Biosimilars
Trials of biosimilar monoclonal antibody prove biosimilarity
South Korean biotechnology company Celltrion presented the PLANET clinical studies results of phase I and phase III trials for its first monoclonal antibody biosimilar (CT-P13) of Johnson & Johnson’s rheumatoid arthritis blockbuster Remicade (infliximab) at the Annual Congress of the European League Against Rheumatism (EULAR) held in Berlin, Germany, on 6–9 June 2012. The results demonstrated the biosimilarity of CT-P13 to the reference drug, supporting the company’s intention to launch the biosimilar monoclonal antibody globally.
Successful phase III trial of biosimilar r-FSH
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
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FDA, in its draft guidance for biosimilars, has said that biosimilars can use different drug delivery devices than the corresponding reference product.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.
