Biosimilars

Switching to biosimilars in rheumatology

Biosimilars/Research | Posted 26/01/2018

Researchers from Argentina, Brazil, Germany, the UK and the US investigated switching from originator biologicals to biosimilars [1].

EMA accepts application for pegfilgrastim biosimilar from USV

Biosimilars/News | Posted 26/01/2018

India-based biologicals specialist USV Biologics (USV) announced on 7 December 2017 that the application for approval for its proposed pegfilgrastim biosimilar has been accepted by the European Medicines Agency (EMA).

Biosimilars applications under review by EMA – January 2018

Biosimilars/General | Posted 19/01/2018

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.

Additional clinical data for Cinfa’s pegfilgrastim biosimilar

Biosimilars/Research | Posted 19/01/2018

Spanish biosimilars developer Cinfa Biotech (Cinfa) announced on 2 November 2017 additional clinical data for its candidate pegfilgrastim biosimilar (B12019).

FDA approves follow-on insulin lispro Admelog

Biosimilars/News | Posted 19/01/2018

Pharma giant Sanofi announced on 11 December 2017 that the US Food and Drug Administration (FDA) had approved its follow-on version of Eli Lilly’s Humalog (insulin lispro).

Switching failures with biosimilar etanercept

Biosimilars/Research | Posted 12/01/2018

A study carried out by researchers from Denmark has found that switching from originator to biosimilar etanercept does not work for all patients [1].

FDA approves biosimilar infliximab Ixifi

Biosimilars/News | Posted 12/01/2018

Pfizer announced on 13 December 2017 that the US Food and Drug Administration (FDA) had approved its biosimilar version of Johnson & Johnson and Merck’s Regicide (infliximab).

Bevacizumab similar biologic launched in India

Biosimilars/News | Posted 12/01/2018

India-based biologicals specialist Biocon announced on 23 November 2017 the launch of its product Krabeva, a ‘similar biologic’ of bevacizumab, in India.

FDA approves trastuzumab biosimilar Ogivri

Biosimilars/News | Posted 05/01/2018

On 1 December 2017, the US Food and Drug Administration (FDA) approved its first trastuzumab biosimilar.

Reimbursement for oncology biosimilars in the US

Biosimilars/Research | Posted 05/01/2018

How reimbursement issues for biosimilars might affect US oncologists was a subject discussed by Dr Rena Conti, Associate Professor of Health Policy and Economics in the Department of Paediatrics at the University of Chicago, USA [1].

Roche sues Pfizer over Herceptin biosimilar

Biosimilars/General | Posted 05/01/2018

Switzerland-based drug giant Roche has sued pharma giant Pfizer for patent infringement on its blockbuster breast cancer drug Herceptin (trastuzumab) in an attempt to block competition from Pfizer’s trastuzumab biosimilar.

Impact of follow-on biological products in the Brazilian health system

Biosimilars/Research | Posted 05/01/2018

Cancer is an epidemic disease in the 21st century. However, despite consistent increases on its incidence worldwide, mortality rates have fallen, especially in developed countries [1, 2]. The victories mankind has achieved in the war against cancer result from advances in different fields, such as early diagnosis and better surgical, radiotherapeutic and systemic treatments.

EC publishes biosimilar Q&A document for patients in 23 languages

Biosimilars/General | Posted 08/12/2017

On 29 November 2017, the European Commission (EC) published a patient-focused Questions and Answers (Q&A) document on biosimilar medicines aimed at patients and the general public.

Hospital specialists and pharmacists surveyed about biosimilars

Biosimilars/Research | Posted 08/12/2017

Biological medicines are essential for many acute and chronic conditions, but their consumption differs widely among European countries [1, 2]. In contrast with the procedures for their approval[3], position papers from scientific societies suggest that biosimilars need to be tested in well-designed, randomized, controlled clinical trials, especially for extrapolation of indications [4, 5]. Nevertheless, switches with originators are becoming common and no serious adverse effects have been reported to date [6-8].

EMA accepts applications for pegfilgrastim and trastuzumab biosimilars from Biocon/Mylan

Biosimilars/News | Posted 08/12/2017

India-based biologicals specialist Biocon and US-based partner Mylan announced on 1 December 2017 that the applications for approval for their proposed pegfilgrastim (MYL‑1401H) and trastuzumab (MYL‑1401O) biosimilars have been accepted by the European Medicines Agency (EMA).

Positive phase III switching results for Celltrion’s infliximab biosimilar

Biosimilars/Research | Posted 08/12/2017

Results of a phase III extension study have shown that Celltrion Healthcare’s (Celltrion) infliximab biosimilar (CT-P13) is shown to be comparable in efficacy and safety to Johnson & Johnson/Merck’s Remicade in switched inflammatory bowel disease patients, according to the South Korean biotechnology company.

EC approval for trastuzumab biosimilar Ontruzant

Biosimilars/News | Posted 01/12/2017

South Korean electronics giant Samsung and biotechnology company Biogen Idec’s joint venture Samsung Bioepis announced on 20 November 2017 that it had received European Commission (EC) approval for its biosimilar trastuzumab product Ontruzant (SB3).

Switching from reference infliximab to CT P13 in IBD patients

Biosimilars/Research | Posted 01/12/2017

Argüelles-Arias and colleagues from the Hospital Universitario Virgen Macarena and the University of Seville in Spain carried out an observational study assessing the efficacy and safety of switching from Remicade to CT P13 in patients with inflammatory bowel disease (IBD) for up to 12 months [1].

South Africa approves first non-originator biological

Biosimilars/News | Posted 01/12/2017

South Africa’s Medicines Control Council (MCC) has approved the country’s first non-originator biological, filgrastim, from Teva Pharmaceutical Industries (Teva).

Biosimilars in oncology in Europe

Biosimilars/Research | Posted 01/12/2017

In the European Union (EU), a legal framework for approving biosimilars was established back in 2003. This framework allows for biosimilars to be approved using an abbreviated pathway centrally via the European Medicines Agency (EMA) [1].