Because biosimilars have many specific and unique considerations related to regulatory approval, specific guidelines have been developed by the EMA, FDA, and World Health Organization (WHO) [1, 2, 6]. There are slight differences between the guidelines, but all suggest taking a step-by-step approach to proving biosimilarity with the author [1, 2, 6]. A biosimilar is much like a generic version of a biologic drug, but there are important differences. For example, unlike a generic, a biosimilar is not an exact copy of its brand name drug. There are many biologic drugs, such as immunotherapy drugs, that are now used to treat cancer, and some have biosimilar versions available. Some biosimilars have been approved to treat certain cancers, and others have been approved to treat side effects. For more information, see the list of biosimilars used in the treatment of cancer. Davio K.`s oncologists discuss the role of biosimilars in cancer treatment at the NCCN`s annual conference. The Centre for Biosimilars.
2018. Accessed www.centerforbiosimilars.com/news/oncologists-address-the-role-of-biosimilars-in-cancer-care-at-nccn-annual-conference March 3, 2020. Another important factor on the demand side is the views of specialists and patient groups regarding biosimilars. Physicians who have years of experience with the reference biologic may be reluctant to replace a biosimilar, even for new patients, until sufficient experience has been gained in clinical practice, as opposed to clinical trials. To drive demand, it may be necessary for biosimilar companies to build “reputational bonds” with physicians through strategies similar to those used by brand companies that communicate information to establish brand equity through diabetes details, publications, advertisements, and educational programs. In addition, patient assistance programs and contracts with health plans, pharmacy benefit managers (PBMs), hospitals or provider groups that have control over treatment choice may be targeted to influence the economic supply associated with the adoption of biosimilars. These measures will increase the cost of distribution and commercialization of biosimilars compared to small molecule generics, where these marketing and distribution costs are minimal and demand is determined solely by lower prices and pharmacy contracts for availability. Once a drug has been placed on the market by the FDA, it must be re-evaluated for safety and efficacy every six months for the first and second year. After that, re-evaluations are carried out annually and the result of the assessment must be communicated to authorities such as the FDA.
Biosimilars should be subject to pharmacovigilance regulations (PVG) as a reference product. Therefore, biosimilars approved by the EMA must submit a risk management plan (RMP) with the application for authorisation and submit regular safety update reports after the product has been placed on the market. The RMP contains the safety profile of the drug and proposes prospective pharmacovigilance studies. Biologics are among the fastest growing segments of the prescription market. FDA approval of additional biosimilars and interchangeable biosimilars can help boost competition. Patients will have more treatment options and potentially more cost-effective alternatives. An animated video for patients explains important facts about biosimilars and how the EMA works to ensure they are as safe and effective as their reference biologics. Lexicon of terms and definitions used to describe biosimilars The penetration rate of biosimilars should vary depending on the indication of the disease, the type of patient, the physician`s specialty and other factors.
As mentioned earlier, acceptance rates of biosimilars by patients and physicians should be lower if the biosimilar does not have an interchangeability assessment. In addition, acceptance rates of biosimilars may vary depending on medical and patient-centered factors, such as: whether the physician`s specialty is historically more price sensitive or has a higher degree of brand loyalty in the choice of treatment (e.g., allergists vs. rheumatologists); whether biosimilars are used long-term as maintenance therapy or only once or twice (especially in the absence of long-term clinical data); whether the indication is life-threatening or the effects of a therapeutic non-response or side effects are perceived to be very serious; or if the difference in patient usability or expense of the brand instead of the biosimilar should be high. A biosimilar is a biotherapeutic whose quality, safety and efficacy are similar to those of an already approved reference biotherapeutic, with “similarity” defined as the absence of a relevant difference in the endpoint of interest.3 Pediatric rheumatologists have questioned whether biosimilars will have identical biological functions, since even minor changes in manufacturing can impair biological functions. including pharmacokinetics, immunogenetics, glycosylation, sialysis, stability, safety and efficacy. Differences in these parameters have the ability to significantly alter affinity, which is the primary determinant of the pharmacokinetic and pharmacodynamic profile of mAbs and Cepts, thus influencing dosing regimens.3 Current guidelines require that only PK equivalence for generic (non-biologic) drugs be demonstrated. For biologics, comprehensive non-clinical physiochemical and biological characterization is required to address structural, functional, and immunogenic concerns regarding efficacy and safety studies.237 Currently, clinical data requirements differ in the European Union and the United States, but both require randomized clinical trials to demonstrate equivalent safety and efficacy demonstrated in the short term. term. To have to. Rare events and long-term safety are assessed through post-market safety monitoring studies.3 It is unclear how the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act are applied to biosimilars in the United States. The EU has been a pioneer in the regulation of biosimilars by creating a strong framework for their authorisation and shaping the development of biosimilars worldwide. “About biosimilars and interchangeable products.” U.S.
Food And Drug Administration, 2020, www.fda.gov/drugs/biosimilars/biosimilar-and-interchangeable-products#biosimilar. (accessed October 18, 2020).