Biosimilars

Adalimumab copy biologicals accepted for review in China

Biosimilars/News | Posted 28/09/2018

China Food and Drug Administration (CFDA) has accepted applications for approval of adalimumab copy biologicals from Hisun Pharma (Hisun) and Bio‑Thera Solutions (Bio‑Thera).

Recommendations for biosimilars in rheumatology in the Middle East

Biosimilars/Research | Posted 28/09/2018

The increasing availability of biosimilars in Middle Eastern regions may provide an opportunity to increase the number of rheumatology patients who have access to traditionally more expensive biologicals. However, as well as a lack of real-world data on the use of biosimilars in practice, the availability of ‘intended copies*’ in the region may undermine physician confidence in prescribing legitimate biosimilars. There is a need for regional recommendations for healthcare professionals to ensure that biosimilars can be used safely.

Samsung Bioepis sued over trastuzumab biosimilar but win for Celltrion’s biosimilar Inflectra

Biosimilars/General | Posted 28/09/2018

Roche’s Genentech has sued Samsung Bioepis regarding its trastuzumab biosimilar, but Celltrion has won its patent battle against Johnson & Johnson (J&J).

Improving understanding of biotherapeutics and biosimilars

Biosimilars/General | Posted 21/09/2018

Additional information on biosimilars and biotherapeutics have been published in Europe.

Selection of quality attributes and test methods in biosimilarity assessment

Biosimilars/Research | Posted 21/09/2018

Biosimilar development starts with a detailed characterization of the quality profile of the chosen reference product, to establish targets for cell line and process development, according to author Vandekerckhove and colleagues [1]. This characterization requires a careful determination of the range of variability for all relevant product quality attributes of the reference product, as well as an understanding of their relative importance, to ensure appropriate focus on the most important attributes. Following process development, similarity of the biosimilar candidate with the reference product must be demonstrated in comprehensive analytical studies. This first step in the demonstration of biosimilarity provides the most sensitive measurement of differences; and is instrumental in deciding the direction of further product development. Meticulous design of the analytical similarity programme is therefore critical to the success of biosimilar development.

Adalimumab and trastuzumab biosimilars gain EC approval

Biosimilars/News | Posted 21/09/2018

A trastuzumab biosimilar from Pfizer and three adalimumab biosimilars from Sandoz have been approved by the European Commission (EC).

Increase in use of biosimilar rituximab for NHL treatment

Biosimilars/Research | Posted 21/09/2018

Researchers from the UK and US reported on how the treatment approach for non-Hodgkin lymphoma (NHL) patients has changed since the first biosimilars of rituximab were approved in the European Union five (EU5: France, Germany, Italy, Spain, UK) [1].

Japan approves first darbepoetin alfa biosimilar

Biosimilars/News | Posted 14/09/2018

Japan-based Kyowa Hakko Kirin announced on 16 August 2018 that it had gained Japanese approval for its darbepoetin alfa biosimilar.

Extension of indications and manufacturing approval for biologicals in the US

Biosimilars/General | Posted 14/09/2018

Filgrastim biosimilar Granix (tbo-filgrastim) has been approved for extended indications and Samsung BioLogics has received approval to manufacture a monoclonal antibody drug product.

Comparison of biosimilar and originator bevacizumab in NSCLC

Biosimilars/Research | Posted 14/09/2018

A study carried out by international researchers reported results from a comparative clinical study of PF‑06439535, a candidate bevacizumab biosimilar compared to originator bevacizumab, in patients with advanced non-squamous non-small cell lung cancer (NSCLC) [1].

FDA guidance sought on false and misleading information on biosimilars

Biosimilars/General | Posted 07/09/2018

Pharma giant Pfizer has asked the US Food and Drug Administration (FDA) to issue guidance ‘clarifying appropriate sponsor communications about the nature and properties of biosimilars’.

Trastuzumab and Bevacizumab products approved in Australia and Argentina

Biosimilars/News | Posted 07/09/2018

Australia has approved a trastuzumab biosimilar and Argentina has approved a bevacizumab medicamento biológico similar.

Pooled analysis results of adalimumab, etanercept and infliximab biosimilars

Biosimilars/Research | Posted 07/09/2018

South Korean electronics giant Samsung and biotechnology company Biogen Idec (Biogen) joint venture Samsung Bioepis, along with Biogen, announced on 13 June 2018 results of a pooled analysis combining data from three phase III trials that compared the efficacy and safety of anti-tumour necrosis factor (anti-TNF) biosimilars to their reference biologicals.

Comparison of trial and real-world data for biosimilar filgrastim

Biosimilars/Research | Posted 07/09/2018

A study carried out by researchers from Germany compared results from a randomized controlled trial (RCT) of Sandoz’s biosimilar filgrastim and post-approval data on the safety of the biosimilar [1].

EMA approves adalimumab and pegfilgrastim biosimilars

Biosimilars/News | Posted 31/08/2018

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 27 July 2018 that it had recommended granting marketing authorization for the adalimumab biosimilar Hulio and also for the pegfilgrastim biosimilars Pelgraz and Udenyca.

Alternative mAb purification strategies: a tool to increase global access to biotherapeutics?

Biosimilars/Research | Posted 31/08/2018

The monoclonal antibodies’ (mAbs) market is dominant among therapeutic biologicals. Between 2013 and 2017, it has witnessed the approval of 11 biosimilars and 33 new molecules by the regulatory authorities in the EU and the US [1]. A foreseen increase in demand arising from both the western world and several developing countries requires a productivity increase at the same time that the biopharmaceutical industry is being pressured to reduce the costs of life-saving drugs.