Biosimilars

Biosimilar G-CSF prescribed more than originator

Biosimilars/News | Posted 02/08/2013

Sandoz, the generic drug division of Swiss drug giant Novartis, announced on 22 July 2013 that its biosimilar granulocyte colony-stimulating factor (G-CSF) Zarzio (filgrastim) has overtaken the originator product in terms of prescriptions.

Regulation of similar biotherapeutic products in Latin America

Biosimilars/Research | Posted 02/08/2013

Regulation of similar biotherapeutic products (SBPs) in Latin America varies widely among different countries and, although many countries have yet to introduce guidance for biosimilars, the region is moving towards increasing standards of regulation for these products [1, 2].

EMA approves first monoclonal antibody biosimilar

Biosimilars/News | Posted 05/07/2013

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) announced on 28 June 2013 that it had recommended granting of marketing authorization for the first monoclonal antibody biosimilar, marketed under two trade names, Remsima (Celltrion) and Inflectra (Hospira) with different marketing authorization, different EPAR, and different packaging.

Biosimilars applications under review by EMA – 2013 Q2

Biosimilars/General | Posted 05/07/2013

Last update: 15 October 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.

Infliximab biosimilar comparable to Remicade

Biosimilars/Research | Posted 28/06/2013

South Korean biotechnology company Celltrion presented results of its extended trials for its biosimilar infliximab candidate Remsima (CT-P13) at the European League Against Rheumatism (EULAR) 2013 Conference, which was held in Madrid, Spain on 12–15 June 2013.

Erythropoietin biosimilars in bone marrow transplantation and stem cell donation

Biosimilars/Research | Posted 28/06/2013

Combination therapy with granulocyte colony-stimulating factor (G-CSF) and erythropoietin (EPO) has been used with the aim of accelerating the recovery of red blood cells following autologous bone marrow transplantation [1]. Previous studies have shown, however, that this practice has no significant effect on erythroid recovery and transfusional requirements.

Robust data for biosimilar trastuzumab programmes presented

Biosimilars/Research | Posted 21/06/2013

Celltrion and Pfizer have presented robust data from their respective biosimilar trastuzumab programmes at the ASCO (American Society of Clinical Oncology) 2013 Annual Meeting held on 31 May to 4 June 2013.

Pfizer to start trial for biosimilar adalimumab

Biosimilars/News | Posted 21/06/2013

Pharma giant Pfizer is once again expanding its pipeline of biosimilars and is set to start a phase I study for its biosimilar adalimumab candidate (PF-06410293) according to ClinicalTrials.gov, the US clinical trials website.

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.