Biosimilars

Small molecule versus biological drugs

Biological drugs are large and complex, often consisting of heterogeneous mixtures. They are generally made in genetically engineered cells that impose their own variabilities–in post-translation modifications such as glycosylation–on the processes used to make such drugs.

Amgen welcomes biosimilar monoclonal antibody guideline

In a statement issued on 18 June 2012, biologicals major Amgen announced that the company broadly supports the scientific principles behind the guideline on non-clinical and clinical aspects for biosimilar monoclonal antibodies recently issued by EMA [1]. The company added that the guideline aims at maintaining a high standard for approval of a biosimilar in the EU.

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FDA, in its draft guidance for biosimilars, has said that biosimilars can use different drug delivery devices than the corresponding reference product.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