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Biosimilars/News

Biocon and Mylan join forces in biosimilars

Biosimilars/News | Posted 04/09/2009

Strong growth prospects for the global biosimilars space over the next decade are bringing together the world's third-largest US-based generic drugmaker Mylan and Biocon, India's second-largest biotech company.

US: Biotech drugs need only seven years protection

Biosimilars/News | Posted 04/09/2009

Biological drugs should be subject to generic competition in the US after seven years, the Obama administration said, calling it a ‘generous compromise’. Brand-name companies have lobbied for 12 to 14 years of exclusivity, while Mr Waxman proposed only five. As reported by Bloomberg News, access to cheaper copies of medicines made by biotechnology companies is ‘a key element’ in reducing healthcare costs, White House officials said in a letter to Representative Henry Waxman. “Lengthy periods of exclusivity will harm patients by diminishing innovation and unnecessarily delaying access to affordable drugs,” it said.

KBI BioPharma starts US PER.C6 cell line generation service

Biosimilars/News | Posted 04/09/2009

US contract services firm KBI Biopharma announced on 25 June 2009 that it has started using the PER.C6 platform for cell line generation as part of its offering to meet growing demand for biomanufacturing services, whether they are to produce biologicals, biosimilars or vaccines.

US Federal Trade Commission issues report on biosimilars

Biosimilars/News | Posted 05/08/2009

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

Biosimilars/News | Posted 29/07/2009

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

Biosimilars/News | Posted 31/08/2009

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

Biosimilars/News | Posted 30/07/2009

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

Biosimilars/News | Posted 05/08/2009

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

Biosimilars/News | Posted 05/08/2009

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

Biosimilars/News | Posted 30/07/2009

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

Biosimilars/News | Posted 31/08/2009

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

Biosimilars/News | Posted 06/07/2009

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

Biosimilars/News | Posted 30/07/2009

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%.

Third US biosimilars bill introduced: five years market exclusivity with user fee

Biosimilars/News | Posted 30/07/2009

On 26 March 2009 a third biosimilars bill was introduced in the US by Senators Chuck Schumer, Sherrod Brown, Jeanne Shaheen and Debbie Stabenow, Susan Collins, Mel Martinez and David Vitter. The bipartisan plan would give branded biologicals five years of market exclusivity, up to an additional three years to cover modifications, claiming this will give patients quicker access to cheaper drugs.

Biosimilars as effective and safe as expensive biologicals

Biosimilars/News | Posted 29/07/2009

Just like generic medicines, biosimilars could substantially reduce healthcare costs. Yet it seems that among physicians, pharmacists and patients there exists resistance against these cheaper versions of biotechnological medicines.

US biosimilars bill with competition after just five years

Biosimilars/News | Posted 29/07/2009

On 11 March 2009, Henry Waxman, Frank Pallone, Nathan Deal, and Jo Ann Emerson, all members of the US House Committee on Energy and Commerce, introduced the Promoting Innovation and Access to Life-Saving Medicine Act (bipartisan bill HR 1427), to allow the US FDA to approve affordable ‘biosimilar’ copies of biotech drugs or ‘biologicals’.

Waxman: US biosimilars market opens this year

Biosimilars/News | Posted 06/07/2009

“Seeing a pathway for biological generics is one of my highest priorities this year,” US Congressman Henry Waxman said via a video link to the World Generics Medicines Congress Europe 2009, held in London, UK, in February.