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Biosimilars

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US FDA prepares for biosimilars in 2011 budget plan, despite stalled healthcare reform bill

Biosimilars/News | Posted 03/03/2010

Increasing inspections and creating a regulatory pathway for the approval of biosimilars are among the most important areas of the US FDA's fiscal 2011 budget request, US Department of Health and Human Services (HHS) Secretary Ms Kathleen Sebelius says. In testimony before the House Energy and Commerce Committee on 4 February 2010, Ms Sebelius focused on funds included in the budget request for the FDA's efforts to improve medical product safety, including increased inspections and investment in tools to enhance the safety of increasingly complex drugs and biologics.

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Bionomics of biosimilars - Indian options for investors

Biosimilars/General | Posted 02/03/2010

As reported by Ms Nayantara Som in BioSpectrumIndia of 13 January 2010, biosimilars are said to be the next big cash cow for India. However, players have many knots to untangle before they can have a firm grip over the economics of the market.

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Bionomics of biosimilars – EU and US markets not easy for India

Biosimilars/General | Posted 02/03/2010

As reported by Ms Nayantara Som in BioSpectrumIndia of 13 January 2010, biosimilars are said to be the next big cash cow for India. However, players have many knots to untangle before they can have a firm grip over the economics of the market, she warns.

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Bionomics of biosimilars – Indian opportunities

Biosimilars/General | Posted 02/03/2010

As reported by Ms Nayantara Som in BioSpectrumIndia of 13 January 2010, biosimilars are said to be the next big cash cow for India. However, players have many knots to untangle before they can have a firm grip over the economics of the market.

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Bionomics of biosimilars – India’s next big cash cow?

Biosimilars/General | Posted 02/03/2010

As reported by Ms Nayantara Som in BioSpectrumIndia of 13 January 2010, biosimilars are said to be the next big cash cow for India. According to her, however, players have many knots to untangle before they can have a firm grip over the economics of the market.

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FDA accepts Teva’s biosimilar filgrastim BLA, Amgen not

Biosimilars/News | Posted 26/02/2010

The US FDA has accepted Teva‘s application to sell a biosimilar version of Amgen's Neupogen (filgrastim), although the biotech giant is working to block the move in court.

XM02, a granulocyte colony-stimulating factor (G-CSF), is designed to treat severe neutropenia, a haematological disorder characterised by an abnormally low number of white blood cells. If approved, the drug would be marketed under the name Neutroval by US pharma company Hospira, which in 2009 acquired worldwide rights to the new version in a deal that also saw it gain manufacturing capacity for filgrastim and pegfilgrastim - a long-acting version of the drug marketed by Amgen as Neulasta. The worldwide market for Neulasta and Neupogen currently stands at more than US$2 billion.

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Abbott: Non-responding RA patients with anti-infliximab antibodies may switch to less immunogenic anti-TNF

Biosimilars/Research | Posted 22/02/2010

In the race for biosimilar/biobetter monoclonal antibodies (MAbs), it is interesting to compare originator MAbs, e.g. mouse-human chimeric infliximab (Remicade) of Johnson & Johnson’s Centocor versus Abbott’s fully human – and thus less immunogenic – adalimumab (HUMIRA).

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Celtic Pharma invests in Cantab, PolyTherics for ‘biosuperiors’

Biosimilars/News | Posted 19/02/2010

As reported by Genetic Engineering & Biotechnology News on 25 and 26 January 2010, Celtic Pharma Holdings is making an initial £5 million (about $8.1 million) investment in Cantab Biopharmaceuticals, Cambridge, UK. Cantab is wholly owned by the Celtic Pharma Holdings II LP (CP2) fund. The new CP2 funding will be spread over three years and will support the development of the firm’s first clinical-stage so-called ‘biosuperior’ biologic in haematology.

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Korean biopharma: special programme for biosimilars

Biosimilars/News | Posted 18/02/2010

As reported by Narayan Kulkami, Singapore, in BioSpectrum Asia Edition on 18 January 2010, the Korean biopharmaceutical sector gets support for biosimilars and/or biobetters.(see also Korean biopharma gets support for biosimilars/biobetters)

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Korean biopharma gets support for biosimilars/biobetters

Biosimilars/News | Posted 18/02/2010

As reported by Narayan Kulkami, Singapore, in BioSpectrum Asia Edition on 18 January 2010, the [South] Korean biopharmaceutical industry continues to get the attention of the global players, mainly because the Korean government in 2009 identified ‘biopharmaceutical and medical equipment’ as one of the future engines for economic growth. The life sciences industry in Korea consists of close to 2000 companies including 580 pharmaceutical companies and 600 biotech companies. (see also Korean biopharma: special programme for biosimilars)