Biosimilars

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].

More discussion over WHO biological qualifier

Biosimilars/General | Posted 21/11/2014

The World Health Organization recently held its 59th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances. At the meeting the issue of naming of biologicals including biosimilars was once again discussed.

Amgen launches biosimilars info app

Biosimilars/News | Posted 21/11/2014

Biologicals major Amgen has launched an app which aims to provide a source of information about biosimilars.

Biosimilars: when indications can be extrapolated

Biosimilars/Research | Posted 14/11/2014

Extrapolation* is already a well-established and accepted scientific and regulatory principle, according to members of the European Medicines Agency's (EMA) Biosimilar Medicinal Products Working Party (BMWP) [1].

Amgen sues Sandoz over filgrastim biosimilar

Biosimilars/News | Posted 14/11/2014

Biologicals major Amgen is suing Sandoz to stop the biosimilars maker from marketing a biosimilar of its top-selling product Neupogen (filgrastim) in the US. Amgen claims in its lawsuit that Sandoz did not follow the rules for biosimilar development.

Biosimilars: similar but not identical

Biosimilars/Research | Posted 07/11/2014

One reason for distrust among physicians over using biosimilars in extrapolated* indications could be the fact that it is frequently cited that biosimilars are ‘similar but not identical’ compared to small molecule generics, which are often referred to as ‘identical’.

Predicting the response of diabetes patients to biosimilar insulin

Biosimilars/Research | Posted 07/11/2014

For patients with type 1 diabetes, the quality of the insulin they take is a matter of life and death. The situation is similar for patients with type 2 diabetes. The question is what will these patients think about switching from their current brand-name insulins to new biosimilar versions? The question is important right now with the imminent arrival of biosimilar insulins on the market.

Study into switching from Aranesp to biosimilar epoetin alfa

Biosimilars/News | Posted 07/11/2014

Biologicals major Amgen has started recruiting patients for a clinical trial to study the effect of switching patients from the originator biological Aranesp (darbepoetin alfa) to biosimilar epoetin alfa, in other words, from a long-acting to a short-acting epoetin.

Coherus sells shares to raise funds for biosimilars programme

Biosimilars/News | Posted 07/11/2014

US-based biosimilars developer Coherus BioSciences (Coherus) is looking for further funding for its biosimilar programme. The company is preparing to sell shares in the company in order to raise funds to get three of the biosimilars in its pipeline through clinical trials.

Improved labelling sought for biosimilar acceptance

Biosimilars/Research | Posted 31/10/2014

The terms of approval for every biosimilar and its reference product must be made clearer, argue the European Biopharmaceutical Enterprises (EBE) [1]. The development of biosimilar regulatory pathways worldwide has been led by the European Medicines Agency (EMA) [2], but EMA’s information-driven stepwise approach is only reflected in a single section of the product labelling for healthcare professionals and patients, which so far has followed a generic approach in Europe.