**4.1 Effectiveness**

Though generic medicines have an established equal effectiveness to their innovator counterparts and are intended to be interchangeable with the latter, they

#### **Figure 1.**

*Use and adoption of generics and biosimilars. GRAF (generic dRug adoption framework) is a tool to identify and differentiate high quality generics.*

**141**

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

are perceived to be less efficacious effective. Physicians and healthcare professionals need to understand how confirmation of similar clinical outcomes is key to the regulatory review process for the approval of generics and biosimilars. Bioequivalence is a standard and reliable measure to confirm the similar effectiveness of generics and their branded counterparts. Bioequivalence is a dependable proxy for similar clinical effects [22]. Therapeutic benefits are maintained when patients receiving innovator drugs are switched over to generic options of the same dosing. In the setting of oncology, this switch is not reported to impact the cytogenetic or molecular response [23]. The demonstration of equivalence and increasing awareness for the same can help physicians and healthcare professionals in easy decision making for a

The likely differences in manufacturing and excipients between generics and innovator products raise concerns about the safety of generics. Safety is usually measured in terms of the number and frequency of adverse effects with the clinical use of a pharmaceutical product. There is no established evidence for the inferiority of generic medicines for any safety parameters. However, there is a growing trend towards the enhanced reporting of safety experiences with generics. This is sugges-

Continued safety monitoring is increasingly being applied to generics and biosimilars. Any efforts made to set up such systems build trust and acceptance for the generic molecules. The exposure of generics to stringent pharmacovigilance practices in the regulated markets are a proxy to established safety of the products. The safety monitoring systems in the regulated markets are mature and reliable. These systems allow for the easy identification of generics in the reports. For example, in the US, the FDA adverse event reporting system (FEARS) enables the identification of generic drugs in the safety reporting systems [26]. If approved and marketed in countries with such regulations, generic medicines are perceived to hold a promise

tive of increased surveillance for the safety of generics [24, 25].

of safety. This facilitates the easy adoption of such approved products.

[27]. These perceptions impact the utilization of generics.

Generic medicines and biosimilars are perceived as low-cost alternatives to expensive originator anticancer drugs. Many patients perceive generics as less efficacious; physicians and pharmacists continue to doubt the safety of generics

There are smaller price differentials between biosimilars and biopharmaceuticals when compared to generics and their comparator originators. This is explained by the longer development time and larger research costs for biosimilars. Costeffectiveness and cost-utility analyses are being used to establish the economic benefits of adopting biosimilars. Such economic evaluations have a role in checking the rapidly rising healthcare expenditures [28]. However, there is a lack of regulatory directions for the most appropriate techniques of economic evaluation for

The benefits of cost saving options are manifold. Patients may seek affordable options, physicians may be reassured by the willingness and ability of patients to complete the therapy, and payers may view this as a pharmacoeconomic reform. The WHO has described cost of therapy as a key component of rational prescribing [29]. Payers, physicians, and patients are developing an incline to evaluate the pharmacoeconomics of generics and biosimilars periodically throughout the life cycle of the product. This is explained by the increasingly available experience in the

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

switch to generic options.

**4.2 Safety**

**4.3 Cost**

generics and biosimilars.

**Figure 2.** *Components of perceptions and levers for adoption of generics.*

#### *Perceptions and Challenges for Adoption of Generics and Biosimilars in Oncology DOI: http://dx.doi.org/10.5772/intechopen.85587*

are perceived to be less efficacious effective. Physicians and healthcare professionals need to understand how confirmation of similar clinical outcomes is key to the regulatory review process for the approval of generics and biosimilars. Bioequivalence is a standard and reliable measure to confirm the similar effectiveness of generics and their branded counterparts. Bioequivalence is a dependable proxy for similar clinical effects [22]. Therapeutic benefits are maintained when patients receiving innovator drugs are switched over to generic options of the same dosing. In the setting of oncology, this switch is not reported to impact the cytogenetic or molecular response [23]. The demonstration of equivalence and increasing awareness for the same can help physicians and healthcare professionals in easy decision making for a switch to generic options.

#### **4.2 Safety**

*Advances in Hematologic Malignancies*

in social and scientific platforms.

categories (**Figure 2**).

**4.1 Effectiveness**

**Figure 1.**

*and differentiate high quality generics.*

Perceptions regarding generics and biosimilars and attitudes of physicians, healthcare providers, and patients impact the use of generics (**Figure 1**). Several factors may impact the acceptance and use of generics. These factors are diverse and include increased knowledge about the regulated approval of generics and biosimilars and the increased awareness regarding generics from the access to information

Perceptions and levers for adoption of generics may be grouped into four broad

Though generic medicines have an established equal effectiveness to their innovator counterparts and are intended to be interchangeable with the latter, they

*Use and adoption of generics and biosimilars. GRAF (generic dRug adoption framework) is a tool to identify* 

**140**

**Figure 2.**

*Components of perceptions and levers for adoption of generics.*

The likely differences in manufacturing and excipients between generics and innovator products raise concerns about the safety of generics. Safety is usually measured in terms of the number and frequency of adverse effects with the clinical use of a pharmaceutical product. There is no established evidence for the inferiority of generic medicines for any safety parameters. However, there is a growing trend towards the enhanced reporting of safety experiences with generics. This is suggestive of increased surveillance for the safety of generics [24, 25].

Continued safety monitoring is increasingly being applied to generics and biosimilars. Any efforts made to set up such systems build trust and acceptance for the generic molecules. The exposure of generics to stringent pharmacovigilance practices in the regulated markets are a proxy to established safety of the products. The safety monitoring systems in the regulated markets are mature and reliable. These systems allow for the easy identification of generics in the reports. For example, in the US, the FDA adverse event reporting system (FEARS) enables the identification of generic drugs in the safety reporting systems [26]. If approved and marketed in countries with such regulations, generic medicines are perceived to hold a promise of safety. This facilitates the easy adoption of such approved products.

#### **4.3 Cost**

Generic medicines and biosimilars are perceived as low-cost alternatives to expensive originator anticancer drugs. Many patients perceive generics as less efficacious; physicians and pharmacists continue to doubt the safety of generics [27]. These perceptions impact the utilization of generics.

There are smaller price differentials between biosimilars and biopharmaceuticals when compared to generics and their comparator originators. This is explained by the longer development time and larger research costs for biosimilars. Costeffectiveness and cost-utility analyses are being used to establish the economic benefits of adopting biosimilars. Such economic evaluations have a role in checking the rapidly rising healthcare expenditures [28]. However, there is a lack of regulatory directions for the most appropriate techniques of economic evaluation for generics and biosimilars.

The benefits of cost saving options are manifold. Patients may seek affordable options, physicians may be reassured by the willingness and ability of patients to complete the therapy, and payers may view this as a pharmacoeconomic reform. The WHO has described cost of therapy as a key component of rational prescribing [29].

Payers, physicians, and patients are developing an incline to evaluate the pharmacoeconomics of generics and biosimilars periodically throughout the life cycle of the product. This is explained by the increasingly available experience in the

real-world settings with these products. Economic efficiency is not solely determined by the relative costs of generics and comparators. It is ideally defined by the attainable levels of efficiency and safety with the use of lower-priced options. This eventually constitutes the quality of the generics and biosimilars [30]. In a cost minimization study in Colombia, use of generic equivalents of bortezomib, decitabine and capecitabine resulted in substantial savings of 63% (USD 4.68 million), 26% (USD 0.29 million), and 46% (USD 1.50 million), respectively [31].

#### **4.4 Quality**

Quality is a key parameter that impacts the utilization of generics. It is important to understand the perceptions about quality of generics and also define what parameters define quality of generics.

The regulatory standards for approval of generics and biosimilars are guided by the principles of quality by design (QbD) [32]. This implies that science-driven and risk-based concepts underlie the development, scale-up, and manufacturing of generics and biosimilars. The yield of this approach is a high-quality generic product or biosimilar molecule with an implied clinical equivalence which may be validated in research studies and clinical experience. Quality is not alone limited to structural and chemical similarities during development; it also spans to the similarities of generic drugs to comparators in final formulations and packaging. Quality is also defined by testing for stability, sterility, and impurities. These data are an important and mandatory component of abbreviated new drug applications (ANDAs) [33]. The WHO has defined standards for good manufacturing practices (GMP) as a guide to the quality assurance of pharmaceutical products [34].
