Biosimilars

Failed biosimilars company to be sold

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

EC approves first monoclonal antibody biosimilar

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.

Celltrion applies for biosimilar infliximab approval in Japan

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).

Positive phase III data for Epirus infliximab biosimilar

US-based Epirus Biopharmaceuticals (Epirus) announced on 28 August 2013 that its biosimilar infliximab candidate had demonstrated ‘clinical comparability’ to Remicade as measured by the ACR20 response in severe rheumatoid arthritis patients.

Biocad signs deal for biosimilar darbepoetin alpha in Turkey

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).

Baxter and Coherus to collaborate on biosimilars

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

Biosimilar manufacturers fail to compete in Italy

In the current global economic crisis, significant savings on healthcare spending should be made as a result of increased competition between manufacturers of off-patent biologicals or biosimilars. If only that were so, writes Professor Livio Garattini at the Centre for Health Economics, Ranica, Italy [1], who has analysed the pricing of off-patent biologicals in Italy, a country particularly hard hit by the economic downturn.

Roche abandons Herceptin patent in India

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

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

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

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.

Assessment of efficacy and safety of biosimilars in rheumatology

During the last decade, the availability of biological therapies has revolutionized the treatment of rheumatoid arthritis. Biologicals, unlike small-molecule chemical drugs, are extremely complex molecules, making producing biosimilars far from a simple process.

AstraZeneca pursuing biosimilars with Celltrion bid

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

Cost savings from use of biosimilars in rheumatology

The treatment of rheumatoid arthritis provides a clear argument in favour of developing biosimilars and the need to collect sufficient pharmacological data to validate their bioequivalence and interchangeability.

Teva and Lonza end biosimilars agreement

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Biopharmaceutical products in Iran

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

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

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

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

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

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

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

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.