**2. Regulations around generics**

Various countries have regulations for the development and availability of generic medicines. Generic medicines can be marked in a country only after a marketing authorization has been obtained. The US FDA requires generics to be identical to the originator products in pharmacokinetic and pharmacodynamic properties. There are defined parameters for establishment of bioequivalence of generic medicines to their branded counterparts. The FDA's Office of Generic Drugs (OGD) has a vigorous review process facilitating the approval of generic medicines of high quality [6]. The FDA also has clear directions for the development, review, and approval of biosimilars [7]. In the EU, the EMA reviews the quality standards and other parameters to establish the equivalence of a generic medicine to its innovator counterpart [8]. Various countries have described regulations for the production, review, and approval of generics though the regulatory frameworks are not equally mature in all countries [9, 10].

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*Perceptions and Challenges for Adoption of Generics and Biosimilars in Oncology*

Generic medicines are increasingly being used in most countries across the world. In the US, 9 out of 10 prescriptions are said to have a generic drug [1]. In the European Union (EU), about 20–80% prescriptions are filled with generics [11]. However, lower utilization of generics is reported in the lesser developed countries [12]. Not all generic medicines are available in all countries. Both

generics and biosimilars are widely used in hematological malignancies. Examples include lenalidomide for multiple myeloma, rituximab for Non-Hodgkin's lymphoma, chronic lymphocytic leukemia, and filgrastim for febrile neutropenia.

Generic medicines are lesser priced when compared to the innovator products and offer affordable options in management of various disease conditions including cancer [4, 13]. This has special relevance in low-income countries as it improves access and compliance to therapeutic options. Treatment regimens are associated with huge costs in oncology settings. The lesser price of generics and biosimilars is

The widespread use of generics has favorably influenced the national healthcare spending. The utilization of generics is influenced by various factors such as physician recommendations, pharmacy practices, patient preferences, and the economic status of the patient. The use of biosimilars is reported to have an average

The affordability of generics and biosimilars offers an opportunity for sustained engagement and adherence of patients to the treatment regimens [15]. This is of greater relevance in oncology where therapeutic options are expensive and treatments last long periods [16]. High costs of treatment are a common impediment in the management of cancer. Reduction of costs leads to enhanced access and adoption of generics [17, 18].

Though generic medicines have been available for several decades, there is paucity of knowledge about what these medicines are and how these differ from their innovator counterparts. There is also a lack of understanding about the standards described for the approval and market authorization of generics and how these

There are lacunae in knowledge about generics in physicians, healthcare professionals, and patients. This is evident in the perceptions that healthcare professionals and patients have for generics and biosimilars. These perceptions drive the apathy or antipathy for generics and impact the adoption of generics in routine practice. There are mixed perceptions regarding the use of generic medicines. The perceptions differ in various countries. While physicians in the high-income countries generally have positive perceptions for generics, those in the low-income countries generally have more negative perceptions [12, 20]. Controversies have emerged regarding the adoption of generics for brand substitution [21]. The differences in perceptions can be attributed to various factors including the regulatory milieu, healthcare policies, educational initiatives, and drug information sources.

reflective of the abbreviated pathways to regulatory approvals.

*DOI: http://dx.doi.org/10.5772/intechopen.85587*

**3. Use and impact of generics**

of 20–30% cost-saving effect [14].

**4. Perceptions and adoption of generics**

**3.2 Improved compliance**

drugs have a lower cost [19].

**3.1 Cost reduction**
