Biosimilars/General
Generics group established first voice for biosimilars in Canada
The Canadian Generic Pharmaceutical Association (CGPA), which represents Canada’s generics industry, announced on 7 April 2015 that it had set up a new CGPA Biosimilars Board, with Mr Michel Robidoux, President and General Manager of Sandoz Canada, as its inaugural Chair.
Australia’s DoH seeks feedback on biosimilars awareness project
Australia’s Department of Health (DoH) wants to improve awareness and confidence in biosimilars in the community and among healthcare professionals, including pharmacists and prescribers. To do this the DoH has developed an implementation framework, for which it is seeking feedback.
Call for compulsory license for biosimilar trastuzumab emtansine
A pressure group, which includes both patients and doctors, has called for the UK Government to overturn patents on Roche’s breast cancer treatment Kadcyla (trastuzumab emtansine).
European paediatricians advocate biosimilar trials in children with IBD
Paediatricians from Europe are concerned about the extrapolation of the limited amount of available clinical data from adults with rheumatologic diseases to children with inflammatory bowel disease (IBD) [1].
Dutch medicines agency aims to clarify biosimilars confusion
The Dutch Medicines Evaluation Board (MEB) has further clarified its position on biosimilars since its last update in March 2015. The MEB had previously raised concerns among patient groups and professional organizations with the announcement that biosimilars had no relevant differences to originators.
Comments on FDA’s guidance on naming biologicals
The US Food and Drug Administration (FDA) issued a draft guidance on the non-proprietary naming of biological products on 27 August 2015 [1], but not everyone is happy with the proposals made by the agency.
Australian approval for infliximab biosimilar
South Korean biotechnology company Celltrion announced on 10 August 2015 that its partner Hospira had gained approval from Australia’s drug regulator, the Therapeutic Goods Administration (TGA), for the infliximab biosimilar Inflectra.
ACR position statement on biosimilars addresses naming and substitution
The American College of Rheumatology (ACR) has issued a position statement on biosimilars, reflecting its views on issues such as interchangeability, substitution, naming and post-marketing surveillance of biosimilars.
Polish firm gets EIB loan for biosimilars development
The European Investment Bank (EIB) is lending Euros 45 million (around Zloty 185 million) to the largest Polish manufacturer of pharmaceuticals, Polpharma, for its research into, and development of, biosimilars.
Concerns raised over Australian decision to substitute biosimilars
In May 2015, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) recommended that originator biologicals could be substituted by biosimilars by physicians and pharmacists [1]. However, pharmacy companies, as well as physician and patient groups have reacted with concern over the decision.
