Position of Generic Drugs in Oncology: What Are Their Main Advantages?

Introduction

Generics generally derive from small molecule drugs that are mostly synthetically manufactured. The Medicines Act precisely defines a generic as a medicinal product that has the same qualitative and quantitative composition in terms of active substances and the same pharmaceutical form as the reference medicinal product and for which bioequivalence with the reference medicinal product has been demonstrated by bioavailability studies (except in cases where it can be demonstrated that the generic meets the criteria specified by relevant guidelines).

The advantage of generics is that their development costs are significantly lower, typically only a fraction compared to the original product. Therefore, in many countries, they have overtaken the original medicinal products in terms of the number of consumed packages. In oncology, they are utilized in both curative and palliative treatment, in chemotherapy, and supportive therapy.

The Position of Generics in Oncology Treatment

In the United States, generics account for 9 out of 10 drug prescriptions, while in the European Union, the share of generic prescriptions ranges from 20% to 80%. As mentioned earlier, one of their main advantages is the lower development cost, making them an accessible option in the treatment of oncological diseases and many other pathological conditions. Their use leads to a reduction in public spending and patient costs, which can be reflected in adherence.

The positive perception and acceptance of generics are limited by knowledge gaps among healthcare professionals. In economically developed countries, generics are perceived more positively than in less developed economies. One factor affecting the acceptance of generics in regular practice is the question of efficacy. Generic drugs are brought to market after a bioequivalence study is conducted. This is a standard and reliable process that confirms that the generic has similar pharmacokinetics to the original drug. Although it does not directly measure it, bioequivalence also indicates similar efficacy of the products. The benefits of the original therapy are thus retained even when the patient switches from the original drug to a generic. For example, in hemato-oncological treatment, it is reported that a switch to generic therapy does not affect the cytogenetic or molecular response to the treatment.

Generics do not lag behind in terms of safety profiles either. To date, there is no evidence of inferiority of generics compared to original medicinal products in terms of therapy safety. Additionally, spontaneous reporting of adverse events is increasingly applied to generics, and they are strictly monitored within pharmacovigilance. The development and production of generics also undergo standard quality assessments, such as stability verification, sterility, and impurity content.

Conclusion

Generics represent an important part of oncological therapy. Their main advantage is the lower cost of therapy compared to original medicinal products while maintaining comparable efficacy and safety. While the lower cost of generic treatment may raise concerns about its efficacy and safety, these fears have not been confirmed for generics that adhere to high standards of development and production.

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Sources:

1. Garg A., Csn D., Jandoo T. Perceptions and challenges for adoption of generics and biosimilars in oncology. In: Hamid G. A. Advances in hematologic malignancies. IntechOpen, 2019, doi: 10.5772/intechopen.85587.
2. Suchopár J. Original and generic medicinal products, biological and biosimilar medicinal products, and non-biological complex drugs. Remedia 2015; 25 (5): 364–369.