Biosimilars

US doctors poised to prescribe biosimilars

Biosimilars/General | Posted 18/03/2016

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

Benefits and concerns related to biosimilars

Biosimilars/Research | Posted 18/03/2016

As patents of the first introduced biological therapeutics in oncology have begun to expire, competing pharmaceutical companies are allowed to produce and market the same protein as the originator agent. This follows the pattern of the development of generics. However, biosimilars are fundamentally different from generics. Particularly in the field of oncology, the introduction of monoclonal antibodies has resulted in spectacular therapeutic advances by increasing the cure rate of early cancers and prolonging survival. Similar advances have occurred in rheumatology, haematology, neurology and other fields. Most therapeutic biologicals are monoclonal antibodies with molecular weights of around 140,000 Daltons [1]. Other peptides include hormones, growth factors and vaccines [2]. Most of those products are expensive and their broad application drains the financial resources of healthcare systems. Therefore, the development of biosimilars is expected to be mutually beneficial for both the pharmaceutical industry and society: pharmaceutical companies may enter a lucrative business, whereas payers reasonably expect lower prices for these costly but essential drugs.

Merck Group starts phase III trial for adalimumab biosimilar

Biosimilars/News | Posted 18/03/2016

Germany’s Merck KGaA (Merck Group) announced on 2 March 2016 that it had started a phase III clinical trial for its adalimumab biosimilar (MSB11022) in patients with chronic plaque psoriasis.

Extrapolation of indications for mAbs

Biosimilars/Research | Posted 11/03/2016

Monoclonal antibody (mAb) biosimilars have recently entered the market, raising questions in the healthcare community. One of the questions discussed by Professor Pierre Michetti, a gastroenterologist at the Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland, was that of extrapolation of indications for mAbs [1].

Amgen sues Sandoz over etanercept biosimilar

Biosimilars/General | Posted 11/03/2016

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

Epirus starts phase III trial for infliximab biosimilar

Biosimilars/News | Posted 11/03/2016

US-based biologicals company Epirus Biopharmaceuticals (Epirus) announced on 9 February 2016 that it had started a phase III trial for its infliximab biosimilar (BOW015).

Beyond biosimilarity

Biosimilars/Research | Posted 04/03/2016

The advent of monoclonal antibody (mAb) biosimilars has raised a series of questions in the healthcare community. Just a few of these questions were discussed by Professor Pierre Michetti, a gastroenterologist at the Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland [1]. 

Sandoz acquires EEA rights to infliximab biosimilar from Pfizer

Biosimilars/General | Posted 04/03/2016

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’

Biosimilars/General | Posted 26/02/2016

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.

Trastuzumab non-originator biological approved in Russia

Biosimilars/News | Posted 26/02/2016

Russian biotechnology company Biocad announced on 20 January 2016 that the Russian Ministry of Health had approved the company’s trastuzumab non-originator biological, BCD-022. The drug is a non-originator biological of Roche’s breast cancer blockbuster Herceptin (trastuzumab).

Efficacy and safety of biosimilar infliximab compared to other biologicals in rheumatoid arthritis

Biosimilars/Research | Posted 26/02/2016

In the paper by Baji et al. [1], the authors carried out a meta-analysis to compare the efficacy and safety of biosimilar infliximab and other available biologicals for the treatment of rheumatoid arthritis (RA), namely abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab and tocilizumab. The analysis compared the recommended doses of biological disease-modifying anti-rheumatic drugs (DMARDs) indicated in RA.

Safety concerns limit similar biologics uptake in India

Biosimilars/Research | Posted 26/02/2016

How do concerns about the safety of domestic biologicals limit the uptake of ‘similar biologics’ in India? This is a question that author Malipatil tried to address in his review of similar biologics in India [1].

Differences between biosimilars and reference products

Biosimilars/Research | Posted 19/02/2016

A review of glycosylated biosimilars approved in the European Union (EU) and Japan has highlighted structural variances between biosimilars and their reference products [1].

FDA advisers recommend approval of Celltrion’s infliximab biosimilar

Biosimilars/News | Posted 19/02/2016

US Food and Drug Administration’s (FDA) advisers have voted to recommend the approval of Celltrion’s biosimilar version of Johnson & Johnson and Merck’s arthritis treatment Remicade (infliximab).

EMA accepts application for pegfilgrastim biosimilar

Biosimilars/News | Posted 19/02/2016

Sandoz, the generics division of Novartis, announced on 11 February 2016 that its regulatory submission for its proposed pegfilgrastim biosimilar (LA-EP2006) had been accepted by the European Medicines Agency (EMA).

Celltrion to use cloud-based technology for its biosimilars trials

Biosimilars/General | Posted 19/02/2016

On 20 January 2016, Korea-based biopharmaceutical company Celltrion announced that it had adopted Medidata’s Clinical Cloud to provide scalable technology for its biosimilars development programmes. The technologies include electronic data capture and management (Medidata Rave), medical coding (Medidata Coder) and randomization and trial supply management (Medidata Balance).

Pharmacovigilance for biologicals in The Netherlands

Biosimilars/Research | Posted 12/02/2016

Escher is an independent regulatory research platform run by Netherlands-based research enabler TI Pharma. The group recently published a paper in the journal Drug Safety on the traceability of biologicals in clinical practice and adverse drug reaction (ADR) reporting [1]. This paper concludes that in The Netherlands brand names are not routinely recorded in clinical practice and batch numbers are poorly recorded. The findings suggest that the limited traceability of brand names and batch numbers in ADR reports for biologicals may be primarily caused by the shortcomings in the recording and tracing of information in clinical practice.

Launch of partnership for biosimilars education and access

Biosimilars/General | Posted 12/02/2016

The Biosimilars Forum announced on 1 February 2016 the launch of a new biosimilars education initiative. The ‘Partnership for Biosimilars Education and Access’ will focus on raising awareness and encouraging access to biosimilars in the US.

Kyowa to market Sandoz’s rituximab biosimilar in Japan

Biosimilars/News | Posted 12/02/2016

Biotech firm Kyowa Hakko Kirin (Kyowa) announced on 25 January 2016 that it had made a deal with Sandoz, the generics division of Novartis, for exclusive marketing rights to Sandoz’s biosimilar rituximab in Japan.

Adalimumab biosimilar meets primary endpoint in pharmacokinetic study

Biosimilars/Research | Posted 12/02/2016

On 21 December 2015, Baxalta, a spinoff company from Baxter International, and US-based biotechnology firm Momenta Pharmaceuticals (Momenta) announced positive results from a pharmacokinetic study with their candidate adalimumab biosimilar M923.