2015 was the year biosimilars finally delivered on the hype. In February, Napp and Hospira launched Celltrion’s biosimilar infliximab, challenging MSD’s Remicade and potentially saving the NHS millions.
Other filings in the year including Novartis’ copycat of Pfizer’s Enbrel and Amgen’s version of AbbVie’s Humira. Novartis’ biosimilar of Amgen’s Neupogen became the first biosimilar to launch in the US after the latter company failed to block its sale in a landmark legal case.
Alignment is crucial
for patient access
The NHS challenge of £22b in efficiency savings by 2020 was
a key theme for 2015, and the launch of biosimilar infliximabs presented an
opportunity for significant NHS savings. However, there was a slow start to
uptake, which highlighted barriers that prevent swift local change from more
costly interventions when lower cost alternatives become available.
This seeming misalignment between government priorities and
local reality has many causes, including competing local concerns and, yet
again, the absence of integrated decision-making. If the NHS is to gain from
efficiency improvements and channel this into improved care, it needs a
whole-system approach and clear instruction when it comes to medicines.
We hope that the Accelerated Access Review will provide some
answers. Things are now moving in a more positive direction, with NHS England
setting some actionable goals around infliximab, and wider policies being
explored to help solve some of the local issues. Policy success, though, is all
about implementation. For new policies to work, plans, practical guidance,
incentives and monitoring must all align.
growth products business unit director,
Compelling data needed for biosimilar success
Monoclonal antibodies are complicated medicines and when biosimilar infliximab was launched there were some concerns about whether its efficacy and safety would be comparable to its originator product. There was particular hesitation about switching patients already on originator products to a biosimilar medicine.
Over the last couple of years a wealth of supporting data has been published in medical journals and presented at global congresses, including real-world data of patients who have been switched to the new drug from the originator. This has led to a positive change in physician and patient attitudes towards biosimilars.
In the coming years, more biosimilars will come on to the market, accelerating the uptake of biosimilar medicines and creating competition. New biosimilars will need to provide compelling data, including data for patients switched from the originator and switching between biosimilars, which will help build physician confidence in these treatments.
As market penetration for biosimilars expands, this will lead to increased cost-savings for health services and greater treatment opportunities for patients.
Dr SeungSuh 'Stanley' Hong, president and chief executive officer, Celltrion Healthcare