Biosimilars

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).

Hospira marks five years of biosimilars

Biosimilars/News | Posted 29/04/2013

Self-proclaimed world leader in injectable drugs, Hospira, commemorated five years of providing biosimilars to the European market at the BIO International Convention in Chicago, USA, on 24 April 2013.

Celltrion stops phase III trial of biosimilar rituximab

Biosimilars/News | Posted 29/04/2013

South Korean biotechnology company Celltrion has stopped the late-stage trial of its biosimilar version of Roche’s blockbuster arthritis/non-Hodgkin’s lymphoma drug MabThera/Rituxan (rituximab).

Efficacy, Extrapolation, Interchangeability V16E25LB

Efficacy, extrapolation and interchangeability of biosimilars

Biosimilars/Research | Posted 19/04/2013

Biosimilars have been available in Europe for more than seven years; despite this fact, physicians still have concerns about the use of biosimilars. Some of their concerns have been discussed by members and experts of the Working Party on Similar Biologic Medicinal Products of the European Medicines Agency (EMA) [1].

Cipla launches first etanercept ‘similar biologic’ in India

Biosimilars/News | Posted 19/04/2013

India-based generics manufacturer Cipla announced on 17 April 2013 the launch of its ‘similar biologic’ product Etacept, the first ‘similar biologic’ of etanercept in India.

Research on clinical trial issues for biosimilars

Biosimilars/Research | Posted 19/04/2013

Period: September to December 2012

In order to demonstrate comparability between a biosimilar and its reference product, EMA recommends that the clinical trial should make it possible to detect a difference between the biosimilar and reference product. In most cases, this means that a two-arm clinical trial design (reference biological and biosimilar) in a small group of homogenous patients may be used. If the two arms of the trial produce similar results, then the biosimilar can be approved.

Quality, similarity and safety of biosimilars

Biosimilars/Research | Posted 12/04/2013

An abbreviated pathway for the approval of biosimilars was implemented in the EU in 2005. Despite biosimilars being available in Europe for more than seven years, physicians still have concerns about the use of biosimilars. Members and experts of the Working Party on Similar Biologic Medicinal Products of the European Medicines Agency (EMA) highlight what physicians need to know to make informed and appropriate treatment choices for their patients [1].

Lonza not backing out on biosimilars

Biosimilars/News | Posted 12/04/2013

Lonza has made a statement refuting reports that the Switzerland-based company was considering backing out of its biosimilars joint venture with Israeli generics giant Teva Pharmaceutical Industries (Teva).

Phase I/IIb trial of CT-P6 shows comparability to trastuzumab

Biosimilars/Research | Posted 12/04/2013

Results of a phase I/IIb trial for South Korean biotechnology company Celltrion’s biosimilar candidate CT‑P6 were presented at the 13th St Gallen International Breast Cancer Conference held in St Gallen, Switzerland, on 13–16 March 2013. The results demonstrated the comparable pharmacokinetics and safety of CT-P6 to the reference drug.

Biosimilars applications under review by EMA – 2013 Q1

Biosimilars/General | Posted 12/04/2013

Last update: 12 April 2013

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the EU. A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or ‘reference drug’.