Biosimilars

Marvel withdraws biosimilar insulin applications

Biosimilars/News | Posted 07/12/2012

EMA announced on 27 November 2012 that it had been informed by Marvel LifeSciences (Marvel) that the company would be withdrawing its authorization applications for its three biosimilar human insulins.

Approval of first biosimilar G-CSF in Japan

Biosimilars/News | Posted 30/11/2012

Mochida Pharmaceuticals (Mochida) and development partner Fuji Pharma announced on 21 November 2012 that they had gained approval for the first biosimilar granulocyte colony-stimulating factor (G-CSF) in Japan.

ASBM publishes paper on biosimilar naming

Biosimilars/General | Posted 30/11/2012

The US-based Alliance for Safe Biologic Medicines (ASBM) announced on 28 November 2012 that its recommendations with respect to identification and substitution of biosimilars have been published in the Food and Drug Law Institute (FDLI) policy forum.

Overview of research on US regulatory issues surrounding biosimilars in 2012

Biosimilars/Research | Posted 30/11/2012

Period: January to August 2012

The US is somewhat behind Europe in the biosimilars race, but has issued draft guidance and is expected to have a practical biosimilar approval pathway in place in the near future.

Competing biosimilars to Amgen’s biologicals

Biosimilars/General | Posted 30/11/2012

Amgen has been a leading biotechnology company since 1980. Amgen pioneered the development of novel products based on advances in recombinant DNA and molecular biology and launched the biotechnology industry’s first blockbuster medicines.

ABPI issues position paper on biosimilars

Biosimilars/General | Posted 23/11/2012

The Association of the British Pharmaceutical Industry (ABPI), which represents innovative research-based biopharmaceutical companies in the UK, announced on 12 November 2012 the publication of its position paper on biosimilars.

Biosimilars approved and marketed in Germany

Biosimilars/General | Posted 23/11/2012

Last updated: 23 November 2012

The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) is responsible for the approval, i.e. marketing authorization, of medicinal products, including biosimilars, in Germany.

Saving money in the European healthcare system with biosimilars

Biosimilars/Research | Posted 16/11/2012

Biotechnology-derived medicines are increasingly popular for treating a range of conditions from cancer to autoimmunity, and yet they are among the most expensive healthcare products owing to their manufacture using live cell cultures. As healthcare providers become increasingly concerned about rising costs, interest is turning to the idea of substituting reference biological drugs with cheaper but similar biological products, or biosimilars, after patents expire on reference products. The use of biosimilars has the potential to reduce healthcare expenditure, particularly for long-term treatments, which incur high annual treatment costs.

Dialogue needed to build confidence in biosimilars

Biosimilars/Research | Posted 16/11/2012

Concerns about the safety and efficacy of biosimilars have led many healthcare professionals to become reluctant to prescribe these products for their patients [1]. According to a commentary by Dr Hans C Ebbers and co-authors, these concerns could be addressed through more engagements taking place between regulatory authorities and the medical community over the drafting of regulatory guidelines [2]. This would result in greater confidence in the regulatory process and trust in the products that gain approval.

American dermatologists update position statement on biosimilar substitution

Biosimilars/General | Posted 16/11/2012

On 3 November 2012, the American Academy of Dermatology (AAD) updated its position statement on generics and biosimilar substitution to reflect its views, in particular on interchangeability* and naming of biosimilars.

Positive results from phase III study with biosimilar human insulin

Biosimilars/Research | Posted 16/11/2012

One of Asia’s leading biotechnology companies, Biocon, announced on 31 October 2012 positive results from its global phase III study for its recombinant human insulin (Insugen). The study, which was carried out in type 1 diabetes mellitus (T1DM) patients, demonstrated comparable safety and efficacy compared to the originator product.

Sandoz starts phase III US trial for biosimilar epoetin alfa

Biosimilars/Research | Posted 09/11/2012

Sandoz, the generic drug division of Swiss drug giant Novartis, announced on 25 October 2012 that it had started patient enrolment in a phase III clinical trial in the US for biosimilar epoetin alfa (Amgen/Johnson & Johnson’s Epogen/Procrit).

The latest biosimilars agreements

Biosimilars/News | Posted 09/11/2012

Biosimilar is still the hottest subject around. Just a few of the latest collaborations for the development of biosimilars include agreements made on 6 November 2012 between AET BioTech and BioXpress Therapeutics; Oncobiologics and Boston Oncology; ProCognia and UniTargetingResearch; and the Innovent Biologics and Pharmatech Associates agreement made on 1 November 2012.

Japanese firms developing biosimilars

Biosimilars/News | Posted 09/11/2012

Japanese firms are definitely not dragging their heels when it comes to biosimilars. The latest agreement for biosimilar development involves LG Life Sciences (LGLS) and Mochida Pharmaceutical (Mochida), while joint venture Fujifilm Kyowa Kirin Biologics has announced it is to initiate development of a biosimilar version of bevacizumab.

Biosimilar terminology confusion

Biosimilars/Research | Posted 26/10/2012

Imprecise usage of the term biosimilar in the literature is an issue that has already been highlighted by EMA [1].

Glossary of key terms

Biosimilars/General | Posted 26/10/2012

Last update: 9 June 2017

Confusion may sometimes surround terms used in the fields of generics and biosimilars. This has been recognized as a problem by EMA, who has expressed the need to propose a more precise definition for biosimilars due to problems arising from imprecise usage of the terms in the scientific literature and elsewhere [1].

Reliance Life Sciences starts ‘similar’ infliximab trial in India

Biosimilars/News | Posted 26/10/2012

Reliance Life Sciences is starting a clinical trial for a ‘similar biologic’ version of infliximab in patients suffering with rheumatoid arthritis in India.

STC Biologics receives US$2.5 million for biosimilar mAb development

Biosimilars/News | Posted 26/10/2012

US-based biotechnology company STC Biologics announced on 10 October 2012 that it had entered into a US$2.5 million phase II Small Business Innovation Research (SBIR) contract with the National Cancer Institute (NCI) to develop a STC101, a biosimilar monoclonal antibody (mAb), for the treatment of cancer.

Samsung halts biosimilar rituximab development

Biosimilars/News | Posted 19/10/2012

South Korean electronics giant Samsung has halted clinical development for the biosimilar version (SAIT101) of Roche’s Rituxan/MabThera (rituximab).

Pfizer carrying out biosimilar trastuzumab trial in US

Biosimilars/Research | Posted 19/10/2012

Pharma giant Pfizer is carrying out a phase I trial in the US for a biosimilar version of trastuzumab.