Biosimilars

Bioton and Medipolis sign insulin analogue technology licensing agreement

Biosimilars/News | Posted 05/10/2012

Polish biotechnology company Bioton and Finnish-based contract research organisation (CRO) Medipolis GMP (Medipolis) have signed a licensing agreement on the manufacturing technology of an insulin analogue.

Naming and interchangeability of biosimilars raised in new survey

Biosimilars/General | Posted 05/10/2012

The contentious issues of naming and interchangeability of biosimilars in the US have been raised once again, as a result of a survey carried out by the Alliance for Safe Biologic Medicines (ASBM). The survey, released on 13 September 2012, examined physician practices and perspectives with regard to identification and substitution of biosimilars. These remain issues that are as yet unresolved by FDA.

Roche does not see a threat from biosimilars until 2015

Biosimilars/News | Posted 21/09/2012

Switzerland-based drugmaker F. Hoffmann-La Roche (Roche) expects results from 19 late-stage clinical trials over the next 18 months to provide a stream of products to offset potential near-term threats to its cancer drugs Herceptin (trastuzumab) and Rituxan (rituximab).

Boehringer Ingelheim starts biosimilar rituximab trial

Biosimilars/Research | Posted 21/09/2012

Germany-based Boehringer Ingelheim Pharmaceuticals (Boehringer Ingelheim) is starting a Phase III trial for a biosimilar version of rituximab.

Sun recalls biosimilar brain treatment

Biosimilars/News | Posted 21/09/2012

India-based Sun Pharmaceutical Industries (Sun Pharma) is once again in the news, but for the wrong reasons.

Biosimilar comparability debate continues

Biosimilars/Research | Posted 14/09/2012

Authors Schellekens and Moors comment on the response from EMA’s Biosimilar Medicinal Products Working Party to questions that they raised regarding EMA’s comprehensive biosimilar regulatory pathway [1]. While the authors express their appreciation of the openness of EMA in the way it has pioneered the biosimilars pathway in Europe, they still argue that EMA has failed to show the scientific need for biosimilar comparability [2].

Teva receives FDA approval for filgrastim in the US

Biosimilars/News | Posted 14/09/2012

Teva Pharmaceutical Industries (Teva) announced on 30 August 2012 that FDA had granted approval for tbo-filgrastim (XM02 filgrastim), the first new granulocyte colony-stimulating factor (G-CSF) to be approved in the US in more than 10 years.

Dr Reddy’s plans EU launch for biosimilar rituximab

Biosimilars/News | Posted 14/09/2012

India-based generics drugmaker Dr Reddy’s Laboratories (Dr Reddy’s) is planning to launch its biosimilar monoclonal antibody Reditux (rituximab) in Europe.

EMA responds to questions over biosimilar comparability

Biosimilars/Research | Posted 07/09/2012

EMA has responded to questions regarding its comprehensive biosimilar regulatory pathway. The pathway, which includes the need for new clinical trials and comparability studies that demonstrate quality, efficacy, and safety, has been accused of proving to be a barrier for the development of clinically superior compounds [1].

‘Similar biologics’ approved and marketed in India

Biosimilars/General | Posted 07/09/2012

Last update: 15 February 2018

There have been established guidelines for approving generic versions of small molecule chemical drugs in India for some time already. However, no specific guidelines for ‘similar biologics’, as the Indian regulatory authorities call these products, existed in India until 2012. This has been the case despite the fact that the requirements for granting regulatory approval for such ‘similar biologics’ required more data than for a simple generic drug application [1].