Regulatory
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, 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 »
Health Canada’s perspective on the clinical development of biosimilars and related scientific and regulatory challenges
Author(s): 1 Ally Pen, PhD, Agnes V Klein, MD, DPH, Jian Wang, MD, PhD
Page: 36-41
Abstract: Biologicals have offered a new avenue for targeting therapy to treat life-threatening and chronic diseases. The recent or pending patent expirations of many successful biologicals have permitted the marketing… Read More »
Regulation of biologicals in Malaysia
Author(s): Arpah Abas, BPharm, Yvonne Siew Khoon Khoo, BPharm (Hons) MMedSc, PhD (Pharmacology)
Page: 193-8
Abstract: The regulatory oversight of biologicals in Malaysia is established by the National Pharmaceutical Control Bureau (NPCB), Ministry of Health. At the agency, the Section on Biotechnology Product Registration exercises… Read More »
Comparison of biosimilars guidelines
Abstract: This paper provides a detailed comparison of biosimilars guidelines issued in Canada, the European Union, Japan and Korea; and by the World Health Organization (WHO). This comparison highlights the… Read More »
Biosimilar development and regulation in Japan
Abstract: In Japan, biosimilars guidelines following the principles of the EU framework were established by Japan’s Ministry of Health, Labor and Welfare in March 2009. The guidelines cover the manufacturing… Read More »