- NHS England, the national health service for a large chunk of Britain, negotiated deals with five drugmakers to gain access to lower-cost versions of AbbVie's Humira, the world's best-selling drug.
- The health service said about £300 million ($383 million) in anticipated savings would be "the biggest in NHS history from a single drug negotiation." The deals will reduce hospitals' Humira bills by around three-quarters and could "pay for 11,700 more community nurses or 19,800 more breast cancer treatments for patients," NHS said.
- In a separate cost-cutting move, NHS signed a voluntary agreement with the Association of British Pharmaceutical Industries over medicine pricing and access between 2018 and 2023, seeking a balance between patient access, affordability and supporting development of new medicines.
NHS England's negotiations exemplify how European governments can make the most of biosimilar pricing and the wave of competition triggered by biosimilar entry.
More than 46,000 patients across England are treated with Humira (adalimumab) each year, costing more than £400 million a year. The move to biosimilars is starting to make a significant difference to the amount that governments in Europe are spending on biologic therapeutics, with discounting on branded biologics reaching as much as 80%.
The expected savings are based on bids from four companies who manufacture biosimilar versions of AbbVie's Humira as well from as AbbVie itself.
The biosimilars will include: Amgen's Amgevita, Biogen's Imraldi, Mylan and Fujifilm Kyowa Kirin's Hulio and Sandoz' Hyrimoz. The cost savings associated with biosimilars aren't just from the lower list prices of copycat biologics but also from the competition that they trigger. This can impact the prices offered for the originator molecule.
"NHS England has now freed up hundreds of millions of pounds of savings to reinvest in patient care," said Simon Stevens, NHS England’s chief executive. "By working with patients and frontline clinicians we’ve now successfully negotiated the biggest ever set of savings on what was the NHS’s most costly drug."
NHS England declined to provide the average discount versus branded Humira price to BioPharma Dive, citing confidentiality.
Biosimilars are more widely available in Europe compared with the U.S., which created a regulatory pathway later. There are 14 biosimilars approved in the U.S., though only half of those have reached the market because of litigation with originator companies.
"This is another example of how the smarter approach to biosimilar medicines in the UK and Europe gives patients and taxpayers a much better deal than they get in the United States," Stevens said.
The Food and Drug Administration has been trying to promote market acceptance of biosimilars, as well as get them through the regulatory process quickly and efficiently.
FDA Commissioner Scott Gottlieb announced in March that up to a dozen new policies were in development. However, an industry pushback has spurred withdrawal of an FDA biosimilar draft guidance, and the agency is working on a new draft guidance addressing some of the comments received.