Regulatory
Pelmeg®, a biosimilar pegfilgrastim developed in the context of evolving regulatory guidelines
Author(s): Dirk Lehnick, PhD, Hendrik Wessels, PhD, Josef Höfler, PhD, Karsten Roth, PhD, Ulrike Scholz, PhD
Page: 125-31
Author byline as per print journal: Karsten Roth, PhD; Hendrik Wessels, PhD; Josef Höfler, PhD; Ulrike Scholz, PhD; Dirk Lehnick, PhD Abstract: Pelmeg® is a biosimilar pegfilgrastim, which obtained European… Read More »
Biosimilar regulation and approval in Jordan
Author(s): Hayel Obeidat, MD, Rana Musa Ali Al-ali "Malkawi", MSc, Wesal Salem Al-haqaish, BPharm
Page: 77-8
Author byline as per print journal: Rana Musa Ali Al-ali “Malkawi”, MSc; Wesal Salem Al Haqaish, BPharm; Hayel Obeidat, MD Abstract: The regulatory oversight of medicinal products in Jordan is… Read More »
Regulation of copy biologicals in China
Abstract: The first draft guidelines for copy biologicals were introduced in China back in 2014. The Technical Guideline was then updated and finalized in 2015. In this paper, how the… Read More »
Regulations for biotherapeutics approval in Colombia
Author(s): Francisco Javier Sierra Esteban, MSc, Johanna Andrea García Cortes, MSc
Page: 26-8
Author byline as per print journal: Johanna Andrea García Cortes, MSc; Francisco Javier Sierra Esteban, MSc Abstract: Colombia is in the process of implementing legislation to allow for the approval… Read More »
The EU is ready for non-biological complex medicinal products
Author(s): Falk Ehmann, MD, PhD, MSc, Ruben Pita, PharmD, LLM
Page: 30-5
Abstract: This paper describes the existing European Union legislation and scientific guidance to adequately assess the quality, safety and efficacy, as well as the lifecycle management, of the group of… Read More »
Pricing of biosimilars in Saudi Arabia
Author(s): Ali M Alhomaidan, PhD, Fahad S Alnutaifi, MHEcon, MPH, Ibrahim A Aljuffali, MSc,PhD, Nasseruddeen A AL-Howaimel, MSc
Page: 27-9
Author byline as per print journal: Ali M Alhomaidan, PhD; Ibrahim A Aljuffali, MSc, PhD; Fahad S Alnutaifi, MHEcon, MPH; Nasseruddeen A AL-Howaimel, MSc Abstract: Innovation in the pharmaceutical industry… Read More »
Regulatory requirements for the development and registration of biosimilars in South Africa
Author(s): 1 Henry MJ Leng, PhD, Khamusi Philip Mutoti, BSc, BPharm Sci, Professor Nontombe Mbelle, MChB, MMed, FC Path (CMSA)
Page: 150-2
Abstract: In South Africa, medicines are registered and regulated in terms of the Medicines and Related Substances Control Act (Act 101 of 1965), as amended, and the regulations to this… Read More »
Korean regulations for biosimilars
Abstract: Regulations for biosimilars in the Republic of Korea have been in place since 2009. Since then, the country has also put in place specific guidelines and approved four biosimilars.… Read More »
Update on US state legislation on biosimilars substitution
Abstract: Since the biosimilars pathway was introduced, many US states have been considering, or have introduced, legislation to allow for substitution of biosimilars deemed interchangeable. This paper gives an update… Read More »