Biosimilars

Long-term safety results for adalimumab biosimilar

Biosimilars/Research | Posted 02/08/2019

ABP 501 is an adalimumab biosimilar which was compared to reference adalimumab in a 24-week phase lll study demonstrating equivalent efficacy and similar safety and immunogenicity [1]. The results of this clinical trial, along with the totality of evidence from analytical and biofunctional evaluation, lead to the approval of this adalimumab biosimilar for rheumatoid arthritis in the European Union and the US. ABP 501 is marketed as Amgevita in Europe and other markets. However, it will not be available in the US until 2023 due to an agreement between Amgen, the developer of the biosimilar, and AbbVie who manufactures the originator product, Humira (adalimumab) [2].

Positive phase III data for adalimumab copy biologicals

Biosimilars/Research | Posted 02/08/2019

Positive phase III data for adalimumab copy biologicals has been presented at the European Congress of Rheumatology 2019 (EULAR 2019) [1].

Lannett starts phase I trial for insulin glargine biosimilar in South Africa

Biosimilars/News | Posted 02/08/2019

US generics maker Lannett Company (Lannett) announced on 5 June 2019 that it had started a phase I clinical trial of its candidate insulin glargine biosimilar.

NHS England updates its ‘What is a Biosimilar Medicine?’

Biosimilars/General | Posted 02/08/2019

The National Health Service (NHS) England announced that it had updated its ‘What is a Biosimilar Medicine?’ document in June 2019.

EMA accepts application for bevacizumab biosimilar from Samsung Bioepis

Biosimilars/News | Posted 26/07/2019

Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) announced on 19 July 2019 that the application for approval for its proposed bevacizumab biosimilar SB8 has been accepted for review by the European Medicines Agency (EMA).

Positive results for rituximab non-originator and copy biologicals

Biosimilars/Research | Posted 26/07/2019

Positive results for the rituximab non-originator biological BCD-020 (AcellBia) and for the rituximab copy biological HLX01 (Hanlikon) have been presented at the European Congress of Rheumatology 2019 (EULAR 2019) [1, 2].

Positive phase III results for trastuzumab biosimilar HD201

Biosimilars/Research | Posted 26/07/2019

Singapore-based Prestige BioPharma (Prestige) announced on 24 June 2019 positive phase III data for its trastuzumab biosimilar, HD201. The results, according to Prestige, ‘confirm the similarities between HD201 and trastuzumab’.

South Korea increases investment in biologicals

Biosimilars/General | Posted 26/07/2019

Investment in the biotech sector is ramping up in South Korea, with increased state-led support and private sector pledges.

Sandoz to start phase III trial for denosumab biosimilar

Biosimilars/News | Posted 26/07/2019

Sandoz, the generics division of Novartis, is planning to start a phase III trial for its candidate denosumab biosimilar GP2411 in patients with post-menopausal osteoporosis in collaboration with Germany-based biosimilars maker Hexal.

FDA approves bevacizumab biosimilar Zirabev

Biosimilars/News | Posted 19/07/2019

US-based pharma giant Pfizer announced on 28 June 2019 that it had received approval from the US Food and Drug Administration (FDA) for its bevacizumab biosimilar Zirabev (PF-06439535).

Real-world data confirms safety of infliximab biosimilar CT-P13

Biosimilars/Research | Posted 19/07/2019

Positive real-world data has been presented for Celltrion’s infliximab biosimilar CT P13 at the European Congress of Rheumatology 2019 (EULAR 2019).

Clinical and real-world data for switching to biosimilars

Asian specialists' recommendations for off-patent biologicals in IBD

Biosimilars/Research | Posted 19/07/2019

Gastroenterologists from across Asia have published a list of recommendations for the use of biologicals and off-patent biologicals in inflammatory bowel disease (IBD) in Asia [1].

Positive phase III results for trastuzumab follow-on biological Zedora

Biosimilars/Research | Posted 19/07/2019

Results of a post-marketing study of Biocon and Mylan’s trastuzumab biosimilar Zedora (MYL-1401O) compared to Herceptin (trastuzumab) has shown equivalent safety data to the originator biological in breast and gastric cancer, according to the authors [1].

How local policy measures and practices influence originator biological and biosimilar market dynamics in Sweden

Biosimilars/Research | Posted 21/06/2019

The licensing of biologicals, including biosimilars, in Europe is centralized via the European Medicines Agency (EMA). Subsequently, individual European Member States are responsible for pricing, reimbursement and policies on market entry and use of medicines. This decentralized responsibility results in diverging approaches towards market entry and uptake of biosimilars and contributes to variation in the use of biosimilars across European countries, and even within countries differences in biosimilar uptake levels exist. The latter is the case for the 21 counties of Sweden, implying that decisions taken by their county councils play a role in market access of biosimilars, alongside policy measures and incentives provided at the national level.

FDA approves trastuzumab biosimilar Kanjinti

Biosimilars/News | Posted 21/06/2019

US-based pharma giant Amgen and Netherlands-based Allergan announced on 13 June 2019 that it had received approval from the US Food and Drug Administration (FDA) for its trastuzumab biosimilar Kanjinti (ABP 980).

Recommendations for similar biotherapeutic products published by Latin American MS experts

Biosimilars/Research | Posted 21/06/2019

Recommendations for the use of similar biotherapeutic products for multiple sclerosis (MS) have been issued by a group of experts from Argentina, Bolivia, Brazil, Chile, Colombia, Costa Rica, Ecuador, Mexico, Panama, Peru, Uruguay and Venezuela.

Alteogen gains approval to start aflibercept biosimilar trial in Korea

Biosimilars/News | Posted 21/06/2019

South Korean biologicals company Alteogen announced on 22 May 2019 that it had gained approval from the Korean Ministry of Food and Drug Safety (MFDS) to initiate a clinical trial for its aflibercept biosimilar, ALT‑L9.

Positive phase I results for Bio-Thera’s bevacizumab copy biological

Biosimilars/Research | Posted 21/06/2019

China-based Bio‑Thera Solutions (Bio‑Thera) has published phase I results for its candidate bevacizumab copy biological, BAT1706 [1].

Is switching to biosimilar infliximab safe?

Biosimilars/Research | Posted 14/06/2019

Building on a number of studies on biosimilar infliximab for inflammatory bowel disease (IBD), a recent review shows switching to CT-P13 is safe, but more evidence is needed on switching back to originator and switching between biosimilars [1].

Trastuzumab biosimilar from Prestige accepted for review by EMA

Biosimilars/News | Posted 14/06/2019

Singapore-based Prestige BioPharma (Prestige) announced on 28 May 2019 that the regulatory submission for its proposed trastuzumab biosimilar Tuznue (HD201) had been accepted by the European Medicines Agency (EMA).

Eli Lilly launches lower-priced insulin lispro

Biosimilars/General | Posted 14/06/2019

Eli Lilly announced on 22 May 2019 that it had launched the lower-priced authorized biosimilar version of its diabetes treatment Humalog (insulin lispro) in the US.

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.