Biosimilars

Sandoz comments on EMA’s new draft biosimilars guidance

Biosimilars/News | Posted 21/06/2013

Sandoz, the generic drug division of Swiss drug giant Novartis, is pleased that the European Medicines Agency (EMA) has issued a draft revised guideline on non-clinical and clinical issues in biosimilar product development.

Call for clarity in FDA’s draft guidance on biosimilar meetings

Biosimilars/General | Posted 14/06/2013

Drug companies have made comments on FDA’s draft guidance for industry on formal meetings between the agency and biosimilars manufacturers. They believe that the guidance needs some revision to protect data and provide clarity.

Use of G-CSF biosimilars for reduction of fever

Biosimilars/Research | Posted 14/06/2013

The American Society of Hematology, the British Society of Haematology, the European Society of Hematology and the European Group of Bone Marrow Transplantation all recommend the use of granulocyte colony-stimulating factor (G-CSF) after transplant in order to reduce the time to neutrophil recovery and the number of days with fever.

Trials to start for biosimilar infliximab and etanercept

Biosimilars/News | Posted 14/06/2013

Pfizer is to start a phase I study for its biosimilar infliximab candidate (PF-06438179) and Samsung Bioepis has initiated a phase III clinical trial for its biosimilar etanercept (SB4), according to entries on the US and EU clinical trials websites.

Positive post-marketing data for biosimilar epoetin

Biosimilars/Research | Posted 07/06/2013

Injectable generics specialist, Hospira, presented results from a post-marketing study of the company’s European biosimilar epoetin (Retacrit) on 3 June 2013 at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) held in Chicago, USA.

Celltrion applies for Korean approval of biosimilar trastuzumab

Biosimilars/News | Posted 07/06/2013

On 4 June 2013, South Korean biotechnology company Celltrion announced that it had filed for approval of its biosimilar candidate CT-P6 with the Korean Ministry of Food and Drug Safety (MFDS, formerly the Korea Food and Drug Administration).

Use of G-CSF biosimilars for stem cell mobilization in autologous transplantation

Biosimilars/Research | Posted 07/06/2013

The first biosimilar granulocyte colony-stimulating factor (G-CSF) was licensed by EMA in 2008, and there are currently six biosimilar G-CSF products licensed for use in the EU [1]. All of these biosimilars are also approved for haematopoietic stem cell transplantation.

Biologicals sales have almost doubled since 2006

Biosimilars/General | Posted 07/06/2013

Sales of biologicals have almost doubled from US$63.8 billion in 2006 to US$124.6 billion in 2012.

Biopharmaceutical products in Iran

Biosimilars/Research | Posted 31/05/2013

Iran will become a leader in biotechnology products (especially copied biopharmaceuticals [1]) in Asia over the next three years, according to a review by Mahboudi et al. [2].

Russia to harmonize biologicals regulations

Biosimilars/News | Posted 31/05/2013

International regulatory bodies and the drug industry met in Moscow on 15 May 2013 to discuss how to harmonize Russia’s regulatory standards for biologicals with the rest of the world to develop a framework for pharma companies developing biologicals and biosimilars in Russia.

Biosimilars and US exclusivity

Biosimilars/General | Posted 24/05/2013

Currently, the legal pathway in the US for the approval of biosimilars is the Biologics Price Competition and Innovation Act (BPCI Act) of 2009.

Sandoz to start phase III etanercept trial

Biosimilars/News | Posted 24/05/2013

Sandoz, the generic drug division of Swiss drug giant Novartis, is to start a phase III clinical trial for a biosimilar version of etanercept in patients suffering from psoriasis, according to the EU Clinical Trials Register.

Use of G-CSF biosimilars for stem cell mobilization in healthy donors

Biosimilars/Research | Posted 24/05/2013

Granulocyte colony-stimulating factor (G-CSF) can be used to mobilize peripheral blood stem cells (PBSCs) in healthy donors. Over the last 10 years, the procedure has become the preferred option for donors compared to the donation of bone marrow.

Huahai and Oncobiologics make biosimilars deal

Biosimilars/News | Posted 24/05/2013

US-based Oncobiologics announced on 8 May 2013 that it had signed an alliance agreement for the development, manufacture and commercialization of biosimilar monoclonal antibodies with Zhejiang Huahai Pharmaceutical (Huahai).

Agila Biotech and Pfenex make biosimilars deal

Biosimilars/News | Posted 17/05/2013

Agila Biotech, a subsidiary of India-based Strides Arcolab, and US-based biotech firm Pfenex announced on 16 April 2013 that they had entered into a joint venture for biosimilars.

Sanofi starts biosimilar insulin trials

Biosimilars/News | Posted 10/05/2013

Pharma giant Sanofi confirmed in its 2013 Q1 business report that its biosimilar insulin projects have entered into phase I of clinical development as planned. Sanofi intends to develop these insulin products in order to further enlarge the Sanofi diabetes portfolio and better serve the needs of people with diabetes.

Intas launches rituximab ‘similar biologic’ in India

Biosimilars/News | Posted 10/05/2013

India-based generics company Intas Pharmaceuticals (Intas) announced the launch of a ‘similar biologic’ – as the Indian regulatory authorities call these products –version of rituximab in India.

Development of biosimilars for rheumatology

Biosimilars/Research | Posted 03/05/2013

In 2012, worldwide sales for the top three selling tumour necrosis factor (TNF) inhibitors reached US$20 billion. These biological treatments for arthritis are costing patients between US$10,000–US$30,000 per year making the need for lower cost biosimilars clear [1].

Sandoz applies for Japanese approval for biosimilar G-CSF

Biosimilars/News | Posted 03/05/2013

Novartis generics unit Sandoz announced on 25 April 2013 that it has filed an application with the Japanese health authority – Pharmaceuticals and Medical Devices Agency (PMDA) – for marketing authorization of EP2006, a biosimilar version of recombinant human granulocyte colony-stimulating factor (G-CSF).

Biosimilars agreements for Hospira and mAbxience

Biosimilars/News | Posted 03/05/2013

In line with Hospira’s strategy of expansion into biosimilars, the injectable generics specialist announced on 29 April 2013 that it had entered into a collaborative arrangement for several biosimilar products with NovaQuest Co-Investment Fund I, L.P. (NovaQuest).