Biosimilars
Intas launches trastuzumab similar biologic in India at 65% discount
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
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
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
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
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
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
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
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].
Key considerations for biosimilars in the US
Key considerations regarding biosimilars for payers in the US are discussed in a recent review [1]. The authors explore factors promoting the uptake of biosimilars, interchangeability and naming considerations, and challenges to uptake.
Biocad advancing its non-originator biologicals in Russia
Russian biotechnology company Biocad has started an eculizumab study and has also registered its non-originator biological (BCD 057) in Russia.