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Biosimilars/General

Biosimilar naming in the US, the debate continues

Biosimilars/General | Posted 20/11/2015

The United States Pharmacopeial Convention (USP) has called on the US Food and Drug Administration (FDA) to reconsider its draft guidance Nonproprietary Naming of Biological Products: Guidance for Industry.

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Generics group established first voice for biosimilars in Canada

Biosimilars/General | Posted 27/04/2015

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.

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Australia’s DoH seeks feedback on biosimilars awareness project

Biosimilars/General | Posted 16/10/2015

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.

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Call for compulsory license for biosimilar trastuzumab emtansine

Biosimilars/General | Posted 23/10/2015

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).

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European paediatricians advocate biosimilar trials in children with IBD

Biosimilars/General | Posted 09/10/2015

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].

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Dutch medicines agency aims to clarify biosimilars confusion

Biosimilars/General | Posted 25/09/2015

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.

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Comments on FDA’s guidance on naming biologicals

Biosimilars/General | Posted 11/09/2015

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.

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Australian approval for infliximab biosimilar

Biosimilars/General | Posted 21/08/2015

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.

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ACR position statement on biosimilars addresses naming and substitution

Biosimilars/General | Posted 31/07/2015

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.

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Polish firm gets EIB loan for biosimilars development

Biosimilars/General | Posted 03/07/2015

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.