Biosimilars/News

Stada in-licenses biosimilar filgrastim

Biosimilars/News | Posted 08/11/2013

German generics giant Stada Arzneimittel (Stada) announced on 28 October 2013 that it was strengthening its activities in the biosimilars area by in-licensing a biosimilar filgrastim product from Canada-based Apotex.

EC approves first monoclonal antibody biosimilar

Biosimilars/News | Posted 13/09/2013

Hospira announced on 10 September 2013 that it had received European Commission (EC) approval for its biosimilar monoclonal antibody infliximab (Inflectra), a first in Europe.

Biocad signs deal for biosimilar darbepoetin alpha in Turkey

Biosimilars/News | Posted 06/09/2013

Russian biosimilars manufacturer Biocad has signed a definitive agreement with Turkish oncology specialist Koçak Farma for the export of biosimilar darbepoetin alpha active pharmaceutical ingredients (APIs).

Amgen to start phase III trial for biosimilar adalimumab

Biosimilars/News | Posted 27/09/2013

Biotechnology giant Amgen is to start a phase III clinical trial for a biosimilar version of adalimumab in patients suffering from severe rheumatoid arthritis according to the EU Clinical Trials Register.

EMA approves biosimilar follitropin alfa and somatropin

Biosimilars/News | Posted 20/09/2013

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) announced on 31July 2013 that it had recommended granting of marketing authorization for a biosimilar follitropin alfa. While on 9 September 2013, the agency announced the approval of a new somatropin biosimilar.

Failed biosimilars company to be sold

Biosimilars/News | Posted 20/09/2013

The assets of biosimilars developer Elona Biotechnologies (Elona) will be auctioned on 27 September 2013 unless sold before 6 September 2013.

Celltrion applies for biosimilar infliximab approval in Japan

Biosimilars/News | Posted 13/09/2013

On 11 September 2013, South Korean biotechnology company Celltrion announced that it had filed for approval of Remsima, its biosimilar infliximab monoclonal antibody, with Japan’s Ministry of Health, Labour and Welfare (MHLW).

Baxter and Coherus to collaborate on biosimilars

Biosimilars/News | Posted 06/09/2013

Baxter International (Baxter) has made another agreement for biosimilars, this time with fledgling biotech company Coherus Biosciences (Coherus).

Roche abandons Herceptin patent in India

Biosimilars/News | Posted 30/08/2013

Swiss-based pharma giant Roche has decided not to pursue its patent for its blockbuster cancer drug Herceptin (trastuzumab) in India, opening the market to biosimilars.

Indian firms chasing ‘similar biologic’ Herceptin

Biosimilars/News | Posted 30/08/2013

Following the decision by Swiss-based pharma giant Roche not to pursue its patent for Herceptin (trastuzumab) in India [1] it seems that a whole host of Indian firms are lining up to get their ‘similar biologic’ of the blockbuster cancer drug to market.

Apotex breaking into the North American and European G-CSF markets

Biosimilars/News | Posted 23/08/2013

A new biosimilar filgrastim is poised to enter the important granulocyte colony-stimulating factor (G-CSF) market following a positive opinion from the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP).

EMA approval for Teva’s long-acting recombinant G-CSF

Biosimilars/News | Posted 23/08/2013

The European Medicines Agency (EMA) has granted marketing authorization for a new long-acting filgrastim – Lonquex (XM22 lipegfilgrastim) – to prevent chemotherapy-induced neutropenia in cancer patients.

AstraZeneca pursuing biosimilars with Celltrion bid

Biosimilars/News | Posted 16/08/2013

Pharma giant AstraZeneca is rumoured to be ready to join the race for biosimilars with a bid for South Korean biotechnology company Celltrion.

Teva and Lonza end biosimilars agreement

Biosimilars/News | Posted 09/08/2013

Despite Switzerland-based API producer Lonza denying reports back in April 2013 that it was considering backing out of its biosimilars joint venture with Israeli generics giant Teva Pharmaceutical Industries (Teva) that is just what has happened.

EMA reviewing biosimilar insulin application

Biosimilars/News | Posted 02/08/2013

According to EMA’s list of applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use released on 4 July 2013 the agency is now reviewing a new application for a biosimilar insulin product.

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.

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.

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