**3.1 Cost reduction**

*Advances in Hematologic Malignancies*

**Table 1.**

Regulatory approvals Small trials in healthy

*Key differences between generic medicines and biosimilar agents.*

**Parameter Generic drug Biosimilar**

volunteers/patients

medicine [2]." These regulatory directions of similarity imply the possible substitution of innovator products with generic medicines. According to the World Health Organization (WHO), a generic is a 'multisource pharmaceutical product which is intended to be interchangeable with the comparator product.' This also includes an originator brand for which the patent has expired. WHO has distinguished between originator brand, regardless of its patent status, and lowest-priced generic equivalents [3]. Biosimilars are defined as biologic products that are highly similar to reference products, notwithstanding minor differences in clinically inactive components. Biosimilars have no clinically meaningful differences to the reference product in terms of safety profile, purity, and potency [4]. Both generics and biosimilars are widely used in cancer care. However, there

Manufacturing Simple and predictable Stepwise to produce compound as similar as possible

Immunogenicity Low potential No increase in comparison to the reference biologic

to the originator biologic

immunogenicity

At least one study including assessments of pharmacokinetics, pharmacodynamics, and

Generic medicines may differ from the originator products in the manufacturing processes. There may be subtle differences in the excipients, color, and packaging. Sometimes, generic medicines may also have different formulations. According to the EMA, "a generic medicine's inactive ingredients, name, appearance and packaging can be different [2]." Approval of generics and biosimilars are granted after confirmation of evidence of biophysical similarity to the originator reference products. This is a proxy to similarity in the clinical effectiveness and safety of generics and biosimilars. Generics and biosimilars are approved only when there is 'totality of evidence' for similarity to the reference originator product. This includes robust scientific data for parameters of structural analysis, preclinical, pharmacokinetic, efficacy and safety, and

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

are several differences between the two agents (**Table 1**) [5].

**138**

immunogenicity.

**2. Regulations around generics**

not equally mature in all countries [9, 10].

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 reflective of the abbreviated pathways to regulatory approvals.

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 of 20–30% cost-saving effect [14].
