Biosimilar monoclonal antibodies: a science-based regulatory challenge

¹

,

²

,

³

et al. 2016

Abstract

Smart CitationsHow this paper cites the one you are viewing

“…Thus, full knowledge of the production process of the innovator medicine is not available as it is mainly protected by trade secret. Contrary to highly predictable chemical processes, the biological production process is more difficult to control (Lepage-Nefkens et al, 2013 ), and quality attributes of the product are highly influenced by changes in the production process, e.g., different expression system, growth conditions,… (Declerck, 2013 ). This complicates the reverse engineering of biological medicines, and therefore the production of a highly similar biological medicine.…”

Section: Results

mentioning

confidence: 99%

“…However, with the long development time and slow market uptake, the risk remains that an innovative treatment replaces the competitive power of a biosimilar mAb before the biosimilar has become profitable (Declerck, 2013 ).…”

Section: Results

mentioning

confidence: 99%

See 1 more Smart Citation

Overcoming Barriers to the Market Access of Biosimilars in the European Union: The Case of Biosimilar Monoclonal Antibodies

¹

,

²

,

³

et al. 2016

Abstract

Smart CitationsHow this paper cites the one you are viewing

“…Thus, full knowledge of the production process of the innovator medicine is not available as it is mainly protected by trade secret. Contrary to highly predictable chemical processes, the biological production process is more difficult to control (Lepage-Nefkens et al, 2013 ), and quality attributes of the product are highly influenced by changes in the production process, e.g., different expression system, growth conditions,… (Declerck, 2013 ). This complicates the reverse engineering of biological medicines, and therefore the production of a highly similar biological medicine.…”

Section: Results

mentioning

confidence: 99%

“…However, with the long development time and slow market uptake, the risk remains that an innovative treatment replaces the competitive power of a biosimilar mAb before the biosimilar has become profitable (Declerck, 2013 ).…”

Section: Results

mentioning

confidence: 99%

Contribution of animal studies to evaluate the similarity of biosimilars to reference products

van Meer¹,

Ebbers

²

,

Kooijman

³

et al. 2015

Drug Discovery Today

Abstract

Smart CitationsHow this paper cites the one you are viewing

“…These are species-specific products and the nonhuman primate is often the only available relevant species [46]. However, the relevance of studies with biosimilar applications with nonhuman primates is limited and studies in these or irrelevant animal models are not recommended [44,47,48]. For monoclonal antibodies specifically, the effects that are seen in repeat-dose toxicity studies generally conform to the intended pharmacology.…”

Section: Discussion

mentioning

confidence: 99%

Developments in the treatment of moderate to severe ulcerative colitis: focus on adalimumab

Freeman

¹

2013

TCRM

Smart CitationsHow this paper cites the one you are viewing

“……”

Section: Discussion

mentioning

confidence: 99%

Overcoming Barriers to the Market Access of Biosimilars in the European Union: The Case of Biosimilar Monoclonal Antibodies

¹

,

²

,

³

et al. 2016

Abstract

Smart CitationsHow this paper cites the one you are viewing

“…Thus, full knowledge of the production process of the innovator medicine is not available as it is mainly protected by trade secret. Contrary to highly predictable chemical processes, the biological production process is more difficult to control (Lepage-Nefkens et al, 2013 ), and quality attributes of the product are highly influenced by changes in the production process, e.g., different expression system, growth conditions,… (Declerck, 2013 ). This complicates the reverse engineering of biological medicines, and therefore the production of a highly similar biological medicine.…”

Section: Results

mentioning

confidence: 99%

“…However, with the long development time and slow market uptake, the risk remains that an innovative treatment replaces the competitive power of a biosimilar mAb before the biosimilar has become profitable (Declerck, 2013 ).…”

Section: Results

mentioning

confidence: 99%

Contribution of animal studies to evaluate the similarity of biosimilars to reference products

van Meer¹,

Ebbers

²

,

Kooijman

³

et al. 2015

Drug Discovery Today

Abstract

Smart CitationsHow this paper cites the one you are viewing

“…These are species-specific products and the nonhuman primate is often the only available relevant species [46]. However, the relevance of studies with biosimilar applications with nonhuman primates is limited and studies in these or irrelevant animal models are not recommended [44,47,48]. For monoclonal antibodies specifically, the effects that are seen in repeat-dose toxicity studies generally conform to the intended pharmacology.…”

Section: Discussion

mentioning

confidence: 99%

Developments in the treatment of moderate to severe ulcerative colitis: focus on adalimumab

Freeman

¹

2013

TCRM

Smart CitationsHow this paper cites the one you are viewing

“……”

Section: Discussion

mentioning

confidence: 99%

Overcoming Barriers to the Market Access of Biosimilars in the European Union: The Case of Biosimilar Monoclonal Antibodies

¹

,

²

,

³

et al. 2016

Abstract

Smart CitationsHow this paper cites the one you are viewing

“…Thus, full knowledge of the production process of the innovator medicine is not available as it is mainly protected by trade secret. Contrary to highly predictable chemical processes, the biological production process is more difficult to control (Lepage-Nefkens et al, 2013 ), and quality attributes of the product are highly influenced by changes in the production process, e.g., different expression system, growth conditions,… (Declerck, 2013 ). This complicates the reverse engineering of biological medicines, and therefore the production of a highly similar biological medicine.…”

Section: Results

mentioning

confidence: 99%

“…However, with the long development time and slow market uptake, the risk remains that an innovative treatment replaces the competitive power of a biosimilar mAb before the biosimilar has become profitable (Declerck, 2013 ).…”

Section: Results

mentioning

confidence: 99%

Contribution of animal studies to evaluate the similarity of biosimilars to reference products

van Meer¹,

Ebbers

²

,

Kooijman

³

et al. 2015

Drug Discovery Today

Abstract

Smart CitationsHow this paper cites the one you are viewing

“…These are species-specific products and the nonhuman primate is often the only available relevant species [46]. However, the relevance of studies with biosimilar applications with nonhuman primates is limited and studies in these or irrelevant animal models are not recommended [44,47,48]. For monoclonal antibodies specifically, the effects that are seen in repeat-dose toxicity studies generally conform to the intended pharmacology.…”

Section: Discussion

mentioning

confidence: 99%

Developments in the treatment of moderate to severe ulcerative colitis: focus on adalimumab

Freeman

¹

2013

TCRM

Smart CitationsHow this paper cites the one you are viewing

“……”

Section: Discussion

mentioning

confidence: 99%