Biosimilars

EMA approval for pegfilgrastim biosimilar Grasustek

Biosimilars/News | Posted 10/05/2019

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 26 April 2019 that it had recommended the granting of a marketing authorization for the pegfilgrastim biosimilar Grasustek.

Patient and provider views on biosimilars to treat breast cancer

Biosimilars/General | Posted 10/05/2019

A Canadian breast cancer advocacy group collected insights from patients and medical oncologists regarding the use of biosimilar treatments.

Pharmacokinetic assessment of biosimilar therapeutic monoclonal antibodies

Biosimilars/Research | Posted 10/05/2019

Comparison of the clinical pharmacokinetic (PK) profile of a biosimilar with that of the reference product is an important step in the development of biosimilars. In a recent review, Ishii-Watabe and Kuwabara outline key considerations for the comparative studies required for biosimilar development, focusing on the clinical PK profiles of biosimilar therapeutic monoclonal antibodies (mAbs) and their reference products [1].

FDA approves etanercept biosimilar Eticovo

Biosimilars/News | Posted 03/05/2019

Korean biosimilars maker Samsung Bioepis (Samsung and Biogen’s joint venture) announced on 25 April 2019 that it had received approval from the US Food and Drug Administration (FDA) for its etanercept biosimilar.

ASCO/ASH update ESA recommendations

Biosimilars/Research | Posted 03/05/2019

The American Society of Clinical Oncology (ASCO) and the American Society of Hematology (ASH) have updated their recommendations on the management of cancer-associated anaemia with erythropoiesis-stimulating agents (ESAs).

Biosimilar comparability assessment

Biosimilars/Research | Posted 03/05/2019

In a recent review, Ishii-Watabe and Kuwabara summarize the principles of biosimilar development and outline key considerations for studies comparing a biosimilar with its reference product [1].

FDA to hold public meeting on access to affordable insulin

Biosimilars/General | Posted 26/04/2019

The US Food and Drug Administration (FDA) is seeking input on the challenges and opportunities the agency should consider as it prepares for the submission and review of applications for biosimilar and interchangeable insulin products, as well as about the development process for such products.

Comparability of biosimilar Ontruzant maintained over three years

Biosimilars/Research | Posted 26/04/2019

Samsung Bioepis has presented positive long-term results for its trastuzumab biosimilar Ontruzant (SB3) at the 16th International Maternal Cancer Congress St Gallen 2019, which was held in Vienna, Austria.

Intas launches trastuzumab similar biologic in India at 65% discount

Biosimilars/News | Posted 26/04/2019

India-based generics maker Intas Pharmaceuticals (Intas) announced on 9 April 2019 the launch of its product Eleftha, a ‘similar biologic’ of trastuzumab, in India. The new product, claims the company, will bring down the cost of breast cancer treatment by nearly 65%.

Clinical development of a bevacizumab biosimilar

Biosimilars/Research | Posted 26/04/2019

Authors, Kambiz Novin and Nafiseh Mortazavi, from medical faculties of Iranian Universities, discuss the methodological considerations for the clinical development of a bevacizumab biosimilar [1].

Biosimilar drug packaging does not meet EU guidelines on readability

Biosimilars/Research | Posted 19/04/2019

Analysis of 35 biosimilar medicines licensed by the European Medicines Agency (EMA) finds packaging to be more complex than recommended. None of the packaging leaflets analysed were found to be ‘easy to understand’, with sections on therapeutic indication and side effects found to be the most complex [1].

Rituximab biosimilar Truxima approved in Canada

Biosimilars/News | Posted 19/04/2019

Teva Canada Innovation, a subsidiary of Teva Pharmaceutical Industries, announced on 10 April 2019 that Health Canada had approved its rituximab biosimilar Truxima. This marks the first rituximab biosimilar to be approved by the Canadian medicines’ regulator.

Eli Lilly to introduce half-price authorized insulin biosimilar in US

Biosimilars/General | Posted 19/04/2019

With high drug prices increasingly coming into the spotlight, Eli Lilly has announced that it will introduce a lower-priced authorized biosimilar version of its diabetes treatment Humalog (insulin lispro) in the US.

Economic considerations for biosimilars in the US

Biosimilars/Research | Posted 19/04/2019

Smeeding and colleagues explore cost considerations related to biosimilars in the US, and present a broad perspective on value beyond price reduction in a recent review.

EC approval for adalimumab biosimilar Idacio

Biosimilars/News | Posted 12/04/2019

Fresenius Kabi, the generics unit of German healthcare giant Fresenius, announced on 3 April 2019 that it had received European Commission (EC) approval for its adalimumab biosimilar Idacio (MSB11455).

Efficacy and safety of bevacizumab biosimilar ABP 215

Biosimilars/Research | Posted 12/04/2019

Authors from the US and Europe report data from a phase III study comparing the clinical efficacy and safety of the bevacizumab biosimilar ABP 215 (Mvasi) with originator bevacizumab Avastin in patients with advanced non-squamous non-small cell lung cancer (NSCLC) [1].