Biosimilar drugs are the new generics, as the NHS looks to cut hundreds of millions of pounds off its annual budgets by using any of four copies of Herceptin and then others; unfortunately, generic drugs have become highly controversial as an increased focus on cost savings went hand in hand with a lack of oversight by health authorities. Will Biosimilar drugs suffer the same fate?
The FDA and the European Medicines Agency have now both approved Samsung Bioepis’ Ontruzant, a cheaper copy of Herceptin. It is estimated that the move will save the NHS over 200 million pounds in 2020. The EMA has also approved three other copies only the past 18 months - Herzuma, Kanjinti, and Ogivri. There is one slight difference between the new Biosimilars and the old generics - the Herceptin patent will still be in place, when the biosimilars come into use. Previously, generics were only sold when the original drugs came off patent.
The previous issues with Generic Drugs were straightforward. 'Were they as good?' And given that 90% of American drugs are gererics and 93% of generics came from South East Asia, India and China, ‘Was there ongoing quality control?’ The last point was answered when the FDA admitted that only 3% of drugs arriving in the USA were ever checked for quality. No equivalent figure was provided for Europe.
In theory, generic drugs were required by the Health Authorities to be as safe and as effective as the brand name drugs. Bioequivalency is the crucial word. But as these were copies with no upfront development costs and no expensive marketing and promotional costs, generics could cost just 10% to 20% of the brand name drug. And in the end, the Health Authorities focussed more and more on cost, so corners were cut by suppliers in areas of ingredients and production.
An expose by investigative journalist Katherine Eban lead to a book 'Bottle of Lies', which details fraudulent practices at the Generic drug companies plus a lack of oversight, control, lack of testing, and lack of action at the FDA. Meanwhile Doctors were noticing issues with poor performance of Generic drugs but were powerless to do much about it all.
It was a big worry - and it still is. Health bodies such as the FDA or the NHS that approve the use of Biosimilar drugs need to prove that they are capable of regulating them beyond asking about the price.
Go to: 2019 report on Generic Drug failures
So is the Ontruzant copy as good as Herceptin?
Samsung Bioepis recently presented safety and efficacy results for the biosimilar at the 2018 San Antonio Breast Cancer Symposium, held in San Antonio, Texas. Apparently, there was no statistically significant difference in event-free survival between the biosimilar arm (96.7%) and the patients who were unexposed to the real deal (98.2%). Readers will note that a 1.5% lower figure might not be statistically different to a mathematician, but a lady with HER2 breast cancer might disagree.
And who knows how well the drug will be tested and regulated in 5 years time?