A generic medication is a copy of an original drug for which the patent has expired. It contains the same active substances and is equivalent in terms of safety, efficacy, and pharmaceutical quality. Generic drugs are produced after the expiration of the brand-name drug\'s patent, which enables greater competition and reduces costs for patients and healthcare systems. They are subjected to strict regulatory and quality control standards to ensure compliance with pharmaceutical norms. This study aims to determine the current status of generic drug prescribing within the medical departments of the Mohammed VI University Hospital (UH) of Marrakesh. This is a cross-sectional study with descriptive and analytical aims, involving 224 prescriptions issued in the medical departments of the Mohammed VI University Hospital (UH) of Marrakesh. To obtain the data required for the study, we included medical records, prescription sheets, and prescriptions delivered to hospitalized patients. In our study, 224 prescriptions were analyzed, with an overall total of 989 prescribed drugs, and a mean of 4.42 +- 2.39 drugs per prescription. Prescriptions from the Psychiatry Department accounted for 258 (26.09%) of total prescriptions, followed by those from the Cardiology Department at 130 (13.14%) and the Internal Medicine Department at 114 (11.53%). The generic prescribing rate for the UH\'s medical departments was 403 (40.75%). The Oncology Department had the highest generic prescribing rate (27 (64.29%)), followed by the Infectious Diseases and Rheumatology departments, at 29 (63.04%) and 34 (60.71%), respectively. In contrast, the Psychiatry Department had a generic prescribing rate of just 54 (20.93%). The most frequently prescribed classes as generic drugs were gastric antisecretory agents at 39 (100%), antiemetics at 32 (94.12%), and antivirals at nine (81.82%). The vast majority of drugs, 896 (90.59%), were reimbursable. In conclusion, we have noted that the generic drug prescription rate at the UH remains average compared with other institutions, and needs to be improved to optimize resources and control healthcare costs.

The use of generic specialty medications amongst individuals with multiple sclerosis (MS) has expanded due to an increase in the number of available agents. We describe a woman who was denied continued use of brand name teriflunomide (AubagioⓇ), despite being clinically stable for 2.5 years, and switched to generic teriflunomide. She experienced a significant spinal cord exacerbation within a few months of starting treatment. We analyzed 3 generic teriflunomide agents, including the one used for treatment, in addition to AubagioⓇ. The generic teriflunomide used by our patient contained 55.5 % content of the labeled amount, well below U.S. FDA specifications.

The national centralized drug procurement (NCDP) policy, known as the \"4 + 7\" policy in China, has transformed pharmaceutical procurement and access by leveraging healthcare institutions\' collective buying power to reduce drug prices substantially. This policy has profoundly impacted drug pricing mechanisms, healthcare expenditures, market dynamics, and the quality of available drugs. This commentary evaluates the efficacy, challenges, and broader implications of the NCDP, summarizes the current state of post-marketing monitoring of selected generic drugs for centralized procurement, and presents relevant considerations.

UNASSIGNED: The Bioavailability/Bioequivalence Unit (BA/BE Unit) of the Department of Pharmacology and Toxicology, College of Medicine, University of the Philippines Manila which has not been operational since 2012, is due for renewal of its accreditation. To date, there are only three Philippine Food and Drug Administration-accredited laboratories that perform bioequivalence studies in the Philippines. One of the prerequisites of registering specific generic medicines is the conduct of Bioequivalence (BE) studies which are performed to ensure that the generic drug is at par with the innovator drug. Thus, this study aimed to determine the feasibility of re-establishing the BA/BE Unit as a bioequivalence testing center.
UNASSIGNED: The feasibility study done is a qualitative descriptive analysis based on expansive literature review and performance of SWOT analysis within the BA/BE unit. Literatures were selected based on its assessed relevance to the study. The databases checked were PubMed and Google Scholar. The terms used were from the Medical Subject Heading (MeSH) including feasibility studies, therapeutic equivalency, and generic drugs. Literature review was performed on the factors affecting the four types of feasibility studies (market, technical, financial, and organizational). A SWOT analysis of the BA/BE Unit was done through the review of records and documents of previous BE studies and focus group discussion among the BA/BE Unit team members.
UNASSIGNED: The BA/BE Unit conducted 24 bioequivalence studies from 2006-2009 and still receives inquiries from drug companies. It implements its QMS throughout the pre-analytical, analytical, and post-analytical stages of the workflow. Its organizational structure consists of qualified professionals with updated GCP and GLP certificates. Because of the adequately equipped facility, lower honoraria for government-employed personnel, and lower expenses for laboratories and in-patient admissions, the cost of conducting a bioequivalence study in the BA/BE Unit will be lower than in other BE centers.
UNASSIGNED: Based on the SWOT analysis and market, technical, financial, and organizational considerations, re-establishing the BA/BE Unit as a bioequivalence testing center is feasible.

Biosimilars have the potential to greatly reduce US spending on biologic drugs, but uptake of these competitor products varies. We used Open Payments data from 2014 to 2022 to proxy for direct-to-physician marketing and compared levels of activity between biologic and biosimilar drug manufacturers. Our analysis focused on 6 reference biologics that recently faced competition in the years immediately before and after the launch of the first biosimilar. We used Medicare Part B dosage units to measure market penetration of biosimilars and its relationship with biosimilar marketing activity. Last, we conducted a sensitivity test, comparing payments for primarily office- or hospital-based physicians, using affiliations constructed from Medicare Carrier claims. Reference biologic manufacturers greatly reduced the amount of direct-to-physician marketing in the post-launch period. Biosimilar manufacturers generally engaged in low levels of activity relative to the historic performance of reference biologics. These trends were consistent across office- and hospital-based physicians. The intensity of biosimilars\' direct-to-physician marketing also had no apparent relationship with achieved market penetration. Our findings demonstrate that persistently high market shares of reference biologics cannot be explained by ongoing direct-to-physician marketing activities. At the same time, while such activities could educate physicians or induce switching, biosimilar entrants engaged in little direct-to-physician marketing.

UNASSIGNED: The Coronavirus disease of 2019 (COVID-19) pandemic has imposed several challenges leading to the shortage of medications due to the disruption of their supply chains. Among others, patients using psychotropics encountered difficulties finding their medication despite the efforts of investing in local production. Encouraging patients to use generic drugs can be an effective strategy to ensure sustainable access to medication.
UNASSIGNED: This study aimed to describe the consumption of psychotropic medications during the COVID-19 pandemic and the willingness together with the reasons for using generic drugs. It also assessed the association between generic drugs and the general characteristics of the patients.
UNASSIGNED: A cross-sectional study was performed over a period of 4 months (July-October 2021) targeting 128 patients using psychotropic drugs.
UNASSIGNED: The sample included more women than men with a mean age of 38 years. Antidepressants were the psychotropic medications mostly consumed followed by anti-anxiety medications. Almost 13% of the patients started using psychotropics either through self-prescription or a friend\'s advice and 73.4% used generic drugs. Fear of dependence, unavailability of the brand drug, and pharmacist\'s recommendation were the main reported reasons for using generic drugs.
UNASSIGNED: During the COVID-19 pandemic, the consumption of psychotropics increased due to new prescriptions and self-medication. No differences were noted between using generics and the characteristics of the patients in contrast to previous studies which support the implementation of generic prescription and substitution policies.

BACKGROUND: This retrospective analysis aimed to comprehensively review the design and regulatory aspects of bioequivalence trials submitted to the Saudi Food and Drug Authority (SFDA) since 2017.
METHODS: This was a retrospective, comprehensive analysis study. The Data extracted from the SFDA bioequivalence assessment reports were analyzed for reviewing the overall design and regulatory aspects of the successful bioequivalence trials, exploring the impact of the coefficient of variation of within-subject variability (CVw) on some design aspects, and providing an in-depth assessment of bioequivalence trial submissions that were deemed insufficient in demonstrating bioequivalence.
RESULTS: A total of 590 bioequivalence trials were included of which 521 demonstrated bioequivalence (440 single active pharmaceutical ingredients [APIs] and 81 fixed combinations). Most of the successful trials were for cardiovascular drugs (84 out of 521 [16.1%]), and the 2 × 2 crossover design was used in 455 (87.3%) trials. The sample size tended to increase with the increase in the CVw in trials of single APIs. Biopharmaceutics Classification System Class II and IV drugs accounted for the majority of highly variable drugs (58 out of 82 [70.7%]) in the study. Most of the 51 rejected trials were rejected due to concerns related to the study center (n = 21 [41.2%]).
CONCLUSIONS: This comprehensive analysis provides valuable insights into the regulatory and design aspects of bioequivalence trials and can inform future research and assist in identifying opportunities for improvement in conducting bioequivalence trials in Saudi Arabia.

UNASSIGNED: Generic medications are cost-effective without compromising therapeutic outcomes. Therefore, the goal of this study was to investigate, using a cross-sectional study design, the factors influencing Saudi Arabian consumers\' preferences between innovator and generic medications.
UNASSIGNED: This cross-sectional study was carried out in Saudi Arabia using a Google survey form. For data collection, a simple random sampling strategy was used. The recruited participants were surveyed using a validated questionnaire that focused on six influencing domains: physician, pharmacist, perceived effectiveness, price, information availability, and confidence based on prior experience. The obtained data was used to analyze factors that have an association with any of the six domains using multinomial regression analysis. A correlation analysis was performed to examine the relationship between domains.
UNASSIGNED: The 317 participants included 64.4 % females, 52 % aged ≥ 26, and a large proportion of Saudi nationals (82.6 %) and university graduates (78.9 %). Being employed (OR:3.029; P = 0.006; CI: 6.715-1.366), a healthcare providers (OR:2.298; P = 0.043; CI: 5.151-1.025), and having insurance coverage (OR:1.908; P = 0.017; CI: 3.245-1.122) had a greater influence on medication selection. Participants with linguistic and business educational backgrounds (OR:3.443; P = 0.022; CI: 9.950-1.191), those living in the northern region of Saudi Arabia (OR:3.174; P = 0.009; CI: 7.585-1.328), having chronic ailments (OR:3.863; P = 0.013; CI: 11.274-1.324), and possess insurance (OR:1.748; P = 0.039; CI: 2.971-1.028) get readily influenced by pharmacist. People who were married and lived in Saudi Arabia\'s southern region were influenced by perceived effectiveness when choosing medicine. Participants from the northern region were found to be influenced by the price of the medicines, information about the medicines, and confidence based on previous experience. The price of medicines has a significant impact on those suffering from chronic diseases. At a significant level of P = 0.01, all six influencing domains were found to be positively correlated with each other.
UNASSIGNED: The study shows that healthcare providers, drug prices, perceived efficacy, and information availability all have a big influence on the Saudi Arabian population\'s choice of medications. Educational background, location, and chronic disease status are associated with several influencing domains. Aside from public awareness campaigns, healthcare professionals should be involved in the implementation of the generic medication policy.

UNASSIGNED: The 2022 Inflation Reduction Act authorizes Medicare to negotiate the prices of 10 drugs in 2026 and additional drugs thereafter. Understanding the sociodemographic and spending characteristics of beneficiaries taking these specific drugs could be important describing the impact of the legislation.
UNASSIGNED: To describe sociodemographic and spending characteristics of Medicare beneficiaries who use the 10 prescription drugs (\"negotiated drugs\") that will face Medicare drug price negotiations in 2026.
UNASSIGNED: A 20% sample of Medicare Part D beneficiaries from 2020 (n = 10,224,642) was used. Sociodemographic and spending characteristics were descriptively reported for beneficiaries taking the negotiated drugs, including subgroups by low-income subsidy (LIS) status and by drug, and for Part D beneficiaries not taking negotiated drugs.
UNASSIGNED: Part D beneficiaries taking a negotiated drug compared with Part D beneficiaries not taking a negotiated drug overall had similar sociodemographic characteristics, more comorbidities (3.9 vs 2.2) and higher mean [median] Medicare ($33,882 [$18,251] vs $12,366 [$3,429]) and out-of-pocket (OOP) spending ($813 [$307] vs $441 [$160]). There was variation in characteristics by LIS status. The mean age was highest among non-LIS beneficiaries taking a negotiated drug compared with LIS beneficiaries taking a negotiated drug and beneficiaries not taking a negotiated drug (76.2 vs 69.9 vs 71.4). Among beneficiaries using negotiated drugs, a higher percentage of LIS beneficiaries compared with non-LIS was female (59.7% vs 48.0%), was Black (20.9% vs 6.6%), and resided in lower-income areas (39.1% vs 20.3%). Mean [median] annual Part D OOP spending for negotiated drugs was $115 [$59] for beneficiaries with LIS and $1,475 [$1,204] for beneficiaries without LIS. There were also differences depending on which negotiated drug was used. Drugs for cancer and blood clots had the highest proportions of White users, whereas type 2 diabetes and heart failure drugs had the highest proportions of Black users and beneficiaries residing in lower-income areas. Annual Part D OOP costs were lowest for sitagliptin (LIS: $104 [$60], non-LIS: $1,391 [$1,153]) and highest for ibrutinib (LIS: $649 [$649], non-LIS: $6,449 [$6,867]). Among non-LIS beneficiaries, 24% (22% to 76%) had more than $2,000 in OOP costs.
UNASSIGNED: Inflation Reduction Act OOP spending caps and LIS expansion will lower prescription drug costs for beneficiaries with OOP costs exceeding $2,000 who are mostly White and live in higher-income areas, insulin users who are disproportionately Black with multiple chronic conditions, and beneficiaries with low incomes. However, these provisions will not impact the 76% of non-LIS beneficiaries using negotiated drugs who have OOP costs that are still substantial but below $2,000. Negotiations could reduce OOP costs through reduced coinsurance payments for this group, which is older and has more chronic conditions compared with beneficiaries not taking negotiated drugs. Part D plan design, spending, and utilization changes should be monitored after negotiation to determine if further solutions are needed to lower OOP costs for this group.

OBJECTIVE: Due to constantly rising therapy costs, biosimilars and generic drugs have gained tremendous importance through recent decades. Nevertheless, the acceptance among healthcare workers regarding biosimilars and generic drugs in previously published international studies is considerably lower than the scientific data on equivalent safety and efficacy would suggest. The aim of this questionnaire-based survey was to determine the perception and knowledge regarding generic drugs and biosimilars by medical professionals from different healthcare facilities in Vienna, Austria.
METHODS: The online questionnaire was sent to public and religious hospitals in Vienna, including the university hospital \"Vienna General Hospital.\" In addition, doctors\' offices were reached by sending out the questionnaire in the weekly news of the Vienna Medical Association.
RESULTS: A total of 282 physicians and 311 graduated nurses took part in the study. 63% and 62% of the participants were convinced that generic respective biosimilar drugs were clinically equivalent to the original reference drug. On average, 1.6 out of 4 knowledge questions were answered correctly about generics, while only 0.87 out of 4 questions were answered accurately about biosimilars.
CONCLUSIONS: The results of this study support the outcome from previous surveys demonstrating that a large proportion of healthcare professionals is still skeptical about generics and biosimilars. According to the results of this study, better education of the medical staff might ensure greater acceptance of these types of drugs.