Biosimilars
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FDA, in its draft guidance for biosimilars, has said that biosimilars can use different drug delivery devices than the corresponding reference product.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.
Also noted on biosimilars: 11 May 2012
Sandoz testimony at FDA hearing on biosimilars will emphasise need for consistent regulatory standards across all biologicals
Sandoz announced on 9 May 2012 that Dr Mark McCamish, Head of Global Biopharmaceutical Development, would present on behalf of the Novartis Group of companies (Novartis) at the 11 May 2012 FDA public hearing on draft guidances for biosimilars.
The message he will convey will focus on the need for a single science-based regulatory standard that FDA should apply across all biologicals, irrespective of the business model of the sponsor. As well as a single standard, Dr McCamish will address the points that biosimilar clinical studies should be only confirmatory and the fact that interchangeability is critical to maximising access to affordable biosimilars for US patients.
Source: Sandoz
Bayer opposes sorafenib compulsory licence in India
German pharma giant Bayer told Reuters on 5 May 2012 it had challenged a decision by the Indian Government, which allows India-based generics firm Natco Pharma to sell a generic version of Bayer’s liver and kidney cancer drug Nexavar (sorafenib) in India, before its patent expires in 2020.
