**5. Challenges for switch and adoption**

With the prevalent perceptions about generics, there are several likely challenges that physicians and patients can confront for the adoption of these drugs. Observational studies have confirmed doubts and unfavorable attitudes in physicians, pharmacists, and lay people for the effectiveness, safety, and quality of generic medicines [27]. There may be questions regarding the dependable and acceptable evidence for the effectiveness and safety of generics and biosimilars. There may be uncertainties regarding the acceptance of bioequivalence as a marker of similarity. These uncertainties may lead to cohesive discussions in media and scientific platforms which in turn may influence the decision-making for switch and substitution with generics and biosimilars.

Physicians may want to go for facility visits to understand and inspect the development and manufacturing of generics. This can build trust in the products and facilitate their early and easy adoption. Consistent product supply may be taken as a proxy to dependable quality and this can safeguard the trust in the product of a particular supplier. On the other hand, physicians may feel reassured regarding safety if the generic or biosimilar has been approved in a regulated market with clear guidance for development and approval of these products.

### **6. Efforts by companies and physicians**

Physicians should make sustained efforts to discuss the most cost-effective therapeutic options with patients and help them to achieve desired outcomes at lower costs [35, 36]. This may be an important aspect of therapy in low income

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are phased and last longer.

**8. Recommendations**

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

countries with majority of patients belonging to the poorer segments [37]. Many of these countries have ill-defined reimbursement policies and healthcare management is largely an out-of-pocket expense. Not alone physicians, pharmacists have an important role in the switch and substitution of generics and biosimilars [14]. Company sponsored patient assistance programs (PAP) have a huge potential to improve access to generics and biosimilars. These programs offer medicines to eligible patients at no or minimal costs [38]. Companies should also make efforts to educate patients, inform physicians, and demonstrate benefits to payers for their products.

Healthcare systems should prepare for increased adoption of generics and biosimilars by procurement and formulary management, continued safety surveillance, and transformational reforms for mitigating the economic and operational challenges. A healthcare system should aim to allow an equitable access to essential medicines of assured quality, efficacy, and safety [39]. Policies and programs should aim to not only improve access but also build trust in medicine quality and healthcare systems [40]. Procurement of high-quality generics is the first and key step that acts as a gatekeeper to the access and adoption of generics and biosimilars in a particular country. These practices need to be standardized and implemented as nation-wide initiatives for successful utilization of generics. Efforts should be made to develop and design a prequalification scheme to assist countries lacking strong regulations in procurement of anticancer generics and biosimilars of assured quality [13]. Regulators are making constant efforts to improve the knowledge and understanding for the development and clinical use of biosimilars. In collaboration with the European Commission, the EMA has formulated an information guide for healthcare professionals to educate them about the development, approval, effectiveness, safety, switch, substitution, and interchangeability of biosimilars [8]. Such efforts need to be replicated by the healthcare systems in countries with poor regulations. Manufacturers can collaborate with the healthcare systems to plan and implement educational programs for physicians, pharmacists, and patients. Physicians should be educated for the criteria of equivalence, safety and vigilance, and manufacturing

processes adopted for developing high-quality generics and biosimilars.

There is lack of unawareness for the costs of pharmaceutical therapies in physicians [41]. Educational programs should aim to improve understanding for the lower costs of generics and biosimilars and the implications of this on overall cost of therapy.

Payers should be encouraged to develop appropriate reimbursement policies that will encourage the use of generic medicines in routine clinical practice. Further, a pool of generic suppliers should be identified to ensure an uninterrupted availability of these medicines [13]. Generic medicines and biosimilars should be included in the national lists of essential medicines and should be part of national formularies. The integrity of supply chains should be maintained and circulation of counterfeit or substandard products should be discouraged. Lack of constant drug supplies can lead to mistrust in patients and lack of confidence in physicians and healthcare systems. All these factors compromise clinical care in oncology where treatments

Most experience about the knowledge and perceptions regarding generics comes from interviews and surveys conducted in cross sections of populations in various

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

**7. Role of healthcare systems**

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

countries with majority of patients belonging to the poorer segments [37]. Many of these countries have ill-defined reimbursement policies and healthcare management is largely an out-of-pocket expense. Not alone physicians, pharmacists have an important role in the switch and substitution of generics and biosimilars [14].

Company sponsored patient assistance programs (PAP) have a huge potential to improve access to generics and biosimilars. These programs offer medicines to eligible patients at no or minimal costs [38]. Companies should also make efforts to educate patients, inform physicians, and demonstrate benefits to payers for their products.
