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Production of 24 biogeneric products in Iran by 2012

Biosimilars/News | Posted 03/02/2012

According to reports on Iran’s English-language television network, Press TV, Iran is making significant advances in biogeneric products and biotechnology drugs and is planning to start the production of 24 additional biogeneric products drugs by the end of 2012.

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Amgen’s response to biosimilar substitution legislation in US

Biosimilars/News | Posted 22/02/2013

Amgen, in a statement issued on 1 February 2013, has hit back at accusations that the biotech giant is attempting to limit the uptake of biosimilars in the US by backing state bills, which constrain the use of biosimilars.

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Merck makes biosimilars deal with Samsung Bioepis

Biosimilars/News | Posted 22/02/2013

Pharma Giant Merck announced on 20 February 2013 that it had made a deal to develop and commercialize biosimilars with Samsung Bioepis.

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AMAC and GPhA hit back at Big Pharma over biosimilars

Biosimilars/News | Posted 15/02/2013

The Association of Mature American Citizens (AMAC) and the Generic Pharmaceutical Association (GPhA) have reacted strongly to the actions by Amgen and Genentech, which aim to make it more difficult for patients to get access to biosimilar medicines [1].

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Biotech firms try to limit biosimilar substitution in US

Biosimilars/News | Posted 08/02/2013

FDA is still to approve a biosimilar and has yet to issue final guidelines outlining the regulatory requirements for approval of a biosimilar in the US.

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China-based Innovent gains funding for expansion

Biosimilars/News | Posted 07/12/2012

Innovent Biologics (Innovent) has raised US$25 million in Series B financing to put towards the continued expansion of its pipeline and manufacturing capabilities.

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Finox submits r-FSH biosimilar application to EMA

Biosimilars/News | Posted 18/01/2013

Finox Biotech announced on 20 December 2012 that it had submitted a Marketing Authorisation Application (MAA) for its biosimilar recombinant follicle stimulating hormone (r-FSH) to EMA on 30 October 2012.

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ProCognia completes global glycoanalysis centre

Biosimilars/News | Posted 24/01/2013

Israeli biotech company ProCognia announced on 14 January 2013 the completion of its global centre of excellence for glycoanalytics.

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Biosimilar trastuzumab made in tobacco plants

Biosimilars/News | Posted 18/01/2013

Canada-based PlantForm have altered tobacco plants to create a biosimilar version of Roche’s breast cancer drug Herceptin (trastuzumab).

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CCM and Biocon make biosimilar insulin deal

Biosimilars/News | Posted 11/01/2013

Malaysia-based Chemical Company of Malaysia Berhad (CCM), announced on 14 December 2012 an agreement between its subsidiary, CCM Pharmaceuticals Sdn Bhd (CCMP), and India-based Biocon, giving CCMP exclusive licence and distribution rights to market, sell and distribute a range of insulin products in Malaysia and Brunei.

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Marvel withdraws biosimilar insulin applications

Biosimilars/News | Posted 07/12/2012

EMA announced on 27 November 2012 that it had been informed by Marvel LifeSciences (Marvel) that the company would be withdrawing its authorization applications for its three biosimilar human insulins.

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Approval of first biosimilar G-CSF in Japan

Biosimilars/News | Posted 30/11/2012

Mochida Pharmaceuticals (Mochida) and development partner Fuji Pharma announced on 21 November 2012 that they had gained approval for the first biosimilar granulocyte colony-stimulating factor (G-CSF) in Japan.

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Reliance Life Sciences starts ‘similar’ infliximab trial in India

Biosimilars/News | Posted 26/10/2012

Reliance Life Sciences is starting a clinical trial for a ‘similar biologic’ version of infliximab in patients suffering with rheumatoid arthritis in India.

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STC Biologics receives US$2.5 million for biosimilar mAb development

Biosimilars/News | Posted 26/10/2012

US-based biotechnology company STC Biologics announced on 10 October 2012 that it had entered into a US$2.5 million phase II Small Business Innovation Research (SBIR) contract with the National Cancer Institute (NCI) to develop a STC101, a biosimilar monoclonal antibody (mAb), for the treatment of cancer.

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Samsung halts biosimilar rituximab development

Biosimilars/News | Posted 19/10/2012

South Korean electronics giant Samsung has halted clinical development for the biosimilar version (SAIT101) of Roche’s Rituxan/MabThera (rituximab).

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TNF copy biological approved in China

Biosimilars/News | Posted 20/05/2011

China-based Simcere Pharmaceutical Group (Simcere) announced on 9 May 2011 that Shanghai Celgen Bio-Pharmaceutical (Shanghai Celgen) has received approval for Qiangke – a copy biological version of etanercept – by the Chinese authorities.

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Brazil to manufacture follow-on adalimumab

Biosimilars/News | Posted 13/05/2011

The Brazilian Ministry of Health (Ministério da Saúde) announced on 5 April 2011 that it would be entering into an agreement with PharmaPraxis to manufacture a biosimilar, or follow-on version, of Abbott’s monoclonal antibody Humira (adalimumab).

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Medicago and Cellectis in successful biosimilars research collaboration

Biosimilars/News | Posted 19/10/2012

Canadian biopharmaceutical company Medicago and Cellectis plant sciences, a subsidiary of Cellectis SA, French genome engineering specialist, announced on 4 October 2012 the successful completion of the first step in their research collaboration to improve therapeutic proteins produced in tobacco plants.

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Teva halts phase III biosimilar rituximab trial

Biosimilars/News | Posted 12/10/2012

Israeli generics giant Teva Pharmaceutical Industries (Teva) has suspended its phase III trial of its biosimilar version (TL011) of Roche’s Rituxan/MabThera (rituximab).

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EMA receives second application for biosimilar infliximab

Biosimilars/News | Posted 05/10/2012

According to EMA’s list of applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use released in September 2012, the agency will be reviewing a second application for a biosimilar version of infliximab.