Biosimilars

Successful phase III trial of biosimilar r-FSH

Biosimilars/News | Posted 18/06/2012

Finox Biotech announced on 6 June 2012 that the company’s pivotal phase III study with Afolia, a biosimilar recombinant follicle stimulating hormone (r-FSH), in patients undergoing assisted reproduction technology (ART), had met its primary endpoint.

Merck KGaA and Dr Reddy’s to collaborate on biosimilar mAbs

Biosimilars/News | Posted 08/06/2012

Pharma major Merck KGaA announced on 6 June 2012 its first steps into the biosimilars market, with an agreement with India-based generics manufacturer Dr Reddy’s Laboratories (Dr Reddy’s) to co-develop biosimilar cancer drugs.

Prescriber caution is likely over biosimilars

Biosimilars/Research | Posted 01/06/2012

The experience with generic medicines is a sign that prescribers are likely to be cautious, and in some cases concerned, about the use of biosimilars as alternatives to brand-name drugs.

Alternative delivery devices for biosimilars

Biosimilars/News | Posted 01/06/2012

FDA, in its draft guidance for biosimilars, has said that biosimilars can use different drug delivery devices than the corresponding reference product.

Biosimilars approved and marketed in The Netherlands

Biosimilars/General | Posted 01/06/2012

Last updated: 1 June 2012

The Dutch Medicines Evaluation Board (MEB) – College ter Beoordeling van Geneesmiddelen (CBG) – is responsible for the approval of marketing authorisation of medicinal products including biosimilars in The Netherlands.

FDA’s public hearing on biosimilars draft guidances

Biosimilars/General | Posted 25/05/2012

On 11 May 2012, FDA held a public hearing to gain input on their draft guidances relating to the development of biosimilar products and it seems that the guidances were generally well accepted.

Immunogenicity of biologicals

Biosimilars/Research | Posted 25/05/2012

This article discusses the issue of immunogenicity with respect to originator biologicals and biosimilars [1].

US Supreme Court looks set to challenge Affordable Care Act

Biosimilars/General | Posted 18/05/2012

The United States Supreme Court is reviewing the constitutionality of the provision in the Affordable Care Act providing that individuals should take personal responsibility for paying for their health care by obtaining health insurance or pay a fine. The move could mean that the Supreme Court rejects the whole healthcare law, including the biosimilars pathway created by the healthcare reform.

Biosimilars approved and marketed in Belgium

Biosimilars/General | Posted 18/05/2012

Last updated: 18 May 2012

The Federal Agency for Medicines and Health Products (FAMHP), formerly the Directorate-General for Medicinal Products of the Federal Public Service (FPS) Public Health, created in January 2007, is the official authority for medicines and health products in Belgium and is also responsible for authorising biosimilars in Belgium [1]. This is carried out via the EU procedures (centralised, national, mutual recognition or decentralised) and following EMA guidelines for biosimilars.

Daiichi Sankyo and Coherus BioSciences make biosimilars deal

Biosimilars/News | Posted 18/05/2012

Coherus BioSciences and Daiichi Sankyo announced on 7 May 2012 that the two companies had made an exclusive agreement to develop and commercialise biosimilars of etanercept and rituximab in certain Asian countries including Japan.