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Biosimilars/News

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US healthcare reform passed: Biosimilars Pathway in US with 12 years exclusivity for biologics

Biosimilars/News | Posted 02/04/2010

The US House of Representatives voted 219-212 on March 21 2010 to approve President Mr Barack Obama’s US$940 billion, 10-year health reform, and he could now sign the bill into law as early as 23 March 2010.

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Hospira's biosimilar filgrastim recommended for EU approval

Biosimilars/News | Posted 29/03/2010

On 18 March 2010, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorisation for Hospira’s biosimilar product Nivestim (filgrastim), 12 MU/0.2 mL, 30 MU/0.5 mL, 48 MU/0.5 mL solution for injection or infusion intended for the treatment of neutropenia.

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South Korea to emerge as global leader in biosimilar R & D

Biosimilars/News | Posted 26/03/2010

According to the South Korea Pharmaceuticals and Healthcare Report Q2 2010 released by Business Monitor International (BMI) in March 2010, South Korea will emerge as a global leader in biosimilar research and development.

AutekBio to build ‘Asia’s largest biologics contract manufacturing organisation’ in China

Biosimilars/News | Posted 19/03/2010

AutekBio, Inc. –with headquarters in the Bay Area of California, USA, but operations in China– will build one of Asia’s largest biologic contract manufacturing organisation (CMO) facilities in southern Beijing, China. To construct the facility, AutekBio signed a deal securing US$100 million in venture capital from private and government sources. Contributing to the capital raise were SUMA Ventures and Beijing E-Town Harvest International Capital Management Corporation, Beijing’s Municipal Government’s venture capital group. The new joint venture will build a world class R & D and manufacturing centre in southern Beijing, to service international biologic developments, with combined volumes of bioreactors up to 20,000 L in multiple production lines (trains).

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Modern monoclonal antibody production - focus on quality by design, timelines, cost

Biosimilars/News | Posted 09/03/2010

In the decade since severe capacity constraints limited monoclonal antibody (MAb) production, the industry has adjusted, so that today, overcapacity is the issue, along with developing techniques to ensure product quality, reduce development timelines, and decrease costs, writes Ms Gail Dutton in a Genetic Engineering & Biotechnology News Feature Article on 15 February 2010. Many of these issues will be explored at IBC’s conference on ‘Antibody Development and Production’ in March 2010 as she points out.

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How to tackle overcapacity in monoclonal antibody production

Biosimilars/News | Posted 09/03/2010

In the early days, most monoclonal antibody (MAb) therapies required high dosages, as pointed out by Ms Gail Dutton in a Genetic Engineering & Biotechnology News Feature Article on 15 February 2010 (see also Monoclonal antibodies modelling - predictive analytics, Improving monoclonal antibody production - antibody-drug conjugate technology and Modern monoclonal antibody production - focus on quality by design, timelines, cost)

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Monoclonal antibodies modelling - predictive analytics

Biosimilars/News | Posted 09/03/2010

Improved analytics is helping to ensure that the active pharmaceutical ingredient (API) quality attributes of monoclonal antibodies (MAbs) are identified as early as possible, determining both the desirable and undesirable characteristics, as pointed out by Ms Gail Dutton in a Genetic Engineering & Biotechnology News Feature Article on 15 February 2010 (see also How to tackle overcapacity in monoclonal antibody production, Improving monoclonal antibody production - antibody-drug conjugate technology and Modern monoclonal antibody production - focus on quality by design, timelines, cost)

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Improving monoclonal antibody production - antibody-drug conjugate technology

Biosimilars/News | Posted 09/03/2010

Researchers are developing new approaches to improve monoclonal antibody (MAb) production, as pointed out by Ms Gail Dutton in a Genetic Engineering & Biotechnology News Feature Article on 15 February 2010 (see also How to tackle overcapacity in monoclonal antibody production, Monoclonal antibodies modelling - predictive analytics and Modern monoclonal antibody production - focus on quality by design, timelines, cost)

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GTC achieves high-level production of TG20, a biobetter anti-CD20 MAb with enhanced antibody-dependent cell-mediated cytotoxicity

Biosimilars/News | Posted 11/03/2010

GTC Biotherapeutics announced on 1 March 2010 that it has achieved high-level production of TG20; an anti-CD20 monoclonal antibody (MAb). The TG20 MAb, which is produced in the milk of transgenic goats, is being co-developed by GTC and LFB as part of an LFB-GTC joint venture.

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Biosimilar epoetin zeta gets positive EMA-CHMP opinion for SC route in renal patients in EU

Biosimilars/News | Posted 10/03/2010

Hospira announced on 22 February 2010 that the EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended for approval the administration of Retacrit (epoetin zeta) subcutaneously in the nephrology setting. This provides an alternative option to intravenous (IV) delivery of the drug for the symptomatic treatment of anaemia associated with chronic renal failure. Final approval by the European Commission is expected in the next few months, which will result in marketing authorisation for Retacrit subcutaneous (SC) administration in all EU Member States.