simply explained, increase access to essential medicines. In July 2024, the commission identified anticompetitive practices by a pharmaceutical company that sought to limit the entry of generic tuberculosis medication through secondary patenting.
Given the positive impact that biosimilars have on price competition, our research team underscored findings that the biosimilar enters at a lower price than the biological, and secondly, that the biological usually decreases its price in response to the entry of the biosimilar.
It is evident that the entry of biosimilars encourages price competition which benefits consumers in the form of lower prices and increases access to essential medicines, as well as generating savings for the healthcare system.
The regulatory framework and guidelines also play a pivotal role in creating competition in the market. On the global front and in SA, there have been recent policy interventions and developments aimed at increasing uptake and greater access to biosimilar medicines.
The study also highlighted the positive developments in biosimilar manufacturing capacity expansion and localisation in SA, but there is scope for further biosimilar localisation, including development and manufacturing, to ensure efficient access of biosimilars in the SA market. Scaling-up of local biosimilar manufacturing capacity will, therefore, be important in ensuring that there is development and availability of more biosimilar medicines in the future. Visit www.compcom.co.za for more information about this white paper.
* Makunga is spokesperson for the competition commission of SA
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