Biosimilars

Positive phase III results for Mylan’s biosimilar pegfilgrastim

Biosimilars/Research | Posted 14/10/2016

Results of a study of Biocon and Mylan’s comparing Biocon/Mylan’s biosimilar pegfilgrastim (MYL-1401H) to the originator (Neulasta) has ‘demonstrated equivalent efficacy’, according to Mylan [1].

Court rules in favour of Apotex in biosimilars dispute

Biosimilars/General | Posted 14/10/2016

Biosimilars specialist Apobiologix, which is part of the Apotex group, announced on 9 September 2016 that it had won its battle in the US against biologicals giant Amgen with respect to its filgrastim (Grastofil) and pegfilgrastim (Lapelga) biosimilars.

EMA accepts application for trastuzumab biosimilar

Biosimilars/News | Posted 07/10/2016

Samsung Bioepis, which is a joint venture between South Korean electronics giant Samsung and biotechnology company Biogen, announced on 3 October 2016 that its regulatory submission for its proposed trastuzumab biosimilar (SB3) had been accepted for review by the European Medicines Agency (EMA). The company says the marketing application was submitted in August 2016.

Biosimilars in rheumatology

Biosimilars/Research | Posted 07/10/2016

In 2015, the rheumatology community saw the emergence of the first biosimilars onto the market. Biosimilars are not new to the medical community at large, having been on the market in the European Union (EU) since 2006. However, their arrival into the field of rheumatology is new and, according to researchers from the National Health Service (NHS) Foundation Trust and King's College London, ‘comes with great anticipation’ [1].

FDA approval for Amgen’s adalimumab biosimilar

Biosimilars/News | Posted 30/09/2016

The US Food and Drug Administration (FDA) announced on 23 September 2016 that it had approved Amgen’s biosimilar version of AbbVie’s arthritis blockbuster Humira (adalimumab).

Switching may not be suitable for patients with immunogenicity

Biosimilars/Research | Posted 30/09/2016

Results of a study of antibodies to infliximab comparing both the originator (Remicade ) and biosimilar (Inflectra/Remsima; CT-P13) versions has shown ‘cross-immunogenicity’ between the originator and biosimilar in patients with rheumatic diseases [1].

Efficacy and safety of biosimilar infliximab in children with IBD

Biosimilars/Research | Posted 30/09/2016

Researchers from Birmingham Children’s Hospital presented results from a study of the use of the infliximab biosimilar CT-P13 (Remsima/Inflectra) in children with inflammatory bowel disease (IBD) [1].

Australia says etanercept biosimilar can be substituted

Biosimilars/News | Posted 30/09/2016

Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) has decided that the etanercept biosimilar Brenzys ‘could be marked as equivalent’ to the brand-name biological Enbrel on the Australian Pharmaceutical Benefits Scheme (PBS).

Biosimilar User Fee Act reauthorization

Biosimilars/General | Posted 23/09/2016

On 16 September 2016, the US Food and Drug Administration (FDA) released the Biosimilar User Fee Act II (BsUFA II) performance goals letter, attracting support from industry associations.

FDA approves biosimilar etanercept Erelzi

Biosimilars/News | Posted 23/09/2016

The US Food and Drug Administration (FDA) announced on 30 August 2016 that it had approved Sandoz’s biosimilar version of Amgen/Pfizer’s arthritis blockbuster Enbrel (etanercept).

Positive phase III results for Sandoz etanercept biosimilar

Biosimilars/Research | Posted 23/09/2016

Results of a study of Sandoz’s etanercept biosimilar (GP2015) compared to Amgen/Pfizer’s arthritis blockbuster Enbrel (etanercept) have shown ‘equivalent efficacy’, according to the company.

Canadian approval for etanercept biosimilar

Biosimilars/News | Posted 16/09/2016

Merck Canada announced on 12 September 2016 that it had received approval for its etanercept biosimilar Brenzys (SB4) from Health Canada – the first subcutaneous anti-tumour necrosis factor (anti-TNF) biosimilar available in Canada.

Study supports interchangeability of TNF-α biosimilars

Biosimilars/Research | Posted 16/09/2016

For years, the costs of drugs have been rising. Prescription drug spending in the US rose by 12.6% in 2014 and almost 1 in 4 Americans report difficulty affording their prescriptions. A familiar situation in many countries, the escalating costs of drugs make them unaffordable for a large part of the world.

More positive phase I results for Coherus pegfilgrastim biosimilar

Biosimilars/Research | Posted 16/09/2016

US-based biosimilars developer Coherus BioSciences (Coherus) announced on 11 July 2016 that follow-on results from a phase I study of its candidate pegfilgrastim biosimilar (CHS 1701) were positive.

Mylan and Biocon submit trastuzumab biosimilar to EMA

Biosimilars/News | Posted 09/09/2016

Mylan and Biocon announced on 25 August 2016 that the regulatory submission for their proposed trastuzumab biosimilar (MYL-1401O) had been accepted for review by the European Medicines Agency (EMA).

Biosimilars for use in fertility treatment

Biosimilars/Research | Posted 09/09/2016

As patents expire on originator products, there is increasing interest in developing biosimilars globally. Authors Raoul Orvieto and David Seifer from the Sheba Medical Center and Sackler Faculty of Medicine of the Tel Aviv University in Israel investigated biosimilars used in fertility treatment [1].

Biosimilars applications under review by EMA – August 2016

Biosimilars/General | Posted 09/09/2016

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (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.

Safety and efficacy of Remsima in IBD patients in clinical practice

Biosimilars/Research | Posted 09/09/2016

Researchers from Spain presented results from a study of the use of the infliximab biosimilar Remsima in ulcerative colitis disease patients in clinical practice after six months treatment.

Use of biosimilars in oncology in France

Biosimilars/Research | Posted 02/09/2016

Biosimilar drugs are biological drugs clinically similar to their reference products. They correspond to a generic drug approach applied to biological agents. The goal of biosimilars is to open the market and to provide significantly less costly biological agents. The approval of biosimilars is abbreviated when compared to that of the reference biologicals, but includes clinical trials (distinguishing them from generics). In oncology, the currently available biosimilars filgrastim and epoetin alfa are used in supportive care. Author Dominique Leveque from the Hôpital Hautepierre, Strasbourg, France discusses the situation regarding the use of biosimilars in France [1].

FDA accepts application for Merck’s follow-on insulin glargine

Biosimilars/News | Posted 02/09/2016

US pharma giant Merck announced on 5 August 2016 that its regulatory submission for its proposed follow-on insulin glargine product (MK-1293) had been accepted by the US Food and Drug Administration (FDA).