Biosimilars/General

Increasing access to biosimilars and generics in Europe

On 2 March 2017, the European Parliament voted on a resolution to strike a better balance between European Union (EU) countries’ public health interests and those of the pharmaceutical industry.

Amgen at the centre of biosimilars disputes

The disputes involve a biosimilar of Amgen’s biosimilar of Roche’s Avastin (bevacizumab) and Amgen’s blockbuster Neulasta (pegfilgrastim) being made by Coherus Biosciences.

FDA biologicals naming guidance could cost providers billions

Healthcare organizations have expressed their ‘grave concerns’ over the ‘enormous financial consequences’ of the US Food and Drug Administration’s (FDA) guidance on naming of biologicals.

Pharma associations issue position paper on biosimilar switching

The European Federation of Pharmaceutical Industries and Associations (EFPIA), European Biopharmaceutical Enterprises (EBE) and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) have issued joint guidance for prescribers on switching between originator biologicals and biosimilars.

Biosimilars in 2016: the highlights

Previous years have been momentous for the biosimilars industry and 2016 is no exception [1]. Important milestones achieved during 2016 were the biosimilar approvals of Inflectra (infliximab-dyyb), Erelzi (etanercept-szzs) and Amjevita (adalimumab-atto) by the US Food and Drug Administration (FDA).

EMA to launch pilot for tailored advice on biosimilars development

The European Medicines Agency (EMA) announced on 16 December 2016 that it is planning to provide sponsors with tailored scientific advice on the development of biosimilars as part of a pilot programme that will be launched in February 2017.

EC publishes improved biosimilars information for patients

On 23 January 2017, the European Commission (EC) published a unique question and answer (Q&A) document for patients containing reliable information on biosimilar medicines.

European IBD specialists support switching to biosimilars

The European Crohn’s and Colitis Organization (ECCO) has published results of a consensus meeting held on 15 October 2016 in Vienna, Austria in which they support switching from reference infliximab to biosimilar infliximab [1].

European oncologists back biosimilars with position paper

On 16 January 2017, the European Society for Medical Oncology (ESMO) published a position paper on biosimilars saying that ‘biosimilars create opportunities for sustainable cancer care’ [1].

What happened in biosimilars during 2015

The past year has once again been a busy one for the biosimilars industry [1]. The most important milestone achieved during 2015 was the landmark decision made by the US Food and Drug Administration (FDA) on 6 March 2015 to approve Sandoz’s filgrastim biosimilar, Zarxio (filgrastim-sndz), for all five indications of the originator product (Neupogen). FDA is also reviewing applications for epoetin alfa, infliximab, etanercept filgrastim and pegfilgrastim biosimilars.

US$67 billion worth of biosimilar patents expiring before 2020

Last updated: 20 January 2014

Twelve biological products with global sales of more than US$67 billion will be exposed to biosimilar competition by 2020, with Enbrel (etanercept) whose US patent has been extended until 2028, scoring global sales of US$7.3 billion by December 2011; coming in second after Humira (adalimumab) with global sales of US$7.9 billion [1].

Position statement on approval of biosimilars in Latin America

The Fifth Latin American Forum on Biosimilars (FLAB) was held in Brasilia, Brazil in 2015 with the theme of ‘Interchangeability and Automatic Substitution’.  Discussions centred on the approval of CT-P13, an infliximab biosimilar; and RTXM83, a proposed rituximab biosimilar, in both Brazil and Argentina. Following these discussions, Babini et al. [1] published a FLAB position statement on the approval of these monoclonal antibody biosimilars in the context of current regulations in these two Latin American countries.

Biosimilars applications under review by EMA – December 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.

Portuguese dermatologists’ position on the use of biosimilars in psoriasis

Biologicals have revolutionized the treatment of psoriasis and psoriatic arthritis. However, they impose a heavy burden on the healthcare system due to their high costs. In 2013, 27% of pharmaceutical sales were for biologicals. In 2015, two of the top five best-selling therapies were tumour necrosis factor-alpha (TNF-α) inhibitors, adalimumab and etanercept. Biosimilars, which may cost 25−30% less than the originator biological, thus represent a significant opportunity for savings to be made by both patients and healthcare systems.

Biosimilars of natalizumab

Natalizumab is a humanized monoclonal antibody against the cell adhesion molecule α4-integrin. Natalizumab is believed to work by reducing the ability of inflammatory immune cells to attach to and pass through the cell layers lining the intestines and blood–brain barrier. Natalizumab is indicated for the treatment of multiple sclerosis (US and Europe) and Crohn’s disease (US).

WHO proposes provisional implementation of biological qualifier

The World Health Organization (WHO) first introduced the concept of a biological qualifier (BQ) for naming biologicals back in 2014. This was followed by a draft proposal on naming biologicals, including biosimilars [1]. This has now been followed by the proposal to proceed with a provisional implementation of the BQ scheme accompanied by a prospective impact study.

Merck launches biosimilars educational resource for patients

US pharma giant Merck (known as MSD outside the US and Canada) has launched an online resource intended to be used as an educational platform for patients, caregivers and the healthcare community.

Court rules in favour of Apotex in biosimilars dispute

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.

Biosimilar User Fee Act reauthorization

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.

Biosimilars applications under review by EMA – August 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.

Biosimilars of basiliximab

Basiliximab is a chimeric mouse-human monoclonal antibody to the α chain (CD25) of the IL-2 receptor of T cells. It is an immunosuppresant agent used to prevent immediate transplant rejection in people who are receiving kidney transplants, in combination with other agents.

WHO naming of biosimilars

The World Health Organization (WHO) has proposed a system of naming for biosimilars, which has been commended by some groups [1], but criticized by others.

Sandoz plans to launch five more biosimilars by 2020

Sandoz, the generics division of Novartis, has announced plans for five major global biosimilar launches by 2020.

Roche sues India’s drug regulator over Avastin ‘similar biologics’

Switzerland-based drug giant Roche has sued the Drug Controller General of India (DCGI) in the Delhi High Court over ‘similar biologic’ versions of its cancer blockbuster Avastin (bevacizumab).

Japan proving to be a favourable market for biosimilars

Uptake of biosimilars in Japan is on a par with generics use for some products, making Japan a lucrative market for biosimilars makers.

Benepali wins Danish tender for etanercept

Denmark’s drug procurement agency Amgros has chosen the etanercept biosimilar Benepali, made by Samsung Bioepis, as the priority drug for treating rheumatoid arthritis rather than the originator biological (Amgen’s Enbrel).

Biosimilars applications under review by EMA – April 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.

Biosimilar etanercept offered at 47% discount in Norway

Samsung Bioepis confirmed on 1 February 2016 that it had won a contract in Norway to supply its newly approved biosimilar etanercept, Benepali, to the country.

Biosimilars applications under review by EMA – December 2015

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.

Biosimilars applications under review by EMA – August 2015

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.

Biosimilars applications under review by EMA – April 2015

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.

Biosimilars on the horizon

Europe approved its first monoclonal antibody biosimilar, Inflectra/Remsima (infliximab), in September 2013 [1]. But how does the pipeline look for biosimilars and what will be the next biosimilar to be approved?

Biosimilars group launched in UK to improve biosimilars uptake

On 18 April 2016, the British Generic Manufacturers Association (BGMA) announced the launch of its expert sector group on biosimilars, the British Biosimilars Association (BBA).

US rheumatologists in favour of distinct names for biosimilars

Following the approval of the infliximab biosimilar Inflectra (infliximab-dyyb) the American College of Rheumatology (ACR) has issued a statement supporting the use of distinct names for biosimilars.

IPRF template for summary information for biosimilar reviews

The Biosimilars Working Group (BWG) of the International Pharmaceutical Regulators Forum (IPRF) has released a template for Public Assessment Summary Information for Biosimilar (PASIB).

IGBA opposes WHO biological qualifier

The World Health Organization (WHO) is considering a proposal to assign Biological Qualifiers (BQs), which are random alphabetic codes, to help standardize the naming of biologicals, including biosimilars [1]. However, not everyone agrees with their proposal.

US doctors poised to prescribe biosimilars

A survey of specialists in the US has found that nearly half of them expect to prescribe biosimilars to treatment-naïve patients.

Amgen sues Sandoz over etanercept biosimilar

Following the submission of application for approval of its etanercept biosimilar in the US, Sandoz is coming under fire from originator company Amgen.

Sandoz acquires EEA rights to infliximab biosimilar from Pfizer

Sandoz, the generics division of Novartis, announced on 12 February 2016 that it had acquired the rights for the development and commercialization of Pfizer’s biosimilar infliximab (PF-06438179) in the European Economic Area (EEA), which includes the 28 countries of the European Union (EU), plus Iceland, Liechtenstein and Norway.

FDA releases ‘Overview of Biosimilar Products’

As part of its ongoing mission to educate industry, the public and healthcare professionals about biosimilars, the US Food and Drug Administration (FDA) has released an online educational course for healthcare professionals.