Biosimilars

Brazilian approval for trastuzumab follow-on biological Herzuma (trastuzumab-pkrb)

Biosimilars/News | Posted 14/06/2019

South Korean biosimilars firm Celltrion announced on 23 May 2019 that the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA) had approved its trastuzumab follow-on biological, Herzuma (trastuzumab-pkrb).

UnitedHealthcare to prefer brand-name pegfilgrastim

Biosimilars/General | Posted 14/06/2019

US health insurance provider UnitedHealthcare has announced that it will prefer use of brand-name pegfilgrastim over the biosimilar versions.

Sandoz’s rosuvastatin approved under China’s new Quality Consistency Evaluation system

Biosimilars/News | Posted 14/06/2019

Sandoz, the generics division of Novartis, announced on 9 May 2019 that it had received regulatory approval from China's National Medical Products Administration (NMPA) for its generic rosuvastatin, under the recently introduced Quality Consistency Evaluation (QCE) system.

Biosimilars to replace older biologicals for IBD

Biosimilars/Research | Posted 07/06/2019

Biosimilars will gradually replace older biological drugs for IBD, however, issues – such as the safety of multiple switches – remain, says a recent assessment published in Digestive Diseases and Sciences [1].

Trastuzumab biosimilar Ogivri approved in Canada

Biosimilars/News | Posted 07/06/2019

India-based biologicals specialist Biocon and US-based partner Mylan announced on 22 May 2019 that Health Canada had approved Mylan’s trastuzumab biosimilar Ogivri.

Irish hospitals to get incentives to switch patients to biosimilars

Biosimilars/General | Posted 07/06/2019

Hospitals in Ireland are being offered a Euros 500 incentive for every patient they switch off two expensive biologicals to cheaper biosimilars.

Brazilian approval for trastuzumab follow-on biological Ontruzant

Biosimilars/News | Posted 07/06/2019

Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) announced on 27 May 2019 that the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA) had approved its trastuzumab follow-on biological, Ontruzant.

Dramatic price reduction of trastuzumab in Malaysia

Biosimilars/General | Posted 07/06/2019

The price of the cancer drug trastuzumab has dropped by more than half in Malaysia following a recent tender to the Ministry of Health.

NeuClone to start phase I trial for ustekinumab biosimilar

Biosimilars/News | Posted 31/05/2019

Australian biologicals company NeuClone announced on 15 May 2019 that it would start a phase I clinical trial of its ustekinumab biosimilar, NeuLara, in the second half of 2019.

Settlement for Udenyca and win for Zarxio

Biosimilars/General | Posted 31/05/2019

Amgen has made a settlement with respect to pegfilgrastim biosimilar Udenyca, but has lost its appeal against filgrastim biosimilar Zarxio.

Positive results for rituximab copy biological IBI301

Biosimilars/Research | Posted 31/05/2019

US-based pharma giant Eli Lilly, and its partner China-based Innovent Biologics (Innovent), announced on 7 May 2019 positive data from two clinical studies of their rituximab copy biological (IBI301) compared to Rituxan (rituximab).

Biocon/Mylan gain global rights to adalimumab biosimilar Hulio

Biosimilars/General | Posted 31/05/2019

India-based biologicals specialist Biocon and US-based partner Mylan announced on 7 May 2019 that they have gained the global rights to the adalimumab biosimilar Hulio.

GaBI Journal is the number one journal publishing on biosimilars

Biosimilars/Research | Posted 24/05/2019

The first ever global bibliometric analysis on biosimilars finds that GaBI Journal is the number one journal publishing on biosimilars. The study also shows that research on biosimilars is increasing, but is currently dominated by countries in the West such as the USA [1].

Recommendations published by Canadian breast cancer advocacy group

Biosimilars/General | Posted 24/05/2019

In April 2019, an advocacy group for patients with breast cancer in Canada – the Canadian Breast Cancer Network (CBCN) - published recommendations related to use of biosimilars in a white paper, entitled ‘Breast Cancer & Biosimilars Recommendations on Use, Implementation and Patient Communications’. These recommendations were informed by insights collected from virtual roundtable discussions with patients and medical oncologists.

Russian approval for non-originator eculizumab

Biosimilars/News | Posted 24/05/2019

Russian biotechnology company Generium and Swiss-based cell-line producer Selexis announced on 9 April 2019 that the Russian Ministry of Health had approved their eculizumab non-originator biological drug, Elizaria. The drug is a non-originator biological of Soliris (eculizumab), which is made by Alexion Pharmaceuticals.

BiosanaPharma starts phase I trial for omalizumab biosimilar in Australia

Biosimilars/Research | Posted 24/05/2019

Dutch biosimilars developer BiosanaPharma announced on 21 February 2019 that it had received permission from the Australian Bellberry Human Research Ethics Committee (HREC) to start a phase I clinical trial of their first pipeline product, omalizumab.

Canadian organizations collaborate to improve biosimilar adoption in cancer and inflammatory rheumatic and bowel disease

Biosimilars/General | Posted 17/05/2019

With a number of biosimilars expected to launch in Canada in 2019 and beyond, Canadian organizations are collaborating to improve biosimilar adoption. Canada lags behind the European Union in terms of approval and uptake of biosimilars [1].

Adalimumab biosimilar Idacio launched in Germany

Biosimilars/News | Posted 17/05/2019

Fresenius Kabi, one of the independently operated business segments of global healthcare group Fresenius, announced on 3 May 2019 that it had launched its adalimumab biosimilar Idacio in Germany.

ASCO/ASH give recommendations for biosimilar ESAs

Biosimilars/Research | Posted 17/05/2019

Recommendations for biosimilar erythropoiesis-stimulating agents (ESAs) in the management of cancer-associated anaemia have been issued by the American Society of Clinical Oncology (ASCO) and the American Society of Hematology (ASH).

Biosimilars education still needed for US and EU clinicians

Biosimilars/Research | Posted 10/05/2019

A review of the literature has concluded that healthcare providers are still cautious when it comes to biosimilars and that clinician-directed education is still needed to increase biosimilar knowledge, facilitate prescribing changes and increase use of biosimilars [1].