Biosimilars
What happened in biosimilars during 2015
The past year has once again been a busy one for the biosimilars industry [1]. The most important milestone achieved during 2015 was the landmark decision made by the US Food and Drug Administration (FDA) on 6 March 2015 to approve Sandoz’s filgrastim biosimilar, Zarxio (filgrastim-sndz), for all five indications of the originator product (Neupogen). FDA is also reviewing applications for epoetin alfa, infliximab, etanercept filgrastim and pegfilgrastim biosimilars.
Domestic biologicals cost less in India
One of the factors increasing the use of similar biologics in India is the fact that domestic biologicals cost much less than the originator brand-name biologicals [1].
Bevacizumab non-originator biological approved in Russia
Russian biotechnology company Biocad announced on 30 November 2015 that the Russian Ministry of Health had approved the company’s bevacizumab non-originator biological drug, BCD-021. The drug is a non-originator biological of Roche’s cancer blockbuster Avastin (bevacizumab).
Barriers to biologicals competition
As finding breakthrough small-molecule drugs becomes more difficult, drug companies are increasingly turning to ‘large molecule’ biologicals. Although biologicals represent many of the most promising new therapies for previously intractable diseases, they are extremely expensive. Moreover, the pathway for generic-type competition set up by the US Congress in 2010 is unlikely to yield significant cost savings.
EMA accepts application for etanercept biosimilar
Sandoz, the generics division of Novartis, announced on 8 December 2015 that the regulatory submission for its proposed etanercept biosimilar (GP2015) had been accepted by the European Medicines Agency (EMA).
Low costs and less stringent regulatory requirements in India
Dr Nagaraj Malipatil, a clinical pharmacologist, from Bangalore, India in his review of ‘similar biologics’ in India, outlines some of the drivers of the ‘similar biologics’ market in India [1].
FDA approves first follow-on insulin glargine treatment
The US Food and Drug Administration (FDA) announced on 16 December 2015 that it had approved Eli Lilly/Boehringer Ingelheim’s biosimilar version of Sanofi’s Lantus (insulin glargine) diabetes treatment.
Inflectra PBS listing expected to deliver savings in Australia
The infliximab biosimilar Inflectra was approved for listing in Australia’s Pharmaceutical Benefits Scheme (PBS) on 1 December 2015. This is a decision that ‘will deliver immediate savings’ to the Australian Government, according to the Generic and Biosimilar Medicines Association (GBMA), a group that represents generic and biosimilar medicine suppliers in Australia.
Pegfilgrastim biosimilar as safe and effective as Neulasta
Sandoz, the generics division of Novartis, announced on 7 December 2015 positive results from a phase III study of its pegfilgrastim biosimilar (LA-EP2006).
Factors affecting the uptake of ‘similar biologics’ in India
In his review of similar biologics in India, Dr Nagaraj Malipatil, a clinical pharmacologist from Bangalore, attempted to address what are the drivers and the limitations to the ‘similar biologics’ market in India [1].
