Home / Biosimilars / News

News

US Federal Trade Commission issues report on biosimilars

The US Federal Trade Commission (FTC) released a report entitled Follow-on Biologic Drug Competition, which examines whether the price of biological drugs could be reduced by competition from so-called ‘follow-on biologics’ (FOBs) or biosimilars.

Views on biosimilars: Genentech

Genentech has put a clear position on biosimilars on its website. The company explains that the terms ‘biosimilar’ or ‘follow-on biologic’ refer to products that are marketed after expiration of patents, which are claimed to have similar properties to existing biological products. Due to the complexity of biologicals, a product can only be made that is similar, but not identical.

BIO wants to delay biodissimilars as long as possible

Biotech drugs are big revenue earners. Their sales growth rate may have slipped back into single figures last year, but according to IMS Health data they still accounted for more than 37% of the growth in the US pharmaceutical market last year, with revenues of around US$85 billion (Euros 60.8 billion), and biotech stands to take an even larger share of the market in future.

Biosimilar substitution: Listen to all lobbyists

In December 2007 a British parliamentary review was conducted on the issue of biosimilars. At a British meeting it was told that “automatic substitution rules do not apply to biologicals.” The recommendation of the panel was that “there should be an urgent ban on the substitution of biopharmaceuticals in the UK until effective safeguards can be relied upon.”

High yields and human-like glycosylation with DSM’s technology

DSM says that studies done at its R & D laboratories in Groningen, The Netherlands, show that its extreme density (XD) technology boosts bioreactor productivity and titers of mammalian cell culture processes for protein and antibody production. The studies show that the yields from Chinese hamster ovary cell cultures can be increased 5-10 fold over their previous fed-batch processes using only off the shelf, commercially available media.

New expression systems create competitive advantage

New, alternative expression systems in various stages of development are showing their viability in large-scale protein manufacture. The economics and increased simplicity of these new platforms make them better alternatives to the currently dominant E. coli, yeast and CHO systems.

Indian Reliance Life Sciences to launch four more biosimilars by next year

Reliance Life Sciences, based in Mumbai, India, announced on 29 March 2009 in the Indian Business Standard that it will launch four biosimilars by next year.

Obama wants to introduce US biosimilars pathway

US President Barack Obama plans to fund part of his healthcare reform plans by backing an approval pathway for generic biologicals. As reported by Christopher Spillane in Scrip News, Mr Obama lobbied the American Medical Association to support proposals to overhaul US healthcare in a far-reaching address.

Second US biosimilars bill introduced: 12 instead of five years market exclusivity

On 17 March 2009, US Congresswoman Anna Eshoo (Democrat of California, USA) introduced a second biosimilars bill in the House that will compete with the bill introduced a week ago by US Congressman Henry Waxman, Chairman of the House Energy and Commerce Committee. Both bills would create the first US approval pathway for follow-on biologics. The bills differ in areas such as length of exclusivity for innovators and the need for guidance documents.

Indian firms may well take large slice of global biosimilars pie

Since the Indian government announced that it wants to make almost US$70 million (Euros 49.7 million) in funding available for the development of biosimilar medicines, Indian generics firms adapt their strategies and plan to go abroad. The proposed US$68 million (Euros 48.3 million) in funding just announced by India's Department of Biotechnology would be offered through the Biotech Industry Partnership Programme, with soft loans being available for biosimilar development at an interest rate of about 2%.