Biosimilars

Filgrastim biosimilar has similar safety and efficacy to Neupogen

Biosimilars/Research | Posted 23/01/2015

A filgrastim biosimilar (EP2006) from Sandoz, the generics division of Swiss pharma giant Novartis, has shown similar safety and efficacy compared to Amgen’s Neupogen (filgrastim) in a pivotal phase III clinical study.

Mabion starts phase III trial for rituximab biosimilar

Biosimilars/News | Posted 23/01/2015

Polish biologicals company Mabion announced on 25 November 2014 that it had received the consent of the appropriate regulatory authorities in Croatia, Bosnia and Herzegovina, Serbia and Poland to start a phase III clinical trial for its rituximab biosimilar (MabionCD20) in patients with diffuse large B-cell lymphoma.

Hospira submits application to FDA for epoetin alfa biosimilar

Biosimilars/News | Posted 16/01/2015

US-based injectables specialist Hospira announced on 12 January 2015 that it had submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for its epoetin alfa biosimilar Retacrit.

Biocomparable has comparable safety and efficacy to originator erythropoietin in haemodialysis patients

Biosimilars/Research | Posted 16/01/2015

A study of the treatment of patients with chronic kidney disease undergoing haemodialysis with ‘biocomparable’ and originator erythropoietin in Mexico has shown comparable efficacy and safety in terms of changes in haemoglobin levels [1].

Apotex pegfilgrastim biosimilar under FDA review

Biosimilars/News | Posted 16/01/2015

Canada-based Apotex announced on 17 December 2014 that the US Food and Drug Administration (FDA) had accepted for filing the company’s application for a biosimilar version of Amgen’s Neulasta (pegfilgrastim).

Efficacy, Extrapolation, Interchangeability V16E25LB

Extrapolation of indications in biosimilars: infliximab

Biosimilars/Research | Posted 09/01/2015

Physicians may not be well informed about the scientific concept underlying the principle of extrapolating* indications for biosimilars. This in turn may lead them to distrust biosimilars, leading to a lower than expected uptake in Europe, especially in extrapolated indications. Members of the European Medicines Agency’s (EMA) Working Party on Similar Biological (Biosimilar) Medicinal Products (BMWP) address these concerns using extrapolation of indications in biosimilar infliximab as an example [1].

FDA advisers recommend approval of filgrastim biosimilar

Biosimilars/News | Posted 09/01/2015

US Food and Drug Administration (FDA) advisers have voted unanimously to recommended approval for Sandoz’s biosimilar version of Amgen’s Neupogen (filgrastim), a development that could make complex biological therapies more readily accessible in the US.

First infliximab ‘similar biologic’ launched in India

Biosimilars/News | Posted 09/01/2015

India-based Ranbaxy Laboratories (Ranbaxy) announced on 1 December 2014 that it had launched its infliximab ‘similar biologic’, BOW015 in India. This is the first infliximab similar biologic to be launched in India.

Phase I study shows darbepoetin alfa biosimilar to be well tolerated

Biosimilars/Research | Posted 09/01/2015

Chong Kun Dang Pharmaceutical (CKD Pharma) announced on 18 November 2014 the successful completion of its phase I pharmacokinetics study for its biosimilar darbepoetin alfa product.

Extrapolation of indications in biosimilars: epoetin

Biosimilars/Research | Posted 12/12/2014

Despite a stringent approval process, acceptance of biosimilars in the medical community continues to be low, and especially in extrapolated* indications. Members of the European Medicines Agency's (EMA) Biosimilar Medicinal Products Working Party (BMWP) address these concerns using extrapolation of indications in biosimilar epoetin as an example [1].

Non-biological complex drug concept: experiences with iron sucrose and low molecular weight heparin

Biosimilars/Research | Posted 12/12/2014

When the patent of a classical small molecule drug expires, generics may be marketed if their therapeutic equivalence to the originator drug has been established. The therapeutic equivalence of a drug includes both pharmaceutical equivalence and bioequivalence and do not require formal clinical efficacy and safety studies. The demonstration of therapeutic equivalence then allows for the interchangeability of the generic and originator drug. This approach has so far only been applied to products that can be fully characterized. For more complex molecules, which are difficult to characterize, such as proteins, the demonstration of bioequivalence requires an alternative approach.

Momenta gains approval to start biosimilar adalimumab trial in Europe

Biosimilars/News | Posted 12/12/2014

US-based biotechnology firm Momenta Pharmaceuticals (Momenta) announced on 1 December 2014 the acceptance by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) of a clinical trial application to initiate a clinical trial for its adalimumab biosimilar, M923.

US biosimilar uptake in the light of Obamacare

Biosimilars/Research | Posted 05/12/2014

A literature review by researchers at Tufts University in the US concludes that market uptake of biosimilars in the US will depend on regulatory policies, including the smoothing out of issues concerning the country’s Food and Drug Administration (FDA) regulatory pathway [1, 2]. The review comes in the light of a new approval pathway for biosimilars established as part of the US Government’s Affordable Care Act, more widely known as Obamacare.

Biosimilar infliximab launched in Japan

Biosimilars/News | Posted 05/12/2014

Japanese pharma firm Nippon Kayaku announced on 28 November 2014 the launch of its infliximab biosimilar, Infliximab BS, in Japan.

Use of biosimilars in rheumatology

Biosimilars/Research | Posted 05/12/2014

In order to issue a position statement on the use of biosimilars in rheumatic diseases, the Sociedade Portuguesa de Reumatologia (Portuguese Society of Rheumatology) carried out two systematic literature reviews: one on clinical trials and one on international position papers for biosimilars [1].

Stada to in-license adalimumab biosimilar

Biosimilars/News | Posted 05/12/2014

German generics giant Stada Arzneimittel (Stada) announced on 18 November 2014 that it was in negotiations to in-licensing an adalimumab biosimilar.

Comparison of biosimilar filgrastim versus other G-CSF formulations after autologous stem cell transplantation

Biosimilars/Research | Posted 28/11/2014

Introduction
Only limited data have been so far published about the use of biosimilar filgrastim in haematologic recovery after autologous stem cell transplantation (ASCT). Despite the limitation due to retrospective analysis performed on a limited number of patients, all these studies suggest a substantially similar efficacy of biosimilar products, when compared to originators in the febrile neutropenia prophylaxis of lymphoma and myeloma patients post-ASCT. The aim of this study was to compare the biosimilar filgrastim Zarzio with the other available formulations of granulocyte colony-stimulating factor (G-CSF) in terms of efficacy and safety [1].

EuropaBio calls for distinguishable names for biosimilars despite potential of big savings

Biosimilars/General | Posted 28/11/2014

On 6 November 2014, the European Association for Bioindustries (EuropaBio) published a new guide and a new position paper on biosimilars in Europe. EuropaBio expects these two documents to contribute to the policy debate on key issues regarding biosimilars among European and national regulators, policymakers, physicians, other healthcare providers, and patients.

Amgen expands biosimilars programme

Biosimilars/News | Posted 28/11/2014

Biologicals major Amgen is expanding its biosimilars portfolio to include nine different molecules.

Extrapolation of indications in biosimilars: filgrastim

Biosimilars/Research | Posted 21/11/2014

Extrapolation* of indications for biosimilars is a contentious issue and has been met with concern by physicians. Members of the European Medicines Agency's (EMA) Biosimilar Medicinal Products Working Party (BMWP) address these concerns using extrapolation of indications in biosimilar filgrastim as an example [1].