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Statistical Methods for Assessment of Complex Generic Drugs
Published in Wei Zhang, Fangrong Yan, Feng Chen, Shein-Chung Chow, Advanced Statistics in Regulatory Critical Clinical Initiatives, 2022
Generic drugs are drug products that contain the same Active Pharmaceutical Drug Ingredient (API) as an already marketed brand-name drug. A generic drug should be identical with its brand-name version in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. In many countries, generic drugs are approved through an Abbreviated New Drug Application (ANDA). In other words, generic drug applications are generally not required to demonstrate safety and effectiveness of the generic product through animal and clinical studies like innovative drugs. Instead, a generic drug application should demonstrate that the generic drug would follow a similar behavior in human body as its brand-name counterparts. Bioequivalence (BE) is a primary evidence for the approval of generic drugs. In the US Food and Drug Administration (FDA) guidance, BE is defined as “the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study” (US FDA, 2020a).
Equity lessons learned from pharmerging countries
Published in Songül Çınaroğlu, Equity and Healthcare Reform in Developing Economies, 2020
The increase in the consumption of medicines in Brazil is one of the reasons for the emergence of generic drug programs. As one of the pharmerging countries, Brazil has a large share of the generic pharmaceutical market (Barra and Albuquerque, 2011). According to the Brazilian Association of Generic Drug Industries, there are 120 generic drug manufacturers in Brazil who are responsible for more than 3800 recorded medicines that were manufactured as a result of more than 21,700 commercial presentations. From an equity perspective, affordability of medicines for the general population is another reason for the increase in share of the generic drug market in Brazil (Bertoldi et al., 2019). The cost-related advantage of generic drugs is obvious for Brazil. It became possible to treat the most prevalent diseases with generic drugs, which cost as much as 35% less than the brand name products. Moreover, the statistical yearbook for the 2016 pharmaceutical market showed that 1.46 billion generic drugs were marketed in Brazil (Aquino et al., 2018).
When I Control the Pain, I Control My Life: Opioids and Opioid-Containing Analgesic Medication in the Management of Chronic Intractable Pain
Published in Michael S. Margoles, Richard Weiner, Chronic PAIN, 2019
Some generic analgesic medications are less potent than the brand name medications they imitate. Some generic products will perform well for a number of individuals, but other individuals will not get the full potency effect. For most individuals who will need to use the medication for short periods of time, a generic may perform as well as a brand name product. However, chronic pain patients with constant (intractable) pain need predictable and continuous pain relief. Their way of living and earning a living may depend on obtaining predictable pain relief from a medication. Their need for analgesic medication may go on for years. Generic drugs may impair physical performance by providing less than optimal pain control as compared to the brand name product.
A randomized, double-blind, single-dose, two-way, parallel phase I clinical study comparing the pharmacokinetics and safety of adalimumab injecta and Humira® in healthy Chinese male volunteers
Published in Expert Opinion on Biological Therapy, 2022
Yanli Wang, Zhenyue Gao, Zhengzhi Liu, Guangwen Liu, Xinyao Qu, Jiahui Chen, Xinran Ren, Zhongnan Xu, Haimiao Yang
Compared with brand-name drugs, generic drugs contain the same active ingredients and have the same quality, safety and efficacy characteristics, while only a few inactive ingredients, such as pigments, flavorings and stabilizers, are different [12]. At present, many biosimilars of Humira® have been developed, such as BI 695501 [13] and adalimumab-adbm [1] produced by Boehringer Ingelheim, LBAL produced by LG Life Sciences Ltd [14]., FKB327 produced by Hammersmith Medicines Research Ltd [9] and MSB11022 produced by Merck [15]. Adalimumab injecta, a biosimilar of Humira® developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd (CTTQ), is a recombinant fully humanized TNF-α monoclonal antibody expressed in Chinese hamster ovary cells. The injecta dosage form and specifications are the same as the brand-name drug Humira®, which is mainly used for RA, psoriatic arthritis and ankylosing spondylitis.
Treatment patterns following initiation of generic glatiramer acetate among patients with multiple sclerosis from two large real-world databases in the United States
Published in Current Medical Research and Opinion, 2021
Jessica K. Alexander, Rinat Ariely, Ying Wu, Erin Hulbert, Allison Bryant, Zhaohui Su, Michaela Vardi, Jyotsna Kasturi
Glatiramer acetate (GA; Copaxonei) is indicated for the treatment of RMS, including clinically isolated syndrome, relapsing–remitting disease and active secondary progressive disease; it was initially approved by the Food and Drug Administration (FDA) in 19964. Glatopaii was the first FDA-approved generic follow-on glatiramer acetate (FOGA) product for MS patients, available in April 20155. According to the FDA, generic drugs are the same as branded drugs in dosage, safety, strength, how the drug is taken, quality, performance and intended use6. Generic drugs may, however, differ in certain other characteristics, such as packaging, excipients and storage conditions, which can affect an individual patient’s treatment experience7. In particular, there are compositional differences between branded GA and FOGA that may be associated with immunogenic and clinical outcomes12.
Buprenorphine implants: a model for expedited development and approval of new drugs
Published in Current Medical Research and Opinion, 2021
Michael Guarnieri, Jayanidhi Kedda, Betty Tyler
Generic drugs are defined as chemical products having the same molecular formula with similar manufacturing processes and inactive ingredients as the original product. These drugs have an expedited regulatory approval pathway1. Sponsors of the new product must demonstrate that the applicant drug has the same safety profile and affords the same bioavailability, that is, blood concentrations equivalent to the therapeutic concentrations of the referenced drug. Bioavailability thus refers to the extent and rate at which the drug enters systemic circulation, thereby accessing the site of action. Complex efficacy tests are not required for approval. Rather, efficacy can be inferred by demonstrating comparable bioavailability between the new and referenced product. This pathway allows medicines to reach the patient without going through time consuming clinical trials for effectiveness if the new product demonstrates safety and functional equivalence to the drug that already has been through these tests.