Biopharmaceuticals and Biosimilars

Basso, Angelina Maria Moreschi; Prado, Guilherme Souza; Pelegrini, Patrícia B.; Grossi‐de‐Sá, Maria Fátima

doi:10.1016/b978-0-444-63660-7.00002-4

Cited by 3 publications

(2 citation statements)

References 79 publications

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“…According to the FDA, these products are defined as highly similar drugs with no clinically significant differences from the already approved reference product from which they are derived [ 16 ]. Also called follow-on biologics (FOB) or subsequent entry biologics (SEBs), biosimilars are biopharmaceuticals that are produced and sold on the market after the expiration of patents for innovative biological products [ 17 ], when technology comes into the public domain and the originating company loses production exclusivity.…”

Section: Introductionmentioning

confidence: 99%

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Technological Advancements in Monoclonal Antibodies

Santos-Neto

Oliveira

Hodel

et al. 2021

The Scientific World Journal

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Biopharmaceuticals are innovative solutions that have revolutionized the treatment of important chronic diseases and malignancies. The approval of biosimilar products has become a complex and balanced process, and there are versions of drugs with established biosimilarity that can offer a more accessible treatment option to patients. The objective of this work was to identify the advancement of these technologies by means of patent and article analysis based on technological and scientific prospection. In patent document recovery, Derwent Innovation Index (DWPI) and PatentInspiration databases were used. The research was based on the search of the selected terms in the title, summary, and claims of the documents through a search strategy containing IPC code and keywords. In articles recovery, the Web of Science tool was used in the search of scientific publications dated from the last 5 years. The search resulted in a total of 2295 individual patent documents and 467 families using DWPI database, 769 individual patents and 205 families using PatentInspiration, and 2602 articles using Web of Science database. Additionally, this work describes the number of organizations that contribute to this area, where they are, how much development they have undergone, and the inventors/authors involved. Based on the number of publications registered, there is an important prominence for scientific research in mAbs. In terms of innovation, it is expected that several therapeutic drugs are already under regulatory review, which will allow drugs to be approved over the next few years and will thus generate a continuous flow of new products based on immunotherapies, mAbs, and biosimilar drugs. These drugs have become essential weapons for the treatment of significant diseases, and the increasing trend in the number of related scientific and technological publications contributes to making these therapies available to the greatest number of people.

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Section: Introductionmentioning

confidence: 99%

“…Since 2005, the European Medicines Agency (EMA) has approved more than 40 biosimilar drugs [ 12 ]. In 2012, 26 biosimilars were already in advanced stages and in 2015, another 47 in clinical trials [ 17 ]. In the past 3 years, 12 biosimilars have been approved by the FDA [ 46 ].…”

Section: Introductionmentioning

confidence: 99%

Technological Advancements in Monoclonal Antibodies

Santos-Neto

Oliveira

Hodel

et al. 2021

The Scientific World Journal

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Intact and middle‐down CIEF of commercial therapeutic monoclonal antibody products under non‐denaturing conditions

2020

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A two‐step CIEF with chemical mobilization was developed for charge profiling of the therapeutic mAb rituximab under non‐denaturing separation conditions. CIEF of the intact mAb was combined with a middle‐down approach analyzing Fc/2 and F(ab´)2 fragments after digest with a commercial cysteine protease (IdeS). CIEF methods were optimized separately for the intact mAb and its fragments due to their divergent pIs. Best resolution was achieved by combining Pharmalyte (PL) 8–10.5 with PL 3–10 for variants of intact rituximab and of F(ab´)2 fragments, respectively, whereas PL 6.7–7.7 in combination with PL 3–10 was used for Fc/2 variants. Charge heterogeneity in Fc/2 dominates over F(ab´)2. In addition, a copy product of rituximab, and adalimumab were analyzed. Both mAbs contain additional alkaline C‐terminal lysine variants as confirmed by digest with carboxypeptidase B. The optimized CIEF methods for intact mAb and Fc/2 were tested for their potential as platform approaches for these mAbs. The CIEF method for Fc/2 was slightly adapted in this process. The pI values for major intact mAb variants were determined by adjacent pI markers resulting in 9.29 (rituximab) and 8.42 (adalimumab). In total, seven to eight charge variants could be distinguished for intact adalimumab and rituximab, respectively.

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Monoclonal Antibodies Carried in Drug Delivery Nanosystems as a Strategy for Cancer Treatment

Silvestre

Oshiro

Garcia

et al. 2020

CMC

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Monoclonal antibodies carried in nanosystems have been extensively studied and reported as a promising tool for the treatment of various types of cancers. Monoclonal antibodies have great advantages for the treatment of cancer because their protein structure can bind to the target tissue; however, it has some challenges such as denaturation following heat exposure and extreme values of pH, temperature and solvents, the ability to undergo hydrolysis, oxidation and deamination and the formation of non-native aggregates, which totally compromises drug stability. In addition to these characteristics, they suffer rapid elimination when in the blood, which results in a short half-life and the production of neutralizing antibodies, rendering the doses ineffective. These challenges are overcome with encapsulation in nanosystems (liposomes, polymer nanoparticles, cyclodextrins, solid lipid nanoparticles, nanostructured lipid carriers, dendrimers and micelles) due to the characteristics of improving solubility, permeability, and selectivity only with tumor tissue; with that, there is a decrease in side effects beyond controlled release, which is critical to improving the therapeutic efficacy of cancer treatment. The article was divided into the different types of nanosystems, with a description of their definitions and applications in various types of cancers. Therefore, this review summarizes the use of monoclonal antibodies encapsulated in nanosystems and the description of clinical studies with biosimilars. Biosimilars are defined as products that are similar to monoclonal antibodies which are produced when the patent for the monoclonal antibodies expires.

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Biopharmaceuticals and Biosimilars

Cited by 3 publications

References 79 publications

Technological Advancements in Monoclonal Antibodies

Technological Advancements in Monoclonal Antibodies

Intact and middle‐down CIEF of commercial therapeutic monoclonal antibody products under non‐denaturing conditions

Monoclonal Antibodies Carried in Drug Delivery Nanosystems as a Strategy for Cancer Treatment

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