Biosimilars

Incomplete processing in recombinant streptokinase

Biosimilars/Research | Posted 29/05/2015

A study investigating the impact of incomplete processing on streptokinase activity has found that ‘similar biologics’ or different batches of the biological may have different potencies, depending on the degree of amino-terminal methionine processing and on the pharmacopoeial assay method used, affecting the dosage patients receive [1].

Latin American deal for infliximab biosimilar

Biosimilars/News | Posted 29/05/2015

US-based Epirus Biopharmaceuticals (Epirus) announced on 14 May 2015 that it had made a deal with biosimilars specialist mAbxience, a subsidiary of Spanish healthcare firm the Chemo Group, for Latin America with respect to the infliximab biosimilar made by Epirus.

GPhA launches Biosimilars Council

Biosimilars/General | Posted 29/05/2015

As part of ongoing efforts to educate and expand access to biosimilars, industry group, the US Generic Pharmaceutical Association (GPhA), has launched its Biosimilars Council, a division of GPhA.

Baxter and Coherus amend biosimilar etanercept collaboration

Biosimilars/News | Posted 29/05/2015

US-based biosimilars developer Coherus BioSciences (Coherus) and Baxter International (Baxter) announced on 15 April 2015 that they had amended some of the financial terms of their collaboration agreement for CHS-0214, an etanercept biosimilar candidate.

Clinical trials for etanercept biosimilars

Biosimilars/Research | Posted 22/05/2015

Researchers from the Charité – Universitätsmedizin Berlin, Germany, carried out a systematic review into clinical trials for etanercept biosimilars as part of their investigation into biosimilars for the treatment of psoriasis [1].

Australian approval for biosimilar insulin

Biosimilars/News | Posted 22/05/2015

Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) has given a positive recommendation for the listing of Eli Lilly’s biosimilar insulin glargine, Basaglar in the country’s Pharmaceutical Benefits Scheme (PBS). Basaglar is the first biosimilar insulin to be approved in Australia, providing an alternative, affordable treatment option for patients suffering from diabetes.

Variation in recombinant streptokinase

Biosimilars/Research | Posted 22/05/2015

A study of blood clot dissolving drug streptokinase has highlighted the mantra of ‘the process is the product’ in the case of biologicals [1].

Clinical trials for adalimumab biosimilars

Biosimilars/Research | Posted 15/05/2015

As part of their investigation into biosimilars for the treatment of psoriasis, researchers from the Charité – Universitätsmedizin Berlin, Germany, carried out a systematic review into clinical trials for adalimumab biosimilars [1].

Iran approves its first rituximab biogeneric

Biosimilars/News | Posted 15/05/2015

In May 2015, Iran’s National Regulatory Authority, the Food and Drug Organization (FDO), approved its first rituximab biogeneric (Zytux). The medicine received its marketing authorization based on the previously published national guideline for marketing of biogenerics in Iran [1].

Biosimilar filgrastim highly similar to originator filgrastim

Biosimilars/Research | Posted 08/05/2015

A study comparing Sandoz’s filgrastim biosimilar (Zarzio) with originator filgrastim (Neupogen) has shown that they are highly similar in terms of their structure and function [1].

Clinical trials of biosimilars for psoriasis treatment

Biosimilars/Research | Posted 08/05/2015

Tumour necrosis factor-alpha (TNF-alpha) is a cytokine, or protein, that prompts the body to create inflammation. In psoriasis and psoriatic arthritis, there is excess production of TNF-alpha in the skin or joints. Therefore, drugs that block TNF-alpha, such as Enbrel (etanercept), Humira (adalimumab), Remicade (infliximab) and Stelara (ustekinumab), can be used to treat psoriasis and psoriatic arthritis.

Biosimilars Forum launched

Biosimilars/General | Posted 08/05/2015

A group of biosimilars developers in the US announced on 5 May 2015 the launch of a joint initiative to promote biosimilars in the form of the Biosimilars Forum.

Venezuelan approval for Celltrion’s Remsima

Biosimilars/News | Posted 08/05/2015

Celltrion announced on 29 April 2015 that it had received approval for its infliximab bioterapéuticos similares from the Venezuelan medicines agency, the Instituto Nacional de Higiene ‘Rafael Rangel’ (INHRR National ‘Rafael Rangel’ Institute of Hygiene).

Brazil approves first monoclonal antibody follow-on biological

Biosimilars/News | Posted 04/05/2015

Brazil’s medicines agency, the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA), announced on 27 April 2015 that it had approved its first follow-on biological medicine through ‘the development by comparability’.

Considerations when promoting generics prescribing in the US

Biosimilars/Research | Posted 04/05/2015

Sarpatwari and co-authors investigate the legal and ethical consideration for promoting generics prescribing in the US and how this might apply to biosimilars [1].

Australian guide to biosimilars

Biosimilars/General | Posted 04/05/2015

Australia’s Generic Medicines Industry Association (GMiA) has launched a Guide to Biosimilars. The guide is designed to provide a concise, ‘user-friendly’ reference on the subject for patients, clinicians, pharmacists, politicians and policymakers.

Adalimumab biosimilar meets primary endpoints in phase I study

Biosimilars/Research | Posted 04/05/2015

US biotech company Oncobiologics announced on 12 February 2015 that ONS-3010, its adalimumab biosimilar candidate, met the primary endpoints in its first clinical study.

WHO receives positive feedback on BQ for biologicals

Biosimilars/General | Posted 27/04/2015

According to the World Health Organization’s executive summary of its 59th Consultation on International Nonproprietary Names (INNs) for Pharmaceutical Substances, almost half of comments on its proposed biological qualifier (BQ) for naming biologicals were positive.

Promoting generics prescribing in the US

Biosimilars/Research | Posted 27/04/2015

Sarpatwari and co-authors discuss physician-centered strategies used to promote generics prescribing in the US and how such strategies might apply to biosimilars [1].

Samsung adds 48-week extension to SB4 biosimilar study

Biosimilars/News | Posted 27/04/2015

Samsung Bioepis has added a 48-week extension to the phase III study of its candidate etanercept biosimilar SB4 in rheumatoid arthritis patients.