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Introduction
Published in Wei Zhang, Fangrong Yan, Feng Chen, Shein-Chung Chow, Advanced Statistics in Regulatory Critical Clinical Initiatives, 2022
Wei Zhang, Fangrong Yan, Feng Chen, Shein-Chung Chow
Like GDUFA, it was first enacted in 2012 to enable FDA to collect fees from biosimilar companies to aid in the assessment of development programs and applications for marketing approval. A biosimilar is to a reference biological product what a generic is to a brand drug, often referred to as the reference listed drug. BsUFA authorizes FDA (specifically the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER)) to assess and collect fees for biosimilar biological products. FDA dedicates these fees toward expediting the review process for biosimilar biological products. BsUFA facilitates the development of safe and effective biosimilar products for the American public.
Little Pharma and Friends
Published in Mickey C. Smith, E.M. (Mick) Kolassa, Walter Steven Pray, Government, Big Pharma, and the People, 2020
Mickey C. Smith, E.M. (Mick) Kolassa, Walter Steven Pray
A biosimilar is a biologic medical product that is “almost” an identical copy of an original product offered by another company. The original product is, however, still protected by Patent. Thus, you can’t market a product that is still protected by Patent but you can, with FDA approval, market one that’s “almost” the same. The FDA has come up with something called the 351a Pathway – an abbreviated licensure pathway for biological products shown to be biosimilar to or interchangeable with a reference product. This Regulation was made possible Legislation, the Biologics Competition and Innovation Act, signed by the President in 2010. Think of it as a sort of Waxman–Hatch for biologics.
Generics and Biosimilars
Published in Shein-Chung Chow, Innovative Statistics in Regulatory Science, 2019
Biosimilars or follow-on biologics are fundamentally different from those of traditional chemical generic drugs. Unlike traditional chemical generic drug products, which contain identical active ingredient(s), the generic versions of biologic products are made of living cells. Unlike classical generics, biosimilars are not identical to their originator products and therefore should not be brought to market using the same procedure applied to generics. This is partly a reflection of the complexities of manufacturing and safety and efficacy controls of biosimilars when compared to their small molecule generic counterparts (see, e.g., Chirino and Mire-Sluis, 2004; Schellekens, 2004; Crommelin et al., 2005; Roger and Mikhail, 2007).
Real-world outcomes following switching from anti-TNF reference products to biosimilars for the treatment of psoriasis
Published in Journal of Dermatological Treatment, 2023
Rachel C. Ruda, Katherine A. Kelly, Steven R. Feldman
Biosimilars are biologic medical products that are highly similar to their reference products without clinically meaningful differences in safety or effectiveness (4). As a result of the large molecular size and complexity of biological therapies, variability exists between each batch of biologics, both for reference products and biosimilars. While biosimilars are not exact duplicates of reference products, different batches of the reference product are also not exact matches of previous batches (5). The development and approval of biosimilars require rigorous standards of quality, safety, and efficacy. However, in comparison to the approval process for biologics, the approval for biosimilars places greater emphasis on pre-clinical physicochemical and functional characterization at the earlier stages of development and less on clinical trials (6). These equivalence studies typically require smaller sample sizes than those for studies on the approval of novel biologics and do not need to be repeated for every indication of the reference product leading to a reduced cost of development (7).
Estimating the impact of biosimilar entry on prices and expenditures in rheumatoid arthritis: a case study of targeted immune modulators
Published in Journal of Medical Economics, 2022
Ervant J. Maksabedian Hernandez, Marlon Graf, Alexandria Portelli, Jason Shafrin
Competition between biologics and biosimilars differs materially from branded and generic small molecules. First, biologics are harder to replicate due to the complex nature of molecules, making biosimilars riskier and costlier to develop than generics for small molecules5. Biosimilars are required by the FDA to show no clinically meaningful difference in terms of their safety, purity, and potency from their biologic reference counterpart. Second, biosimilars—unlike generics—are not perfect copies of the reference product. This is one of the factors that limit physician and patient uptake6. Third, only two biosimilars have attained the FDA’s “interchangeable” designation so far7, the required label for a pharmacy-level treatment switch. In the absence of this label, switching decisions remain clinical, rather than administrative. Fourth, many high-cost biologics may end up on favorable formulary tiers, compared with their biosimilar alternatives, due to the potential for manufacturer rebates8–10. All of these factors may have limited the US market penetration of biosimilars in some therapeutic areas. Although the FDA has approved 36 biosimilars across 11 reference products11, only 21 biosimilars are currently available to patients11,12.
Biosimilarity of HS-20090 to Denosumab in healthy Chinese subjects: a randomized, double-blinded, pharmacokinetics/pharmacodynamics study
Published in Expert Opinion on Investigational Drugs, 2022
Yaqi Lin, Heng Yang, Xiaoyan Yang, Can Guo, Shuang Yang, Guoping Yang, Qiong Wu, Chao Pan, Changan Sun, Chuan Li, Liangliang He, Jie Huang, Qi Pei
A biosimilar is a biologic product that is highly similar to a biologic drug that has been approved. It must demonstrate a high similarity to a licensed reference product and have no clinically meaningful differences in terms of safety, purity, and potency [1]. Unlike traditional small-molecule drugs, biologics have a high level of molecular complexity and can be extremely sensitive to changes in multifaceted production procedures. Despite the heterogeneity, all biopharmaceuticals, including biosimilars, must maintain consistent quality and clinical performance throughout their lifecycle [2]. Both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have issued guidance for biopharmaceutical sponsors to demonstrate a proposed biosimilar product having adequate biosimilarity to a reference product. The totality of the evidence should be provided, which is based on data from sequentially conducted analytical studies, animal studies, human PK/PD studies, and additional clinical studies [1,3]. The development of biosimilar therapies as alternatives in multiple therapeutic areas can improve patient accessibility and reduce medicine-related costs [4].