Biosimilars

EULAR recommendations for DMARDs in rheumatoid arthritis

Biosimilars/Research | Posted 26/06/2020

The European League Against Rheumatism (EULAR) has updated its recommendations on the management of rheumatoid arthritis (RA) using synthetic and biological disease-modifying antirheumatic drugs (DMARDs) [1].

Medscape hosts virtual symposium on biosimilars in IBD

Biosimilars/General | Posted 26/06/2020

Medscape held a virtual symposium on the use of biosimilars in inflammatory bowel disease (IBD) on 30 May 2020. The event covered issues including the regulatory approval process for biosimilars, research on biosimilars and switching.

FDA approves insulin glargine biosimilar Semglee

Biosimilars/News | Posted 19/06/2020

US-based drugmaker Mylan and partner, India-based biologicals specialist Biocon, announced on 11 June 2020 that it had received approval from the US Food and Drug Administration (FDA) for its insulin glargine biosimilar Semglee (MYL‑1501D).

Positive phase Ib results for TYVYT + bevacizumab copy biological IBI305

Biosimilars/Research | Posted 19/06/2020

China-based Innovent Biologics (Innovent) announced on 1 June 2020 positive results for a phase I trial of its candidate bevacizumab copy biological, IBI305, in combination with TYVYT (sintilimab injection) in the treatment of advanced hepatocellular carcinoma, which is the most common form of liver cancer.

Daewon launches teriparatide biosimilar in South Korea

Biosimilars/News | Posted 19/06/2020

South Korea-based Daewon Pharmaceutical (Daewon) announced that it has launched the teriparatide biosimilar Terrosa.

Clinical equivalence in oncology biosimilar trials

Biosimilars/Research | Posted 19/06/2020

Researchers from the US propose using restricted mean survival time (RMST) rather than the overall response rate (ORR) and progression-free survival (PFS) or overall survival (OS) in clinical trials evaluating the equivalence of biosimilars [1].

Switching from biologicals to biosimilars in Australia

Biosimilars/General | Posted 19/06/2020

Switching* patients from originator biologicals to biosimilars has been a topic of keen interest in recent years across the globe, as more biosimilars have emerged onto the market. Authors from Shelston Intellectual Property discussed the unique approach that Australia has taken to switching.

Fresenius Kabi’s pegfilgrastim biosimilar accepted for review by EMA and FDA

Biosimilars/News | Posted 12/06/2020

Fresenius Kabi, the generics unit of German healthcare giant Fresenius, announced on 22 and 27 May 2020 that the regulatory submissions for its proposed pegfilgrastim biosimilar (MSB11455) had been accepted by both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), respectively.

Use of biosimilar infliximab gives savings for patients

Biosimilars/Research | Posted 12/06/2020

Canadian researchers carried out a cost-utility analysis of switching from reference to biosimilar infliximab compared to maintaining reference infliximab in adult patients with Crohn’s disease (CD). From this analysis they found that using biosimilar infliximab resulted in cost savings for patients [1].

China accepts IND application for denosumab copy biological HLX14

Biosimilars/News | Posted 12/06/2020

China-based drugmaker Shanghai Henlius Biotech (Henlius) announced on 27 May 2020 that China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), had accepted an investigational new drug application (IND) for HLX4, a denosumab copy biological.

ISOPP publishes a whole host of information on biosimilars

Biosimilars/General | Posted 12/06/2020

The International Society of Oncology Pharmacy Practitioners (ISOPP) has published a whole host of information on biosimilars in a supplementary issue of the Journal of Oncology Pharmacy Practice.

First subjects dosed in Australian phase I study of denosumab biosimilar

Biosimilars/Research | Posted 12/06/2020

Taiwan-based JHL Biotech announced on 18 May 2020 that the first group of subjects has been randomized and dosed in the week of 11 May 2020 in the company’s Australian phase I clinical trial of its candidate denosumab biosimilar (JHL1266) in healthy subjects.

WHO prequalifies first rituximab biosimilar

Biosimilars/General | Posted 05/06/2020

The World Health Organization (WHO) has prequalified its first rituximab biosimilar as part of its efforts to make life-saving treatments more affordable and available to patients globally.

EMA recommends approval of trastuzumab biosimilar Zercepac

Biosimilars/News | Posted 05/06/2020

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 29 May 2020 that it had recommended granting of marketing authorization for a biosimilar trastuzumab product.

Teva launches rituximab biosimilar Truxima in US

Biosimilars/News | Posted 05/06/2020

Israeli generics giant Teva Pharmaceutical Industries (Teva) and partner, South Korean biotechnology company Celltrion, announced on 4 May 2020 that they had launched their rituximab biosimilar Truxima (TL011) in the US.

Biosimilar Awareness Week in Australia

Biosimilars/General | Posted 05/06/2020

The second Biosimilar Awareness Week took place on 25–29 May 2020 in Australia. It involved discussion on social media and aimed to increase awareness and confidence in biosimilars among consumers and healthcare professionals.

Samsung Bioepis releases data on trastuzumab and ranibizumab biosimilars

Biosimilars/Research | Posted 05/06/2020

Samsung Bioepis has released follow-up data for its approved trastuzumab biosimilar Ontruzant, as well as interim results for its proposed Lucentis (ranibizumab) biosimilar.

Patients’ perceptions of switching to biosimilars

Biosimilars/Research | Posted 05/06/2020

A patient’s characteristics make them more likely to have negative perceptions about switching to biosimilars, according to a study by researchers from New Zealand [1].

Safety of switching between reference products and biosimilars

Biosimilars/Research | Posted 29/05/2020

The safety of switching a patient under chronic treatment with a reference biological to a biosimilar has been a topic of ongoing debate since the first biosimilar approval in Europe in 2006. The topic sparked further discussion with the arrival of the more complex monoclonal antibody biosimilars. Concerns have been raised that switching between highly similar but non-identical versions of a biological medicine might lead to increased immunogenicity and as such, impact treatment outcomes. The existing stakeholder uncertainty regarding the safety of switching may have been curbing the use of biosimilars in clinical practice and guidance to support healthcare professionals with clinical decision-making is needed.

Amgen explains the steps of manufacturing a biosimilar

Biosimilars/General | Posted 29/05/2020

US-based biotech giant Amgen explains on its websites the steps involved in manufacturing a biosimilar.