Biosimilars/General
Biobetters rather than biosimilars
‘Biobetters’, rather than biosimilars, are the next big opportunity for biopharm and contract research organisations (CROs) hoping to profit from patent expirations on biologicals, say experts.
The history of the US biosimilar regulatory pathway
The US, although it now has a legal pathway (with the approval of the Biologics Price Competition and Innovation Act [BPCI Act], which was signed into law on 23 March 2010 by President Barack Obama), does not yet have a practical pathway with guidance defined by the FDA.
More debate over the exclusivity period for biological in the US
The debate over the length of exclusivity that biological drugs can enjoy before competition from biosimilars ensues seems set to be a long and complicated one. The latest group to join in the debate is the Office of the US Trade Representative (USTR).
Questions over US biosimilars pathway in light of Teva’s BLA
Questions have arisen over whether the abbreviated pathway for approval of biosimilars in the US will ever be used. Many believe that biosimilars manufacturers will opt out of this pathway and use the normal route via a Biologic License Application (BLA). This is backed up by the fact that Teva’s biosimilar, Neutroval, was submitted to the FDA via the normal BLA route.
Global biosimilar market to grow to US$3.7 billion in 2015
According to a report by Datamonitor published on 23 February 2011 the global biosimilars market will grow from US$243 million in 2010 to US$3.7 billion in 2015.
Are biosimilars an easy option for big money
With the recent JP Morgan 29th Annual Healthcare Conference 2011 in San Francisco, US came a chance for reporters to quiz all the big name firms in one easy sweep. The result reported by Reuters is that the pharma industry is poised to dive into biosimilars.
US Senate healthcare bill preserves biologicals exclusivity, but charges annual drugmaker fees
The recently released US Patient Protection and Affordable Care Act, H.R. 3590, will ensure that all Americans have access to quality, affordable health care and will create the transformation within the healthcare system necessary to contain costs.
The hurdles to biosimilars in Europe
The stage is set for the entrance of biosimilars into the healthcare market. Patents are near expiry on the first biopharmaceuticals and the global biosimilars market is predicted to be worth more than Euros 1.5 billion by 2015. However, development costs will be high, unlike with generic drugs, the time taken to develop biosimilars is long, and acceptance on the market is not guaranteed.
Hurdles to entering the biosimilars’ market
Yet more hurdles to entering the biosimilars’ market have been identified in a Reuters’ report. High development costs, complex manufacturing and legal hurdles are holding back generic drugmakers seeking to copy high cost biotech medications nearing the end of their patents.
Biosimilars’ hurdles in the US
Europe serves as a model for other countries looking to define their own regulatory approval criteria. However the opposing interests of biosimilar and innovative companies is resulting in delays to the development of biosimilars in the US.
