Biosimilars
Merck KGaA and Dr Reddy’s to collaborate on biosimilar mAbs
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
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
FDA, in its draft guidance for biosimilars, has said that biosimilars can use different drug delivery devices than the corresponding reference product.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
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
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
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
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
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
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.
Biosimilar filgrastim provides cost savings for treating febrile neutropenia
Professor Aapro and co-authors have performed a cost-efficiency analysis for the three most common granulocyte colony-stimulating factors (G-CSF) products used to treat febrile neutropenia: filgrastim (Neupogen, Amgen) and its biosimilar (Zarzio, Sandoz/Novartis) and the pegylated form of filgrastim, pegfilgrastim (Neulasta, Amgen) [1]. Filgrastim is more cost-efficient than pegfilgrastim for up to 12 days of treatment: beyond 12 days, pegfilgrastim becomes the most cost-efficient of the two. But above all, biosimilar filgrastim is the most cost saving compared to both originator filgrastim and pegfilgrastim.
