Biosimilars
Russian approval for non-originator dornase alfa
Russian biotechnology company Generium and Swiss-based cell-line producer Selexis announced on 17 September 2019 that the Russian Ministry of Health had approved their dornase alfa non-originator biological drug, Tigerase. The drug is a non-originator biological of Roche’s Pulmozyme (dornase alfa).
Celltrion and Juno make biosimilars deal in Australia and Herzuma launches in Iraq
South Korean biotechnology company Celltrion Healthcare (Celltrion) has entered into a partnership with Juno Pharmaceuticals (Juno) to market the trastuzumab biosimilar Herzuma and rituximab biosimilar Truxima in Australia. The company also launched Herzuma in Iraq.
Trial of bevacizumab copy biological with novel antibody targeting PD-1
China-based Shanghai Henlius Biotech (Henlius) is recruiting patients for a study that will investigate a proposed bevacizumab copy biological in combination with a novel antibody targeting PD-1.
Clinical data requirements for biosimilars in the EU
In their article [1], authors from the Paul-Ehrlich-Institut, the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) discussed the clinical data requirements for biosimilars in the European Union (EU).
FDA approves Pfenex’s follow-on teriparatide product
US-based biotech firm Pfenex announced on 7 October 2019 that it had received approval from the US Food and Drug Administration (FDA) for its follow-on teriparatide product (PF708).
Biocon/Mylan launch first insulin glargine biosimilar in Australia
India-based biologicals specialist Biocon and US-based partner Mylan announced on 3 October 2019 the launch of the first insulin glargine biosimilar in Australia available on the Pharmaceutical Benefits Scheme (PBS).
FDA releases new patient guidance on biosimilars
The US Food and Drug Administration (FDA) has released new patient materials on biosimilars, which explain that biosimilars are as safe and effective as their reference biological and answer a number of commonly asked questions.
Adalimumab copy biological shown to be safe and effective
Chinese biopharmaceutical firm Innovent Biologics’ adalimumab copy biological has shown comparable safety and efficacy to the originator drug, Humira (adalimumab), in patients with ankylosing spondylitis.
Biosimilars applications reviewed in the EU
The European Union (EU) was the first to establish a legal framework for biosimilars back in 2003 [1]. Since the European Medicines Agency (EMA) approved its first biosimilars in 2006, the agency has issued new guidelines and updated its existing guidelines based on new evidence and rapid advances in analytical sciences [2].
Three darbepoetin alfa biosimilars approved in Japan
Three pharmaceutical companies have announced approval of their anaemia treatments for sale on the Japanese market, while Mochida reveals it will sell the first teriparatide biosimilar in the country.
