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).
Biocon/Mylan launch first insulin glargine biosimilar in Australia
Biosimilars/News | Posted 11/10/2019 0 Post your comment
Insulin glargine is a long-acting basal insulin analogue, given once daily to help control the blood sugar level of those with diabetes. It consists of microcrystals that slowly release insulin, giving a long duration of action of 18 to 26 hours. Insulin glargine is indicated for the treatment of diabetes mellitus in adults, adolescents and children aged two years and above.
Australia’s regulatory agency, the Therapeutic Goods Agency (TGA) approved Biocon/Mylan’s insulin glargine biosimilar, Semglee, in March 2018 [1]. TGA’s approval of Semglee was based on robust data that demonstrated that Semglee is highly similar to the reference insulin glargine, with no clinically meaningful differences in efficacy, safety, purity and potency. The biosimilar will be available as a solution for injection 100 IU/mL in a 3 mL pre-filled pen.
Almost two million Australians have diabetes, with 280 Australians developing diabetes every day – one person every five minutes. The total annual cost impact of diabetes in Australia is estimated at AU$14.6 billion [2].
Australia has made significant efforts to create a competitive and sustainable biosimilars market. The Australian Government committed to the Biosimilar Awareness Initiative in 2015 and more recently provided the Generic and Biosimilar Medicines Association with AU$5 million in funding to promote the use of biosimilars.
Mylan and Biocon’s insulin glargine biosimilar is currently approved in more than 40 countries around the world.
Related articles
Australia encouraging biosimilars and mandating drug shortage reporting
Biosimilars of insulin glargine
References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Australia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Oct 11]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Australia
2. GaBI Online - Generics and Biosimilars Initiative. Mylan launches first trastuzumab biosimilar in Australia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Oct 11]. Available from: www.gabionline.net/Biosimilars/News/Mylan-launches-first-trastuzumab-biosimilar-in-Australia
Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.
Copyright – Unless otherwise stated all contents of this website are © 2019 Pro Pharma Communications International. All Rights Reserved.
Source: Biocon
Research
Long-term real-world safety experience of biosimilars confirms concept of biosimilarity
Budget impact analysis of Rixathon introduction in Chile for non-Hodgkin lymphoma
General
Biosimilar medicines on the Pharmaceutical Benefits Scheme in Australia
SBR issues consensus on interchangeability of reference products and biosimilars
Comments (0)
Post your comment