Global support and standardization of regulation for biosimilars approval owes much of its legacy to the World Health Organization (WHO), since the first guidance by the organization on the matter was released in 2009. Since then, and with over a decade of research, the 202...
The Ministry for Health Labour and Welfare (MHLW) is the regulatory body in Japan responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in Japan and makes the decision on approval of drugs, including biologicals. The Pharmaceuticals and Medical Devices Age...
In order to further standardize and guide the research and development and evaluation of biosimilars, and provide technical reference for industry, researchers and regulatory agencies, the Center for Drug Evaluation has formulated the "Technical Guidelines for the Evaluation of Similarity and Indication Ex...
Comparing the early days of biosimilars in Europe against where we are now globally, it has been a long journey of searching for approval regulations and pathways. Initially, there was quite a bit of “feeling one’s way in the dark”, perhaps more so in ...
Regulatory evaluation of i.v. iron follow-on products is currently determined by the pathway for generic medicinal products. However, there is growing clinical [154., 155., 156., 157.] and non-clinical [158] evidence raising doubts about the interchangeability and/or substitutability of these ...
The CACA Guidelines for Holistic Integrative Management of Breast Cancer were edited to help improve the diagnosis and comprehensive treatment in China. Methods The Grading of Recommendations Assessment, Development and Evaluation (GRADE) was used to classify evidence and consensus. Results The CACA ...
9 Repair of lytic bone lesions on bone scan after treatment may show scintillation or increased activity and thus be misdiagnosed as disease progression. PET-CT is superior to CT and bone scan in terms of efficacy evaluation, but its further application is impeded by the lack of ...
To date, no biosimilars for rheumatoid arthritis have been approved. Rheumatoid Arthritis and Skin Cancer The committee grappled with several other controversies. One of the hottest debates centered on the treatment of high-risk patients, such as those with rheumatoid arthritis plus hepatitis B, ...
In Europe, this has been fully acknowledged by the European Agency for the Evaluation of Medicinal Products (EMEA), and is reflected by the fact that these products are named biosimilars, and not generics or biogenerics (in the USA and Japan they are called follow-on protein products, and ...
Further evaluation of effects on G-CSF, CD34+ cell dosing, and body weight may be of increasing importance as a cost-saving measure. Question 4: How do you manage thrombocytopenia? Leukapheresis procedures usually result in a decrease in platelet count. Although some variability may exist in ...